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PDA Glossary

PDA Glossary of Pharmaceutical and Biotechnology Terminology

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.

Browse Terms by Title

 

Browse Terms by TR #

 
 
  • Active Systems

    Systems with active temperature control (e.g., air/sea freight containers, refrigerated trucks/cars). (TR39)

    System with active temperature control. It makes use of electricity or fuel for the compressor to maintain temperature. Examples include refrigerated trucks, temperature-controlled ocean containers, and active ULDs. (TR58)

    Actively powered system that uses electricity or other fuel source to maintain a temperaturecontrolled environment inside an insulated enclosure under thermostatic regulation (e.g., cold room, refrigerator, temperature-controlled truck, refrigerated ocean or air container). (TR64) (TR72)

    (Synonym: Active Temperature Controlled System)

  • Active Temperature Controlled System

    Actively powered system that uses electricity or other fuel source to maintain a temperaturecontrolled environment inside an insulated enclosure under thermostatic regulation (e.g., cold room, refrigerator, temperature-controlled truck, refrigerated ocean or air container). (TR 72) (TR64)

  • Active Unit Load Device (Active ULD)

    A Unit Load Device (ULD) container used to consolidate cargo on aircraft that contains electrical or battery-powered temperature control systems for transporting temperature-sensitive materials; an RKN type is used in an FMEA example. (TR58)

    A unit load device with an active heating and/or cooling system that is typically used in air transportation, usually operated from externally supplied AC or DC power or from internal batteries. (TR64)

  • Active Unit Load Device (ULD)

    A Unit Load Device (ULD) container used to consolidate cargo on aircraft that contains electrical or battery-powered temperature control systems for transporting temperature-sensitive materials; an RKN type is used in an FMEA example. (TR58)

    A unit load device with an active heating and/or cooling system that is typically used in air transportation, usually operated from externally supplied AC or DC power or from internal batteries. (TR 64)

  • Ambient Temperature

    The air temperature of an environment. (TR58)

  • Analytical Method Transfer (AMT)

    Documented process that qualifies a laboratory (receiving unit) to use an analytical test procedure that originates in another laboratory (the transferring unit, also known as the sending unit), thus ensuring that the receiving unit has the knowledge and ability to perform the transferred analytical procedure as intended. (TR57-2)

  • Analytical Platform Technology (APT)

    An analytical method that is used for multiple products and/or types of sample matrix without modification of the procedure. Similar to compendial methods, an APT method may not require full validation for each new product or sample type. (TR57)

  • Ancillary Packaging Components/Systems

    Additional means used in combination with the basic transportation unit to maintain the required temperature during transport. Examples include active systems and passive systems. (TR39)

  • Animal-Derived Raw Materials (Primary)

    Contains in the final raw material or uses in the manufacturing process of the final raw material, any raw material derived directly from bovine or other animal tissues, for example, bovine serum, porcine-derived trypsin, and animal-tissue-de­rived hydrolysates. (TR83)


  • Archival (MHRA )

    A designated secure area or facility (e.g., cabinet, room, building or computerised system) for the long-term retention of data and metadata for the purposes of verification of the process or activity.(TR80)

  • Archival (WHO)

    The process of protecting records from the possibility of being further altered or deleted, and storing these records under the control of independent data management personnel throughout the required retention period.(TR80)

  • Assay

    Analytical method used to determine the purity or concentration of a specific substance in a mixture. (TR 26)

  • Audit Trail (FDA)

    A secure, computer-generated, timestamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. An audit trail is a chronology of the "who, what, when, and why" of a record.(TR80)

  • Audit Trail (MHRA)

    Metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the "who, what, when and why" of the action.(TR80)

  • Audit Trail (WHO)

    The audit trail is a form of metadata that contains information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions, or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record.(TR80)

  • Bacteriophage

    A bacteriophage is any one of a number of viruses that infect bacteria. The term is commonly used in its shortened form, “phage”. (TR41) (TR 47)

  • Batch Filtration Process

    In a batch filtration process, the entire volume to be filtered is held in a single feed tank. The retentate stream is recycled back to that single feed tank. (TR15)

  • Bracketing

    A demonstration of unit operation performance at two different values of a given parameter (e.g., ionic strength, dwell time or temperature), allowing the use any values of that parameter falling within this range. (TR41)

  • Bracketing Approach

    A scientific approach for defining product/load characteristics (e.g., viscosity, container sizes, container fill volumes, item sizes, loading configurations) that are tested (in a qualification study or validation study) at upper and/or lower limits. (TR1) (TR61)

    A validation method that tests the extremes of a process or product. The method assumes the extremes will be representative of all the samples between the extremes. (TR26)

  • British Thermal Unit (BTU)

    The amount of heat (measured in Joules) required to raise the temperature of one pound of water by 1ºF.(TR64)

  • Change Management

    A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. (TR 51) (TR 54-5)

  • Changeover

    The steps taken for switching multiproduct equipment from the manufacture of one product to the manufacture of a different product. (TR29) (TR49)

  • Cold Chain

    A temperature- and time-controlled supply chain for products (e.g., refrigerated products typically have a temperature storage range of 2 °C to 8 °C). (TR58)

  • Comparative Transfer

    Transfer of a method that involves the analysis of a predetermined number of samples of the same lot by both the sending and the receiving unit. (TR 57-2)

  • Compressor

    Components used to pump refrigerant through the active temperature-controlled system. (TR64)

  • Computerized System

    Collective application software, data and hardware platform that provides functionality, control and data to a user or other system. (TR48)

  • Condenser

    Component that removes the heat absorbed by the refrigerant from the compressor and temperature- controlled area. (TR64)

  • Confidence Interval

    An interval estimate (range of values) of a population parameter, calculated from a random sample of the underlying population. (TR57)

    Interval estimate (range of values) of a population parameter calculated from a random sample of the underlying population that represents the likely range in which the true value of the parameter resides. (TR57-2)

  • Conformance Batches/Lots

    A pre-determined number of production lots, typically three, that represent the process and are evaluated to demonstrate consistency. [Synonyms: validation, consistency, demonstration lots, qualification lots] (TR14) (TR42)

  • Controlled Environmental Space (CES)

    An area that is controlled by regulating temperature. (TR64)

  • Correlation Coefficient ( r )

    A measure of covariation, the square root of the coefficient of determination. (TR57)

  • Corruption (Data) (FFIEC)

    Errors in computer data that occur during writing, reading, storage, transmission, or processing, which introduce unintended changes to the original data.(TR80)

  • Co-Validation

    Sending and receiving laboratories participate in the AMV study execution. (TR57)

  • Critical

    Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the drug substance meets its specification. (TR38)

  • Critical Control Point

    A step at which control can be applied and that is essential to prevent or eliminate a pharmaceutical quality hazard or reduce it to an acceptable level. (TR54-4) (TR61)

  • Critical Process (CP)

    A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.

  • Critical Process Parameter (CPP) or Critical Operational Parameter

    A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (TR54) (TR54-4) (TR56) (TR54-5) (TR60-2) (TR5 6) (TR 81)

  • Critical Quality Attribute (CQA)

    A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. (TR14)(TR54)(TR54-4)(TR57)(TR57-2)(TR60)(TR01)

    Product attributes that affect product safety, identity, strength, quality and purity.(TR15)

    Attributes that describe a parameter or item that must be controlled within predetermined criteria to ensure that the medicinal product meets its specifications .(TR39)

    A defining characteristic of the product, including purity, strength, identity and safety.(TR44)

    A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.(TR74)(TR 54-5)(TR81)

    A physical, chemical, biological or microbio­logical property or characteristic that should be within an appropriate limit, range, or distribu­tion to ensure the desired product quality, as de­fined in ICH Quality Guidance Q8. (TR56)

    A physical, chemical, biological, or microbio­logical property or characteristic that should be within an appropriate limit, range, or distribu­tion to ensure the desired product quality. (TR60-2)

  • Critical Reagent

    A component of the test method that may have a substantial impact on the consistency and reliability of method performance. Features of critical reagents include: 1. A reagent that requires qualification of each new batch prior to routine use in an analytical procedure, or 2. A material whose method performance characteristics may change over time, during handling, or from lot to lot. 3. An analytical reagent that may be purchased only from a single vendor. Reagent Examples: antibodies or enzymes that require titration prior to use, tissue culture treated plates when only one vendor’s plates give acceptable results for a bioassay, growth factors for bioassay cells, conjugated proteins that require custom preparations, or reference or system suitability standards. (TR57)

    Function related: assay reagents that have been shown through development and/or robustness studies to have the potential to generate measurable differences that can significantly affect assay performance, such as sensitivity, specificity, and precision. (TR57-2)

  • Criticality

    A classification of an item (e.g., process, equipment, parameter) that expresses the significance given to the impact of that item, and should therefore be controlled or monitored to ensure product quality, safety or efficacy. (TR54)

    A classification of an item (e.g., product, process, equipment, parameter) that expresses the significance given to the impact of that item, and should therefore be controlled or monitored to ensure product quality, safety or efficacy. (TR68)

  • Crj:CD

    The International Genetic Standardization System designator for Sprague Dawley (SD) rats. The SD (Crj:CD) is a general multipurpose rat model, used for safety and efficacy testing, aging, nutrition, diet-induced obesity, oncology. (TR55)

  • Cryopreservation

    A process where cells, viruses or whole tissues are preserved by cooling to low sub-zero temperatures, typically -1960C. (TR47)

  • Current Good Manufacturing Practices (CGMPs)

    Practices and systems that are required to be followed for pharmaceutical manufacturing to ensure that the products produced meet specific requirements for identity, strength, quality, and purity. (TR54)

    Refers to the Current Good Manufacturing Practice regulations enforced by the FDA and as described in the ICH guidance (ICH Q7 and WHO GMP, for API manufacturing). Current GMP provides for systems that assure proper design, monitoring, and control of manufactur­ing processes and facilities. Adherence to cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. (TR56)

  • Cycle Development

    A series of activities performed for the purpose of defining or confirming the cycle parameters (e.g., time, temperature, pressure) necessary to ensure sanitization or sterilization. (TR61)

  • Cycle Phases

    A discrete series of sterilizer process steps (such as, heat-up, exposure and cool-down) performed sequentially that represent a complete sterilization cycle. (TR48)

  • Darcy Permeability

    The constant of proportionality of the material as defined by Darcy’s Law. (TR45)

  • Darcy’s Law

    Darcy’s Law states that the volumetric flow rate Q of liquid through a specimen of porous material is proportional to the hydrostatic pressure difference ∆p across the specimen, inversely proportional to the length L of the specimen and proportional to the cross-sectional area A. Darcy’s Law is expressed as Q = kA ∆p/L. (TR45)

  • Data (MHRA)

    Facts, figures and statistics collected together for reference or analysis. All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, that are generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity.(TR80)

  • Data (WHO)

    Data means all original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of this data, which are generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity. Data should be accurately recorded by permanent means at the time of the activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails, photographs, microfilm or microfiche, audio- or video-files or any other media whereby information related to GXP activities is recorded.(TR80)

  • Data Integrity (FDA)

    Refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).(TR80)

  • Data Integrity (MHRA)

    The degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.(TR80)

  • Data Integrity (WHO)

    The degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.(TR80)

  • Data Lifecycle (MHRA)

    All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention, archive/retrieval and destruction.(TR80)

  • Data Lifecycle (WHO)

    All phases of the process by which data is created, processed, reviewed, analyzed and reported, transferred, stored and retrieved and monitored until retirement or disposal. There should be a planned approach to assessing, monitoring and managing the data and the risks to those data in a manner commensurate with potential impact on patient safety, product quality and/or the reliability of the decisions made throughout all phases of the data life cycle. (TR80)

  • Decision Maker(s)

    Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.(TR54) (TR54-2)

  • Decommissioning

    A planned and orderly removal of a facility, operation or system from use. (TR48)

    The process of retiring equipment/systems/facili­ties from production use. (TR54-5)

  • Defect

    (1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51)

    (2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)

  • Defect (ISO def.)

    The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR76)

  • Design of Experiments (DOE)

    A method for carrying out carefully planned experiments on a process. Usually, DoE involves a series of experiments that initially involves evaluating many variables and then focuses on a few critical ones. (TR54-4)

    A structured, organized method for determining the relationship between factors affecting an assay and output of that assay. (TR57) (TR57-2) (TR74)

  • Development Reports

    Documentation and description of work done during the early phases of development. The goal is to document information about the way the process works and to document why key choices were made in selecting the specifics of the process (e.g., flow rate or temperature). These documents can serve as a reference during investigations of discrepancies and during the design of specific Validation and characterization studies.(TR14) (TR 42)

  • Deviation

    Departure or digression from set parameters. (TR58)

  • Distribution Thermocouple

    Device placed in the interior of the controlled environment space (CES) to measure air temperature but is not placed in the product (see penetration thermocouple). (TR64)

  • Documentation

    See Development Reports , Process Characterization Report , Process Validation Protocol, or Process Validation Report (TR14) (TR42)

  • Drug Development

    A general term used to define the entire process of bringing a new drug to the Market. It includes drug discovery, process and product development, pre-clinical research (microorganisms/cell culture/animals) and Clinical trials (on humans). (TR56)

  • Drug Substance (DS)

    The active ingredient that is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients, including buffers and other components. [Synonyms: bulk drug substance, bulk material, active pharmaceutical ingredient (API)] (TR14) (TR57) (TR74) (TR60)

    Active pharmaceutical ingredient in a drug product that is responsible for that product’s therapeutic activity.(TR67) (TR82) 

    See Active Pharmaceutical Ingredient (API). (TR56)

  • Dynamic Light Scattering (DLS)

    A technique used to measure the size and size distribution of particles. Particles suspended in a solution will cause scattering of light and the extent of the scattering is related to the size and shape of the particles. (TR47)

  • Dynamic Record Format (FDA)

    The record format allows interaction between the user and the record content.(TR80)

  • Dynamic Record Format (MHRA)

    An electronic record which the user reviewer can interact with.(TR80)

  • Dynamic Record Format (WHO)

    Records, such as electronic records, that allow for an interactive relationship between the user and the record content.(TR80)

  • Early Phase (Generally used to indicate the following clinical study activities)

    Generally used to indicate the following clinical study activities: Microdosing Studies, Phase 1 Trials, Phase 2 Trials, and Phase 3 Trials. See any of the following studies for more information. (TR56)

  • Early Phase (Generally used to indicate the following clinical study activities) --Microdosing Studies

    Studies designed to speed up the development of promising drugs by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. May include the administration of single sub therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body). A microdosing study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. (TR56)

  • Early Phase (Generally used to indicate the following clinical study activities)--Phase 1 Trials

    Phase 1 trials are the first stage of testing in human subjects. Often, a small (20-100) group of healthy volunteers will be selected. For life-threatening indications such as oncology, these can be patients that have the target disease but may not yet be the ideal target population. This Phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. (TR56)

  • Early Phase (Generally used to indicate the following clinical study activities)--Phase 2 Trials

    Once the initial safety of the study drug has been confirmed in Phase 1 trials, Phase 2 trials are performed on larger groups (20-300) are designed to assess efficacy, as well as to continue safety assessments in a large group of volunteers and patients. Phase 2a is specifically designed to assess dosing requirements (how much drug should be given). Phase 2b trials are specifically designed to study efficacy (how well the drug works at the prescribed dose(s). (TR56)

  • Early Phase (Generally used to indicate the following clinical study activities)--Phase 3 Trials

    Final clinical stage Phase 3 trials are designed to demonstrate the potential advantages of the new therapy over other therapies already on the market; safety and efficacy of the new therapy are studies over a long period of time and many more patients (1,000-3,000) are enrolled into the study with less restrictive eligibility criteria; phase 3 studies are intended to help scientists identify rarer side effects of treatment and prepare for a broader application of the product; phase 3 trials enroll patients to verify efficacy and monitor adverse reactions during longer-term use. (TR56)

  • Electronic Record

    A record used for GMP purposes or for regulatory submission that is stored electronically for the purposes of reproduction, retrieval or archival. (TR48)

  • Enabler

    A tool or process which provides the means to achieve an objective (ICH Q10). (TR54)

  • End-Of-Production Cells (EOPC)

    Cells cultured (under conditions comparable to those used in production) from the MCB or WCB to a passage level or population doubling level comparable to or beyond the highest level reached in production. Note: The ICH term is: “Cells at Limit of invitro Cell Age Used for Production”.
    Note: The term as defined in ICH Guidance Q5 D is “Cells at Limit of in vitro Cell Age Used for Production”; also abbreviated as EPC. (TR56)

  • Equivalence

    See Comparability. (TR38)

    A comparison with the primary objective of showing that the results from two methods differ by an amount which has negligible impact on fitness for use. This is usually demonstrated by showing that the true difference is likely to lie between a lower and an upper equivalence margin of acceptance differences. (TR57)

  • Equivalence Margin

    The largest difference between the results from two methods that is considered as being scientifically and statistically acceptable. (TR57)

  • Equivalence Test

    Test of conformance to interval-based target acceptance criteria; differs from most common statistical tests in the nature of the statistical hypothesis. In equivalence testing, the alternative hypothesis is that the difference is sufficiently small that no important difference exists. A common statistical procedure used for equivalence testing is the two one-sided T-test. (TR57-2)

  • Equivalence/Comparative Testing

    A measure of how similar the test results are when compared with the existing method. (TR33)

  • Error

    Deviation from expected value. Error may be random or systematic. (TR57)

  • Event Tree Analysis (ETA)

    A systematic technique that employs forward logic to construct a graphical representation of consequences from an initiating event. (TR54)

  • Excipient

    A component of a drug formulation that has no active pharmacologic function. Excipients are commonly used in drug formulations as modulators of pH or osmolality for parenteral administration and as stabilizers for APIs. (TR54-4)

    An ingredient added intentionally to the drug substance that should not have pharmacological properties in the quantity used. (TR57)

    Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes. (TR67)

  • Exclusivity

    The capacity of an assay not to detect microorganisms closely related to a target microorganism. (TR33)

  • Extemporaneous Preparation (EP)

    A type of compounding whereby a drug or combination of drugs and/or excipients is prepared under the supervision of a pharmacist to create a customized medication dosage form in accordance with a clinical protocol. (TR63)

  • Factor

    Independent variables that may influence assay outcome. (May be modified with confounded, crossed, fixed, interaction, level, modifying, nested, random). (TR57) (TR57-2)

  • False Negative

    A test result that is erroneously classified in a negative category (e.g., the absence of a viable microbial detection result when viable microorganisms are present). (TR33)

  • False Positive

    A test result that is erroneously classified in a positive category (e.g., a viable microbial detection result when viable microorganisms are not present). (TR33)

  • Fed-Batch Filtration Process

    A modification of the batch filtration process in which a separate (typically larger) reservoir feeds a smaller recycle tank. The retentate stream is returned to the recycle tank. (TR15)

  • Formal Experimental Design (Synonym – Design of Experiments)

    A structured, organized method for determining the relationship between factors affecting a process and the output of that process. (TR60)

  • Formative Usability Evaluation

    Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)

  • Formulation

    A listing of the ingredients and composition of the dosage form. (TR38) The percent composition of ingredients in a product. (TR67)

  • Freeze-Thaw

    A study designed to determine the effect of repeated freezing (typically to -20 °C), and thawing back to labeled storage conditions (typically +5 °C for refrigerated products, and +25 °C for temperature products). Freeze-thaw studies are designed to evaluate the impact of short-term excursions where product may be exposed to sub-zero temperatures, followed by standard shipping conditions. (TR53)

  • Glide Force

    Force in Newtons (N) required for plunger movement within an empty syringe. (TR73)

  • GXP (WHO)

    Acronym for the good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and postmarket activities for regulated pharmaceuticals, biologicals, and medical devices, such as good laboratory practices, good clinical practices, good manufacturing practices, good pharmacovigilance practices and good distribution practices.(TR80)

  • Historical Data

    For purposes of this guidance, data on impurities or physical attributes from three or more consecutive, representative pre-modification batches. (TR38)

  • Human Factors

    A science discipline that examines human psychological, social, physical, and biological characteristics to evaluate the design, operation, or use of products or systems for optimizing human performance, health, safety, and/or habitability. [Synonym: Ergonomics] (TR62)(TR80)

  • Hybrid Approach (WHO)

    The use of a computerized system in which there is a combination of original electronic records and paper records that comprise the total record set that should be reviewed and retained.(TR80)

  • Identification

    Use of an analytical procedure to determine the chemical and biochemical identity of a material. (TR57)

  • Identity Test

    A technique used to determine or confirm the identity of an organism (virus, bacteria, cells). (TR47)

  • Impurity

    Any component present in the drug substance or drug product that is not the desired product, a product-related substance, or excipient including buffer components. It may be either processor product-related. (TR14) (TR57) (TR74)

  • Impurity Profile

    A description of the identified and unidentified impurities present in a drug substance (ICH A3A). (TR38)

  • Intermodal Container

    A shipping container used to ship cargo through more than one of the four traditional modes of transportation (road, air, ocean, and rail). (TR64)

  • Investigational Medicinal Product

    A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. (TR29)

  • Justification

    Reports containing scientific data and expert professional judgment to substantiate decisions. (TR38)

  • Key Attributes

    A subset of the characteristics of the drug which are determined to be most important to quality. (TR63)

  • Knowledge Management

    Systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components (ICH Q10). (TR54) (TR68) (TR54-5)

  • Lifecycle

    All phases in the life of a product from the initial development through marketing until the product’s discontinuation. (TR54) (TR60)

    All phases in the life of a product, from the initial development through marketing until the prod­uct is discontinued. (TR60-2)

  • Manual Cleaning

    A cleaning procedure requiring operator-performed critical steps (e.g., scrubbing with a brush or rinsing with a hose). (TR70)

  • Manual Integration

    Process used by a person to modify the integration of peak area by modifying the baseline, splitting peaks, or dropping a baseline as assigned by the chromatography software to overrule the pre-established integration parameters within the chromatographic software.(TR80)

  • Manufacturing

    The production, packing, testing, storage, release and distribution of drugs or medical devices for use in humans or animals where the manufacturing is indented to produce doses, typically in significant numbers, for an undefined population of future patients or clinical trial subjects. (TR63)

    All operations including purchasing and receipt of materials to production, packaging, labelling, quality control, release, storage, distribution of components and the related controls. (TR 76)

  • Market Package

    The package presentation intended for the end user (e.g., bottle + cap liner + screw cap + label + dose cup + carton; may contain multiple units of product), but not including packaging used solely for transportation (e.g., corrugated boxes or insulated containers). (TR39)

  • Mass Spectroscopy

    An analytical test method for identifying the chemical composition of a sample by separating its gaseous component ions according to their mass and charge. (TR26)

  • Master Cell Bank (MCB)

    The MCB represents a collection of cells of uniform composition derived from a single source prepared under defined culture conditions. (TR 54-4)

    The MCB represents a collection of cells of uni­form composition derived from a single source pre­pared under defined culture conditions, aliquoted into multiple vials, cryopreserved and stored in the vapor phase of liquid nitrogen. (TR 83)

  • Master Cell Bank (mCb)/Master Virus Bank (mVb)

    A stock of cells or virus used to produce the Working Cell Bank or the Working Virus Bank. Cell/virus banking is used to enhance biological consistency. (TR47)

  • Master Seed Stock

    Reference culture of a microorganism derived from an authenticated source such as American Type Culture Collection (ATCC) and used to produce working seed lots. (TR51)

  • Matrix

    The combination of materials (e.g., excipients, stabilizer components, etc.) which are components together with the measured analyte. (TR57)

  • Matrix Effect

    The direct or indirect alteration or interference in response due to the presence of additional sample components due to sample preparation (for analysis) or other interfering substances in the sample (product related excipients or residuals). (TR57) (TR57-2)

  • Metadata (FDA)

    The contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.(TR80)

  • Metadata (MHRA)

    Metadata is data that describe the attributes of other data and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data. It also permits data to be attributable to an individual (or if automatically generated, to the original data source).(TR80)

  • Method Capability

    The resulting acceptable uncertainty of results to achieve the required capability to detect, quantify, and/or discriminate the analyte at levels that is relevant to the intended use. (TR57)

  • Method Development

    A process that involves the selection, optimization, and qualification of a physical/chemical, biological, molecular, or microbiological test procedure. (TR57)

  • Method Lifecycle

    All stages in the life of a method, from the initial development through marketing, until the method’s discontinuation. (TR57-2)

  • Method Operating Space

    Proven acceptable ranges of a method based on knowledge of the effects of critical instrument and procedural parameters on method performance within the design space. (TR57-2)

  • Method Parameter

    Any factor or method operational step that can be varied continuously (e.g., flow rate) or specified at controllable unique levels (e.g., Gas Chromatograph liner type).

    Source
  • Method Qualification

    Formal or informal study performed to assess initial method performance prior to full ICH Q2 (R1) validation; assessment activity that cul­minates in a scientifically sound method that has an acceptable level of performance and is docu­mented to be suitable for its intended use. (TR56)

    Experimental studies performed to confirm the inherent performance capabilities of a test method for the material being analyzed and the intended use of the method. Method qualification can be performed during early development phases, prior to method validation. Specific method qualification characteristics (e.g., accuracy, specificity) should be confirmed based on the intended use of the analytical method and the relevant risk(s). (TR57)

  • Method Validation

    A formal, archived demonstration of the analyti­cal capacity of an assay that provides justification for use of the assay for an intended purpose. (TR56)

    A formal, archived demonstration of the analytical capacity of an assay that provides justification for use of the assay for an intended purpose. Validations are conducted prospectively according to a written, approved plan that states acceptance criteria. (TR57) (TR57-2)

  • Method, Qualitative

    An analytical procedure, based on the characteristics of a material that yields results that are not amenable to reliable enumeration. (TR57)

  • Method, Quantitative

    An analytical procedure that yields numerical results compared to quantitative specification(s). (TR57)

  • Microbial By-Products

    An analytical procedure that yields numerical results compared to quantitative specification(s). (TR57)

    Organic compounds produced by microorganisms during metabolism and released into the bulk-phase environment. (TR69)

  • Minimum Acceptable Cycle (MAC)

    The minimum cycle conditions (in terms of delivered minimum lethality or minimum time and temperature) that would be considered acceptable. (TR01) (TR61)

  • Minimum Load

    The minimum quantity or mass of items permitted in a validated depyrogenation or sterilization load. (TR01) (TR3) (TR30) (TR48)

  • Mixed Load

    A load that contains multiple item item types representing various sterilization challenges. For example, some load items may have air removal challenges, while others pose a challenge due to their mass. (TR01)

  • Nonclinical Laboratory Study

    For this report, nonclinical laboratory study means in vivo or in vitro experiments, in which test arti­cles are studied prospectively in test systems under laboratory conditions in order to determine their safety. The definition does not include: studies us­ing human subjects or clinical studies, field trials in animals, or any basic exploratory studies carried out to determine whether a test article has any po­tential utility or to determine physical or chemical characteristics as described in ICH S6 and 21 CFR Part 58 (GLP).
    Note: Also referred to as Preclinical, Toxicity or “Tox” studies. (TR56)

  • Noninferiority

    A comparison with the primary objective of showing that the result from one method is not inferior to the method being compared. This is usually demonstrated by showing that the true difference is likely to lie above the lower equivalence margin. (TR57)

  • Normal Operating Range (NOR)

    A defined range, within (or equal to) the Proven Acceptable Range, specified in the manufacturing instructions as the target and range at which a process parameter is controlled, while producing unit operation material or final product meeting release criteria and CQAs. (TR60) (TR60-2)

  • Operating Parameters

    Values (e.g., time, temperature, pressure) that are controlled and/or measured that collectively define each phase of a sterilization cycle (e.g., heat-up, exposure, cool-down). (TR01) (TR3) (TR48) (TR61)

    An input variable (e.g., time, temperature, pressure) or condition of the manufacturing process that can be directly controlled. (Synonym: process parameter) (TR30) (TR51)

  • Operating Parameters (Critical Parameters)

    Values that are controlled and/or measured and are linked to safety and efficacy of a product or the process. Failure to meet a critical parameter should result in rejection of the load. (TR01) (TR3) (TR48) (TR51)

  • Operating Parameters (Key Parameters)

    Values that are controlled and/or measured and are used to assure the ongoing “state of control” and consistency of runs. Failure to meet a key process parameter should result in an investigation with a documented rationale for the disposition of the load. (TR01) (TR3) (TR51) (TR48)

    Values that are controlled and/or measured and are used to assure the ongoing “state of control” of steam in place cycles. Failure to meet a key process parameter should result in an investigation. (TR61)

  • Operating Principle

    Rules or concepts governing the operation of the system. (TR38)

  • Operational Qualification (OQ)

    Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR14) (TR61) (TR64) (TR72)

    The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR54-5)

  • Opportunity Costs

    This is defined as the value of the next-best choice available when choosing between several mutually exclusive choices (e.g., the decision to expand a facility may result in losing the opportunity to invest the maintenance funds in the financial markets). Opportunity costs are often excluded from estimates of fixed operation costs because they can be difficult for comparative analyses in the overall decision process. (TR66)

  • Optical Density (OD)

    A unitless measure of the absorption of light of a given wavelength in media of a given path length. (TR41)

  • Original Record (MHRA)

    The first or source capture of data or information, e.g., original paper record of manual observation or electronic raw data file from a computerised system, and all subsequent data required to fully reconstruct the conduct of the GXP activity. Original records can be static or dynamic.(TR80)

  • Parameters

    (TR14)

  • Parameters (Critical Operational Parameter)

    An input process parameter that should be controlled within a meaningful, narrow operating range to ensure that API quality attributes meet their specifications. Although parameters with wide operating ranges may also impact product quality, they are generally easily controlled and not as likely to result in excursions that affect quality and are therefore low risk. [Synonym: critical process parameter (CPP)] (TR14)

  • Parameters (Critical Process Parameter (CPP; Synonym – Critical Operational Parameter))

    A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (TR60)

    A process parameter whose variability has an impact on critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (TR74)

  • Parameters (Key Operational Parameter)

    An input process parameter that should be carefully controlled within a narrow range and is essential for process performance. A key operational parameter does not affect critical product quality attributes. If the acceptable range is exceeded it may affect the process (e.g., yield, duration) but not product quality. (TR14)

  • Parameters (Key Process Parameter (KPP; Synonym – Key Operational Parameter)

    An input process parameter that should be carefully controlled within a narrow range and is essential for process performance. A key process parameter does not affect product quality attributes. If the acceptable range is exceeded, it may affect the process (e.g. yield, duration) but not product quality. (TR60)

  • Parameters (Non-Critical Operational Parameter)

    All input process parameters that fall outside the definition for critical operational parameter are non-critical. Non-critical operational parameters are divided into key and non-key operational parameters. [For further explanation, see Sub-section 3.3.6 (TR14)

  • Parameters (Non-Key Operational Parameter)

    An input process parameter that has been demonstrated to be easily controlled or has a wide acceptable limit. Non-key operational parameters may have an impact on drug substance quality or process performance if acceptable limits are exceeded. (TR14)

  • Parameters (Non-Key Process Parameter (Non- KPP; Synonym – Non-key Operational Parameter) )

    An input parameter that has been demonstrated to be easily controlled or has a wide acceptable limit. Non-key operational parameters may have an impact on quality or process performance if acceptable limits are exceeded. (TR60)

  • Parameters (Operational Parameter)

    An input variable or condition of the manufacturing process that can be directly controlled in the process. Typically, these parameters are physical or chemical (e.g., temperature, process time, column flow rate, column wash volume, reagent concentration, or buffer pH). [Synonym: process parameter] (TR14)

  • Parameters (Performance Parameter)

    An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. [Synonym: performance attributes] (TR14)

  • Parameters (Process Parameter (Synonym – Operational Parameter)

    An input variable or condition of the manufacturing process that can be directly controlled in the process. Typically, these parameters are physical or chemical (e.g. temperature, process time, column flow rate, column wash volume, reagent concentration, or buffer pH). (TR60)

  • Peak Asymmetry

    A mathematical measure in a chromatogram of the HETP peak shape that is determined by measuring the front and back halves of a peak and is reflective of column efficiency. The ideal chromatogram contains a peak of perfect symmetry. (TR14)

  • Peak Intergration

    Process used to by a chromatographic system to determine the peak area (based on height and width) and obtain the quantitation of the peak of interest. The measurement is based on the integral technique of splitting the peak into a large number of rectangles, which are then summed to provide an estimate of the total area under the peak. (TR80)

  • Performance Attribute

    An output variable or outcome that cannot be directly controlled but is a measurable indicator that the process performed as expected (e.g., bioburden, load monitor). [Synonym: performance parameter] (TR30)

  • Performance Qualification (PQ)

    Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications. (TR3) (TR14) (TR45) (TR42) (TR48) (TR61) (TR64)

    Transport tests of product or representative product that is conducted during actual transportation or distribution. (TR39)

    Documented evidence that provides a high de­gree of assurance that the equipment and/or system functions accurately and consistently according to predetermined specifications in its operating environment. (TR54-5)

  • Polymerase Chain Reaction (PCR)

    A technique widely used in molecular biology in which a DNA polymerase is used to amplify a piece of DNA by in vitro enzymatic replication. As PCR progresses, the DNA thus generated is itself used as a template for replication. This sets in motion a chain reaction in which the DNA template is exponentially amplified. This technique may be used to quantify virus. (TR41) (TR47)

  • Precision

    The degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of the same suspension of microorganisms and using different suspensions across the range of the test. Also known as repeatability. (TR33)

    The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision, and reproducibility. It is usually expressed as the variance, standard deviation, or coefficient of variation of a series of measurements. (TR57)

  • Precision, Intermediate

    The closeness of agreement between a series of measurements obtained within laboratory variations (e.g., different days, different analysts, different equipment). (TR57)

  • Precision, Repeatability

    The closeness of agreement between a series of measurements obtained under ideal conditions (e.g., same day, analyst, and instrument). (TR57)

  • Precision, Reproducibility

    The closeness of agreement between a series of measurements for the same sample obtained among different laboratories. (TR57)

  • Pressure Shock

    An unanticipated rapid increase in fluid flow. [Synonym: Hydraulic Shock] (TR45)

  • Pressure Shock (Backward Pressure Shock)

    Rapid backward fluid flow that may result in filter rupture. (TR45)

  • Pressure Shock (Forward Pressure Shock)

    Rapid increase in forward fluid flow that may dislodge particulates. (TR45)

  • Primer

    A short synthetic single-stranded nucleic acid complementary to a specific sequence of a target gene, DNA or RNA. It usually serves to initiate the de novo synthesis of nucleic acid from a template. (TR50)

  • Process

    A series of operations and/or actions used to produce a desired result. (TR38)

  • Process Analytical Technology (PAT)

    A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. (TR60) (TR60-2)

  • Process Characterization

    Studies performed during process development to establish acceptable ranges for key input vari­ables and critical operational parameters that de­fine the process design space. (TR56)

  • Process Characterization of Viral Clearance

    Viral clearance studies in which nonspecific model viruses are used to assess the general virus clearance capacity of the manufacturing process to remove and/or inactivate viruses. (TR41)

  • Process Characterization Report

    A report that includes results from a study characterizing the performance of a unit operation and/or operations conducted in a process characterization study. The report describes process characteristics, the operational parameters (e.g., critical, key, and non-key) and their acceptable ranges (limits), and acceptance criteria for Validation

    protocols. (TR14) (TR42)

  • Process Evaluation Studies of Viral Clearance

    Viral clearance studies in which relevant and/or specific “model” viruses are used to determine the ability of the manufacturing process to remove and/or inactivate these viruses. (TR41)

  • Process Flow Diagram (PFD)

    A document, typically prepared by R&D, that describes the intended manufacturing process. The PFD includes all relevant information for the operation of the manufacturing process, organized by unit operation. The PFD serves as the source document for the initial development of the master production records and is locked down once development has determined that the process can be controlled. (TR65)

  • Process Parameter (PP)

    A process variable, process value or process parameter is the current status of a process under control. An example of this would be the temperature of a furnace. (TR54-4)

  • Process Performance Qualification

    Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment. (TR01)

  • Process Performance Qualification (PPQ)

    The second element of the Process Qualification. It includes a combination of the actual facility, utilities, equipment, and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected. Batches prepared are also called Conformance batches or PPQ batches. (TR60) (TR54-5)

    Confirming that the manufacturing process, as designed, is capable of reproducible commercial manufacturing. (TR60-2)

  • Process Qualification

    Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment. (TR3)

    Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing. (TR54) (TR60) (TR54-5)

  • Process Robustness

    Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact on quality. (TR60)

  • Process Simulation (with microbiological growth media)

    Method of evaluating an aseptic process using a microbial growth medium employing methods which closely approximate those used for sterile materials. (TR28)

  • Process Simulation (without microbiological growth media)

    Method of evaluating an aseptic process employing methods which closely approximate those used for sterile materials using an appropriate material. (TR28)

  • Process Step

    An event that is a necessary part of the manufacturing procedure or unit operation. (TR44)

  • Process Validation

    The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API (drug substance) meeting its predetermined specifications and quality attributes. (TR14) (TR42)

    Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. (TR44)

    The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products. (TR54) (TR57) (TR74) 

    The collection and evaluation of data, from the pro­cess design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.
    The documented evidence that the process, op­erated within established parameters, can per­form effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes, as described in EMA, EU GMP, Part 1, Annex 15, drug/me­dicinal product. (TR56)

    EMA: The documented evidence that the process, op­erated within established parameters, can per­form effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
    US FDA: The collection and evaluation of data, from the process design stage through commercial pro­duction, which establishes scientific evidence that a process is capable of consistently deliver­ing quality products. (TR60-2)

  • Process Validation (EMA)

    The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. (TR60) (TR54-5)

  • Process Validation (US FDA)

    The collection and evaluation of data from the process design stage to commercial production,, which establishes scientific evidence that a process is capable of consistently delivering quality products. (TR60) (TR54-5)

  • Process Validation Master Plan (PVMP)

    A document that defines the process validation scope and rationale and that contains the list of process validation studies to be performed (Synonym: Validation Master Plan). (TR42) (TR60)

    The plan that documents rationale for the approach to validation and lists all systems and their validation status. (Note: The VMP can be used to document the rationale for number of monitors and revalidation frequency, as well as other system justifications). (TR52)

  • Process Validation Protocol

    A written plan pre-approved by the quality unit that specifies critical steps, controls, and measurements. The process validation protocol states how validation will be conducted, identifying sampling, assays, specific acceptance criteria, production equipment, and operating ranges. Results obtained for each study described in the protocol should be evaluated in an associated process Validation report. (TR14) (TR42)

  • Process Validation Report

    A report approved by the quality unit that summarizes specific tests performed, compares the test results with the protocol acceptance criteria, and addresses deviations encountered during the study. (TR14) (TR42)

  • Processing Time

    The duration of time for a phase of a manufacturing unit operation or the entire operation. (TR41)

  • Product Changeover

    Procedural steps taken for switching from the manufacturing of one product to another product. (TR29)

  • Product Lifecycle

    All phases in the life of a product from the initial development through marketing until the product’s discontinuation (ICH Q8[R2]. (TR54) (TR54-5)

  • Prospective Process Validation

    Validation conducted prior to the distribution of either a new product or a product made under a revised manufacturing process where the revisions may affect the product’s characteristics. (TR42) (TR74)

  • Protocol

    A predefined, written procedural method for the design and implementation of experiments to define and document the methodology and criteria required to assess the capability of a temperature-controlled system to achieve the desired result. (TR64)

  • Protocol Deviation

    A deviation that occurs when a result is unexpected (i.e., fails to meet the predetermined acceptance criteria) or a procedure in the protocol cannot be executed as written (e.g., when a challenge is conducted using a methodology other than that described in the protocol or a process/ piece of test equipment fails). (TR64)

  • Protocol Summary Report

    A report generated at the completion of the activities identified in an individual validation protocol that summarizes deviations and conclusions. (TR64)

  • Proven Acceptable Range (PAR)

    A characterized range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria. (TR60)  (TR60-2)

  • Qualification

    Documented testing that demonstrates with a high degree of assurance that a specific process will meet its pre-determined acceptance criteria. (TR39) (TR58) (TR64)

  • Qualification Documentation

    Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). (TR58)

  • Qualified Assay

    An assay that is not fully validated but is documented to be suitable for its intended use, including sample collection and handling procedures. Such an assay should be demonstrated to be accurate, precise, linear within the range of use, and show no interference from process stream components (i.e., spike recovery). (TR42)

  • Qualified Person (QP)

    An individual as defined in the European Union pharmaceutical regulation as described in Direc­tive 2001/83/EC that has the legal responsibil­ity for batch release of medicinal products.
    Note: See also EU GMP Annex 16, Certification by a Qualified Person and Batch Release. (TR56)

  • Quality

    The degree to which a set of inherent properties of a product, system or process fulfills requirements. The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength and purity. (TR44) (TR57)

    The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength and purity. (TR60) (TR60-2)

  • Quality Assurance (QA)

    The sum total of the organized arrangements made with the object of ensuring that all materi­als are of the quality required for their intended use and that quality system is maintained. (TR56)

  • Quality Attribute

    A molecular or product characteristic that is selected for its ability to help indicate the quality of the product, such as identity, purity, potency stability and safety. (TR57) (TR57-2)

    A molecular or product characteristic that is selected for its ability to indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency, and stability of the product, and safety with respect to adventi­tious agents. Specifications measure a selected subset of the quality attributes. (TR60-2)

  • Quality by Design (QbD)

    QbD is utilization of a more systematic and scientific approach to development for enhanced process understanding, so that better controls may be implemented. (TR54-4)

    A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (TR60)(TR80) 

    Framework enabling the attainment of the desired state; systematic approach to development that begins with predefined objectives and that emphasizes product and process understanding and process control based on sound science and quality risk management. (TR57-2)

  • Quality Management (QM)

    System for Transport Service Providers:A QM system that may cover topics such as, but not limited to:(TR39) GMP/GDP relevant processes identified and described in standard procedures, a procedure to identify the main functions of individuals, roles and responsibilities, and contact information of relevant individuals in the case of a deviation, an adequate change control system and an adequate deviation management system, including procedures for corrective actions

  • Quality Risk Management (QRM)

    A systematic process for the assessment, control, communication, and review of risk to the quality of the drug product across the product lifecycle.(TR43)(TR54-2)(TR54-3)(TR57)(TR67)(TR68)

    Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).(TR58)

    A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.(TR 54-5)(TR 76)

  • Quality Specification System

    A system that outlines the nonconformities, classifications and AQL’s. (TR43) (TR 76)

  • Quality System

    Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. (TR30) (TR44) 

    The sum of all aspects of a system that imple­ments quality policy and ensures that quality ob­jectives are met. (TR54-5)

  • Quality Target Product Profile (QTPP)

    A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. (TR60) (TR54-4)(TR 81)

  • Quality Target Profile (QTP)

    A target product profile is a prospective and dynamic summary of the quality characteristics of a drug product that ideally will be achieved to ensure that the desired quality, and hence the safety and efficacy, of a drug product is realized. The target product profile forms the basis of design for the development of the product (ICH Q8 [R2]). (TR54)

  • Quantitative PCR (Q-PCR or qPCR) or Real-time PCR

    PCR method in which specialized instruments and reagents are used to measure the amount of amplified DNA present after each round of DNA replication. Analysis of the data allows calculation of the amount of template DNA present in the test sample. The technique can be used to quantify virus or free nucleic acid. (TR47)

  • Range

    The interval between the upper and lower levels of microorganisms that have been demonstrated to be determined with accuracy, precision and linearity. (TR33)

    The range of an analytical procedure is the interval between the lower and upper quantitation limits. Within this range, a suitable performance level for precision, accuracy, and linearity can be demonstrated. (TR57)

  • Raw Data (FDA)

    Any laboratory worksheets, records, memoranda, notes, or exact copies thereof that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.(TR80)

  • Raw Data (MHRA)

    The original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in that state.(TR80)

  • Reagent

    For analytical procedures, any substance used in a reaction for the purpose of detecting, measuring, examining, or analyzing other substances. (TR57)

  • Receiving Unit (RU)

    Term for the internal or external recipient or site where the technology is being transferred to. (TR65)

  • Recovery

    The mass of desired solute in the final product solution (either permeate or retentate, depending on the process), divided by the mass of the desired solute in the initial feed solution, expressed as a percentage. [Synonym: yield] (TR15) (TR45) A measure of the amount of analyte carried through the entire sample preparation and assay procedure and expressed as a percentage of the nominal concentration. (TR57)

  • Recovery Medium

    A microbial growth medium that has been validated for the germination of spores and the growth of vegetative cells. Such a medium should be optimized for the growth and germination of injured cells or spores. (TR51)

  • Recovery Study

    A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR29) A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR49)

  • Reference Standard

    A characterized biological material developed to monitor the performance of an assay. For example, the standards for NAT assays may be nucleic acid templates such as plasmids, genomic DNA, cellular or in vitro synthesized RNA. (TR50) The defining characteristics of a reference standard are:
    1) it is stable;
    2) it performs similarly (e.g., on dilution) to test materials in the assay; and
    3) it is homogeneous. (TR57)

    A reference standard, or reference material, is a substance prepared for use as the standard in an assay, identification, or purity test. It should have a quality appropriate to its use. It is often characterized and evaluated for its intended purpose by additional procedures other than those used in routine testing. For new drug substance reference standards intended for use in assays, the impurities should be adequately identified and/or controlled, and purity should be measured by a quantitative procedure. (TR63)

  • Reference Strain

    A well characterized, widely accepted preparation of viable organisms that is used to validate a microbiological assay. (TR50)

  • Regeneration

    Operation performed to remove residual proteins, impurities, or contaminants from the resin. [Synonym: strip] (TR14)

  • Regression

    A mathematical model in which the response of a dependent variable is a function of change in an independent variable, such as is seen in a concentration-response curve. Regression may be linear (e.g., a straight line) or non-linear (e.g., four parameter logistic). (TR57)

  • Relative Accuracy

    Attribute determined after demonstration of precision, linearity, and specificity under deliberately varied conditions, such as across a range of sample dilutions in the presence of matrix interference. (TR57-2)

  • Relevant Virus

    A virus used in process evaluation studies that either is the identified virus, or of the same species as the virus known to or likely to contaminate the cell substrate or any other reagents or materials used in the production process. (TR41)

  • Repeatability

    The precision under the same operating conditions over a short interval of time. (TR57)

  • Replicates

    Independent preparations of a sample or standard that are subject to the same treatment conditions. (TR57)

  • Reporter Gene

    A coding sequence linked to a gene or promoter of interest. It is generally used to determine activation of the promoter or expression of the gene of interest in a cell or organism. (TR50)

  • Reprocessing

    Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. (TR74)

  • Reproducibility

    The precision among multiple laboratories (collaborative studies, usually applied to standardization of methodology). (TR57) The precision between laboratories, for example, through collaborative studies. (TR33)

  • Requalification

    Periodic confirmation to demonstrate that equipment performance has not changed from its qualified state. (TR3)

  • Reserve/Reference Samples

    An appropriately identified reserve sample that is representative of each lot of intermediate product and in each shipment of each active ingredient shall be retained (at least twice the quantity nec­essary for all tests required to determine whether the active ingredient meets its established specifi­cations; this is a regulatory Requirement). (TR56)

  • Residual Fit

    Signed difference between an observed value and the fitted value used to detect nonlinearity, unequal variances, and outliers. (TR57-2)

  • Residual Risk

    Risk remaining after risk control measures have been taken. (TR44) (TR58)

    Risk remaining after risk control measures have been implemented (derived from ISO 14971:2007). (TR54) (TR54-2)

    Risk remaining after risk control measures has been implemented. (TR54-5)

  • Residue

    Chemical or microbiological material remaining on equipment surfaces after a cleaning process. (TR29)

  • Restricted Access Barrier System (RABS)

    RABS are aseptic processing systems (ISO 5) intended to substantially reduce human borne contamination within the aseptic environment where sterile product, containers, closures and equipment are exposed by the use of separative devices and defined mechanical features and operating procedures. (TR22) (TR62)

    Aseptic processing systems (ISO 5) intended to substantially reduce human-borne contamination within the aseptic environment where sterile product, containers, closures, and equipment are exposed by the use of separative devices and defined mechanical features and operating procedures. (TR13)

  • Retain (Retention) Samples

    Intermediate and final and finished product samples that are stored for the intent of repeating any in-process or release analysis. Typically this is twice the amount of material that is required to perform these. (TR56)

  • Rework

    Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent). (TR74)

  • Robustness

    The measure of capacity to remain unaffected by small, but deliberate, variations in method parameters and provides an indication of its reliability during normal usage. (TR57) (TR33)

  • Routine Operational Cycle

    Parameters that are specified for ongoing sterilization operations. The operational cycle is typically controlled to produce additional lethality over the qualified minimum acceptable cycle in order to provide increased sterility assurance. (TR01) (TR61)

  • Routine Operational Process

    Parameters that are specified for ongoing operations. The operational process is typically controlled to produce additional lethality over the qualified minimum parameters (i.e., time and temperature) in order to provide increased sterility assurance. (TR3)

  • Ruggedness

    The degree of intermediate precision or reproducibility of test results obtained by assessing the same samples under a variety of normal test conditions. (TR33)

  • Screening Studies

    Studies used to select a particular type and grade of filter media. (TR45)

  • Secondary (Working, In-house) Reference Standard

    Substance of established quality and purity that is qualified against, and used instead of, the primary reference standard; typically used as a reference standard for routine laboratory analysis. (TR57-2)

  • Sending Unit (SU)

    Term for the internal or external source or originator site of the technology to be transferred. (TR65)

  • Senior Management

    Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site (TR54) (TR54-2)

  • Sensitivity

    Ability of a method to detect small changes in the quality attribute (e.g., changes in concentration or purity) being measured. (TR57-2)

  • Signal Detection Theory

    A means to quantify the ability to discern between signal and noise. According to the theory, there are a number of determiners of how a detecting system will detect a signal, and where its threshold levels will be. The theory can explain how changing the threshold will affect the ability to discern, often exposing how adapted the system is to the task, purpose or goal at which it is aimed. (TR55)

  • Similar

    Having a general likeness. (TR38)

  • Site Acceptance Testing

    The SAT is a series of tests that are performed as part of commissioning after the unit has been installed in the final location. (TR48)

  • Specific Model Virus

    Virus that is closely related to the known or suspected virus (same genus or family), having similar physical and chemical properties as those of the observed or suspected virus. (TR41)

  • Specification

    A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. (TR14)

    A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR38) (TR57)

    A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR69)

    A list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product, or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. (TR56) (TR74) 

  • Specificity

    The ability of an analytical procedure to accurately measure or detect a target analyte in the presence of other components in the sample matrix. (TR50)

    The ability to assess unequivocally the analyte in the presence of components that may be expected to be present. Typically these might include impurities, degradants, matrix, etc. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedure(s). (TR57)

    The ability to detect a range of microorganisms, which demonstrate that the method is fit for its intended use. (TR33)

  • Stability

    The capacity of a drug substance or a drug product to remain within specifications established to ensure its identity, strength, quality, and purity throughout the retest period or expiration dating period, as appropriate. (TR39)

    The chemical/biological fidelity of an analyte in a given solvent/matrix under specific conditions. (TR57)

  • Stability Budget

    A stability budget considers the results of long-term, accelerated, freeze-thaw, and temperature cycling studies to determine the amount of time out of storage that a drug substance may experience without any significant risk to its quality. Firms have used the idea of a stability budget to assign permissible time out of storage for packaging and labeling operations for refrigerated drug products for some time. This concept has been expanded in the present document to include storage and distribution as well. (TR53)

  • Stability Profile

    The physical, chemical, biological, and microbiological behavior of a drug substance or drug product as a function of time when stored under the defined environmental conditions of an approved protocol. (TR39)

  • Stability-Indicating Analytical Method

    A test procedure that is able to discern changes in an analyte due to degradation processes. It is capable of accurately measuring changes in the product that can occur under conditions of physical or chemical stress. (TR57)

  • Stakeholder(s)

    Any individual, group or organization that can affect, be affected by or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, health-care professional, regulatory authority, and industry (ICH Q9). (TR54) (TR54-2)

    Any individual, group, or organization that can affect, be affected by, or perceive itself to be af­fected by a risk. Decision makers might also be stakeholders. (TR54-5)

  • Standard Deviation

    <p>The statistical measure of the dispersion of the data. (TR57) </p>
  • Standard Pressure

    A pressure of 1 atmosphere (14.70 psi or 760 mm of mercury) to which measurements of quantities dependent on pressure are often referred. (TR45)

  • State of Control

    A condition in which the set of controls consistently provides assurance of continued process performance and product quality. (TR57)

  • Static Record Format (FDA)

    A fixed-data document such as a paper record or an electronic image.(TR80)

  • Static Record Format (MHRA)

    A "fixed" record such as paper or pdf. (TR80)

  • Static Record Format (WHO)

    A static record format, such as a paper or pdf record, is one that is fixed and allows little or no interaction between the user and the record content (TR80)

  • Statistically Determined Limits

    Limits calculated from historical data that takes into account the distribution of the data (i.e., normal, log-normal, exponential, etc), the variability of the data, and the sample size of the data set. These can be two-sided or one-sided. The mean (average) plus and/or minus 3 standard deviations or a confidence interval for the mean are not statistically correct methods for setting these limits. The correct method is to calculate a statistical tolerance interval as described in Hahn and Meeker, 1991. (TR38)

  • Stress Studies (Degradation Pathway Studies)

    Studies undertaken to elucidate the intrinsic stability of the drug substance and/or drug product; part of the development strategy and normally carried out under more severe conditions (e.g., high or low pH or oxidation levels, or shaking) than those used for accelerated testing. (TR57-2)

  • Superiority

    A comparison with the primary objective of showing that the result from one method is superior to the method being compared. This is usually demonstrated by showing that the true difference is likely to lie between zero and the upper equivalence margin. (TR57)

  • Surrogate Fluid

    A model process fluid used in a small-scale validation study. The fluid is intended to either match or resemble an actual process fluid as closely as is feasible. (TR41)

  • Systems (in computer or related systems) (FDA, attributed to ANSI)

    People, machines, and methods organized to accomplish a set of specific functions. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, operators, and associated documents(e.g., user manuals and standard operating procedures).(TR80)

  • Systems (in computer or related systems) (WHO)

    A computerized system collectively controls the performance of one or more automated processes and/or functions. It includes computer hardware, software, peripheral devices, networks and documentation, e.g., manuals and standard operating procedures, as well as the personnel interfacing with the hardware and software, e.g., users and information technology support personnel.(TR80)

  • Target Criteria

    Numerical limits, ranges, or other suitable measures of target performance levels of an analytical method that indicate suitable performance for intended use. For a method entering qualification, this is a target performance criterion that, when assessed, indicates that the method is qualified for its intended purpose. (TR57-2)

  • Target Product Profile (TPP)

    A format for a summary of a drug development program described in terms of labeling concepts to facilitate communication regarding a particular drug development program. (TR60) (TR60-2)

  • Test Article

    Any food additive, color additive, drug, biologi­cally derived product, etc., for human use or any other article subject to regulation. “Test Article,” in this report’s context, referring to the samples used for toxicity and stability studies. (TR56)

  • Total Impurities

    The sum of all impurities observed. (TR38)

  • Transfectoma

    Cells expressing exogenous proteins or reporter genes, produced by the transfection of continuously growing cells with gene expression constructs. (TR50)

  • Transition Analysis

    Mathematical evaluation of the chromatogram tracing as the mobile phase changes from one solution to another. An alternative to HETP and peak asymmetry for evaluating column packing and performance. (TR14)

  • True Copy (FDA)

    21 CFR 211.180(d) requires records to be retained "either as original records or true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records". Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original or raw data, which includes associated metadata and the static or dynamic nature of the original records.(TR80)

  • True Copy (MHRA)

    A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure as the original.(TR80)

  • True Copy (WHO)

    A true copy is a copy of an original recording of data that has been verified and certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record including, in the case of electronic data, all essential metadata and the original record format as appropriate.(TR80)

  • Unit Operation

    A discrete step or manipulation in a manufacturing process where process and operating parameters are defined to achieve a specific process objective. [Synonym: process step] (TR74)(TR14)

  • Work Breakdown Structure (WBS)

    A hierarchical and incremental decomposition of a project into phases, deliverables, and work packages; commonly a tree structure that shows a subdivision of effort required to achieve an objective. (TR65)

  • Working Cell Bank (WCB)/Working Virus Bank (WVB)

    A stock of cells or virus derived from the MCB/MVB and used to produce production cells, assay cells or virus production lots. (TR 47)

  • Working Seed Lot

    A seed lot generated from the master seed stock by a single passage. (TR51)

  • Worst Case

    A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. (TR60)

    A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. (TR62) (TR60-2)

  • Yield, Expected

    The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale or manufacturing data. (TR45)

  • Yield, Theoretical

    The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production. (TR45)