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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 #

 
 
  • Cake

    Solids deposited on the upstream side of filter media. (TR15) (TR45) (TR26)

  • Calibration

    The demonstration that an instrument or device produces results within specified limits when compared to those produced by a reference standard or a standard that is traceable to national or international standards, over an appropriate range of measurements (calibration range). (TR 1) (TR 30) (TR 48) (TR 61) 

    The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a refer­ence or traceable standard over an appropriate range of measurements. (TR 54-5)

  • Calibration Curve

    The relationship between measured response values and analytical concentrations of a standard or reference material. (TR57)

  • Calibration Tolerance

    In metrology, the maximum permissible range around a specified value that applies to a properly functioning measuring instrument. [Synonym calibration uncertainty, error](TR48)

  • Campaign

    A series of consecutive production batches manufactured without intervening cleaning and sterilization. (TR13) (TR22) (TR62)

    Processing of multiple lots or batches of the same product serially in the same equipment. (TR29) (TR49)

  • Campaigning

    Extending the period of time, or number of cycles a single-use system is operating in a closed process without breaking the sterile barrier processes. The end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR 66)

  • Capsule

    A self-contained filter device. (TR45)

  • Capsule Filter

    Compact, self-contained filter assembly. Generally, the whole assembly is disposable. (TR26) (TR41)

  • Captive Pallets

    A pallet intended for use within the confines of a single facility or system not intended to be exchanged. These are frequently metal or plastic pallets in Good Manufacturing Practices (GMP) manufacturing areas. (TR55)

  • Carrier

    A solid support upon which the test organism used in biological monitoring is inoculated. (TR51)

  • Cartridge

    A filter device requiring a housing for use. (TR45)

  • Cartridge Filter

    Filter elements encased in a housing. Generally, the filter elements are disposable while the housing units are multi-use. In a few cases, both filter and housings are disposable. (TR26) (TR41)

  • Cassette

    A tangential flow filtration module containing flat sheet, semipermeable membranes, feed channel and filtrate flow channels. (TR15)

  • CE Marking

    The CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. (TR58)

  • Cell Line

    Type of cell population with defined characteristics that originates by serial subculture of a primary cell population that can be banked. (TR83)

  • Cell Substrate

    The host cells that are used to propagate or detect viruses. (TR 47)

    Cells used for the manufacture of a biological medicinal product. (TR 71) (TR 83)

  • Cells at Limit of invitro Cell Age Used for Production

    Cells used for production which are at the limit of their invitro cell age. Note Also known as, “End-of-Production-Cells”. (TR56)

  • Certificate of Analysis (CoA)

    The certification by a supplier of the performance of the material tested against a set of specifications, such asidentity, purity, moisture content, pH, color, bioburden, endotoxin, etc. (TR56)

  • CFU: Genome Copy Ratio

    The relationship between the number of colony forming units counted on solid media and the number of genome copies measured using a method suitable for quantitative assessment of genomic DNA. (TR50)

  • CGMP Record (FDA)

    When generated to satisfy a CGMP requirement, all data become a CGMP record. You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and 211.160(a). FDA expects processes to be designed so that quality data is created and maintained and cannot be modified. (TR80)

  • Challenge Concentration

    The concentration in Colony Forming Units/mL of the test microorganism in the challenge fluid. (TR75)

  • Challenge Fluid

    The carrier fluid in which the test microorganism is suspended and delivered to the test filter. (TR75)

  • Challenge Level

    The concentration of the test microorganism applied to the test filter (per centimeter squared) or the total number of cells applied to the test filter at the completion of the challenge. (TR75)

  • Challenge Volume

    The volume of challenge fluid applied to the test filter. (TR75)

  • Chamber

    The primary component of a sterilizer that contains the items to be sterilized. The chamber is a pressure rated vessel. (TR1) (TR 48)

    The primary structural element of a sterilizer that contains the products to be sterilized. The chamber is a pressure (positive and/or negative) rated vessel. (TR30)

  • Chamber Cold Spot

    The location(s) within the load zone that achieves the lowest process lethality (F0) and/or the lowest distribution temperatures during the sterilization process. (TR01)

  • Chamber Heat-Up Time

    The elapsed time measured from the introduction of steam in the heat-up phase (“steam on”) to the point when the temperature of the heating medium within the chamber reaches the exposure temperature set point. (TR01)

  • Chamber Leak Test

    A test conducted to evaluate possible air infiltration to the chamber under vacuum. [Synonym: Vacuum Leak Test] (TR1) (TR48)

  • Change Control

    A formal program that describes evaluation and actions to be taken if a change is proposed or completed to facilities, materials, equipment, and/or processes used in the fabrication, packaging, and testing of drugs, or a proposed or completed change that may affect the operation of the quality or support systems. (TR22) (TR39) (TR52) (TR58) (TR64) (TR 70)

  • 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)

  • Characterization Method

    Scientifically sound method of a generally complex nature that is used for nonroutine assessment of specific biochemical, chemical, physicochemical, immunochemical, microbiological, and biological characteristics or inherent properties of a compound. (TR 57-2)

  • Characterization Study

    A series of tests designed to increase process knowledge by examining proposed operational ranges and their individual and/or combined impact on the chromatography process. (TR14)

    A late-stage study that evaluates the process to increase process knowledge and examines proposed operational ranges and their individual and/or combined impact on target protein quality. (TR42)

  • Chemical Compatibility

    The relative stability of filter materials and/or filter assembly components when exposed to process fluids and process parameters. (TR45)

  • Chemical Indicator

    Test system that reveals change in one or more predefined process variables based on a chemical or physical change resulting from exposure to a process. (TR01) (TR30)

  • Chemical Integrator

    A device that is designed to react in a quantitative manner to multiple sterilization variables, (typically, time and temperature and, in some instances, moisture). (TR01) (TR30)

  • Chemistry Manufacturing and Controls (CMC)

    The body of information that defines the technical development, manufacturing facility and support utilities; the process equipment and materials used in manufacturing; the manufacturing process itself; the personnel involved in manufacturing and qual­ity; the chemistry of the product; QC in process and release testing, specifications, and stability of the product; all of the controls, documentation, and training necessary to ensure that all of these listed ac­tivities are properly and effectively carried out. (TR56)

  • Chromatogram

    Data recorded during performance of a chromatography unit operation typically includes UV absorption (280 nm), pH, and conductivity, as well as other data (e.g., flow rates or pressure). (TR14)

  • Chromatography

    The passage of a solute (mobile phase) through resin (stationary phase) to achieve purification of substances based on the chemical, physical, and biological properties of the molecules involved. (TR14)

  • Chromatography Resin

    Material used to interact with the process stream in order to purify the target protein. Chromatography resin usually consists of porous particles within a defined particle size range that are insoluble in the process stream (e.g., ceramic beads, agarose). (TR14)

  • Clarification

    The removal of solid particulates from a liquid through filtration, sedimentation, centrifugation or other means. (TR45)

  • Class I Recall

    A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. (TR55)

  • Class II Recall

    A situation in which use of or exposure to a violative product or may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.(TR55)

  • Class III Recall

    A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.(TR55)

  • Clean

    Having product residues, process residues, and environmental contaminants removed to an acceptable level. (TR29) (TR49)

    The implementation of procedures to render an area, piece of equipment, system, or object free of adulterants and contaminants. (TR 70)

  • Clean Hold Time

    The time from the end of the cleaning process until the equipment is used again (which may be product manufacture, autoclaving, or a steam in place (SIP) cycle). (TR29)

  • Clean in Place (CIP)

    The process of rinsing or washing of process components, as installed without removal, in order to remove or eliminate any contaminants. (TR45)

  • Clean Water Flux

    A baseline filter flow measurement performed with clean water or a buffer, at a specified transmembrane pressure and temperature. (TR15)

  • Clean(liness)

    The measurement for the level of particulates, microbes, or other extraneous substances on an item or surface. (TR 70)

  • Cleaning

    The process of removing foulants from the membrane structure during normal processing, either through physical or chemical means. (TR13) (TR15)

    The removal of adherent visible soil from the surfaces, crevices, serrations, joints, and lumens of instruments, and from devices and equipment, by a manual or mechanical process that prepares the items for safe handling and/or further decontamination. The cleaning process should leave surfaces that are visibly free from foreign material. (TR51)

  • Cleaning Agent

    The solution or solvent used in the washing step of a cleaning process. Examples of cleaning agents are water, organic solvent, commodity chemical diluted in water, and formulated detergent diluted in water. (TR29) (TR70)

  • Cleaning Procedure

    The documentation that assures any product and process-related material introduced into equipment as part of the manufacturing process stream is removed and the equipment is adequately stored. (TR29)

  • Cleaning Process

    A process that is used to remove any product, process-related material and environmental contaminant introduced into equipment as part of the manufacturing stream. (TR29)(TR49)

  • Cleaning Validation

    Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)

  • Cleaning Verification

    A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)

  • Cleanroom

    A room designed, maintained, and controlled to prevent particle and microbiological contamination of a drug product or medical device. A cleanroom is assigned and reproducibly meets an appropriate air cleanliness classification. (TR13)

  • Clinical Protocol

    A document, together with any amendments to it, that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. (TR63)

  • Clinical Trial Material (CTM)

    A drug or combination of drugs and/or excipients that are produced with the intent that it be used in a clinical trial, or that is released or otherwise authorized for use in such. This could, subject to appropriate regulatory approval, be an experimental medicine, a product with marketing authorization used in a clinical trial within or beyond the approved indication and/or any placebo articles produced for use in a clinical trial. (TR63)

  • Clinician

    A physician, psychiatrist, etc., who specializes in clinical work as opposed to one engaged in laboratory or experimental studies. (TR58)

  • Cloning

    The process of creating identical copies of DNA fragments or a homogeneous preparation of cells, viruses or other organisms. (TR47)

  • Closed System

    An isolated system that has no interaction with its external environment, preventing contamination and release of the material contained.(TR28) (TR 66)

  • Coefficient of Determination (r²)

    A measure of the proportion of the variation of one variable determined by the variation of the other. (TR57)

  • 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)

  • Cold Chain Tolerance Groups

    This concept expands the “normal” definition of cold chain to include all products that need to be stored below 250C and also introduces the ancillary terms “ambient temperatures” and “controlled ambient”. (TR46)

  • Cold Spot

    The location within an SIP system that achieves the lowest process lethality (F0) during a SIP process. Note: When lethality values are not available or not applicable (e.g., a sanitization process operating at less than 100 °C) the cold spot is the location with the lowest temperature profile during the SIP cycle. (TR61)

  • Colloid

    A mixture with properties between those of a solution and a fine suspension. (TR45)

  • Colonization (Microbial)

    Growth (division) of adherent microorganisms on a surface (TR 69)

  • Colony Forming Unit (CFU)

    One or more microorganisms that produce a visible, discrete growth entity on a semi-solid, agar-based microbiological medium. (TR22) (TR62)

    Visible outcome of growth of microorganisms arising from a single or multiple cells. (TR28)

    A single microorganism or an aggregate of many that forms a single discrete colony on solid agar media after suitable incubation. Colony forming units are used for bacterial titer (total bacteria load in a sample) determination on solid media. (TR50) (TR75)

  • Color Changing Unit (CCU)

    The quantity of mycoplasma contained in the highest dilution of a test article that produces a color change in a pH-sensitive liquid medium (typically containing phenol red) within a specified time of incubation, used for end-point determination of growth. (TR50)

  • Column Load

    The solute that is passed through the column for separation. (TR14)

  • Column Packing

    Preparation of a column that includes the addition of resin slurry into a column to create a bed suitable for its intended use. Characteristics of a packed column bed include bed height and diameter, backpressure, and number of theoretical plates. (TR14)

  • Commissioning

    A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases:
    1. Inspection, testing, and regulation
    2. Adjustment and setting of work
    3. Functional testing (TR 3)

    A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48)

    A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)

  • Common Carrier

    Transportation available to the public that does not provide special treatment to any one party and is regulated as to the rates charged, the liability assumed, and the service provided. A common carrier must obtain a certificate of public convenience and necessity from the Federal Trade Commission for interstate traffic. (TR46)

  • Comparability

    The quality or state of being suitable for comparison. FDA may determine that two products are comparable if the results of the comparability testing demonstrate that a manufacturing change does not affect identity, strength, quality, purity, or potency as they may relate to the safety or effectiveness of the product. (TR38)

  • Comparability Protocol

    A protocol submitted by an applicant under CFR 601.12(e) and 314.70 (g) that describes the specific tests and validation studies and acceptable limits to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, and potency of the product as they may relate to the safety or effectiveness of the product. Any such protocols, or change to a protocol, shall be submitted as a supplement requiring approval from FDA prior to distribution of the product. The supplement, if approved, may justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect. (TR38)

  • Comparability Study

    An assessment of the similarities between the critical parameters and output results of two or more separate processes or methods. (TR50)

  • 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)

  • Compatibility

    Proof that no adverse interaction between the filter and the process fluid has occurred. (TR26)

    A term used in relation to the non-reactivity of filter materials with the substance to be filtered. (TR45)

  • Compatibility (Filter)

    The ability of a filter to be used with a particular process fluid without a change in the inherent properties of the filter. (TR41)

  • Compendial Procedure

    A method that is considered validated as published in one of the recognized compendia. (TR57)

  • Complaint Files

    (a) As defined by 21 CFR Part 211.198- Complaint Files. (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility.
    1.The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant .
    2.Where an investigation under 211.192 is conducted, the written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with 211.180. (TR55)

  • Complete Data (FDA)

    FDA requires complete data in laboratory records, which includes raw data, graphs, charts, and spectra from laboratory instruments and associated metadata. (§§ 211.194(a) and 212.60(g)(3) (2). A complete record of all data secured in the course of each test, including date and time the test was conducted and all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested. (TR80)

  • Component, Primary

    Element of the assembled prefilled syringe (needle, plunger stopper and tip closure, or adhesive) directly in contact with the drug. (TR 73)

  • Component, Secondary

    Element of the assembled prefilled syringe (plunger rod, backstop, or safety system) that interacts with the primary components and provides functionality to the delivery system. (TR 73)

  • Composite Membrane

    A membrane consisting of multiple layers. (TR15)

  • Compounding

    A process in which a bulk drug substance is combined with one or more excipients and/or another bulk drug substance to produce a drug product. (TR22)

    A process wherein bulk drug substance is combined with one or more excipients and/or another bulk drug substance to produce a drug product. (TR62)

    The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:
    • Preparation of drug dosage forms for both human and animal patients
    • Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns
    • Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients
    • Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis
    • Preparation of drugs and devices for prescriber’s office use where permitted by federal and state law. (TR63)

  • 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)

  • Concentrate

    The concentrated feed solution after the removal of filtered liquid through the membrane and into the filtrate. [Synonym: retentate, retentate solution] (TR15)

  • Concentration Factor

    The ratio of the initial feed volume to the retentate volume. (TR15)

  • Concentration Polarization

    A phenomenon in which the concentration of retained solutes increases in the region adjacent to the membrane surface due to limitations in particle transport back into the bulk solution. (TR15)

  • Concurrent Validation

    Validation that occurs during manufacturing of drug substance for batches that can be released and used in a final drug product for commercial distribution based on thorough monitoring and heightened testing of the drug substance batches. (TR42)

  • 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

    Batches prepared to demonstrate when the process operates according to defined ranges of operat­ing parameters and under controlled conditions, meet predetermined quality attributes (sometimes referred to as “validation” batches and demonstra­tion batches). (TR56)

  • 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)

  • Consumables

    This refers to items (e.g., SUS, storage bags, tubing, filters, diaphragms, flasks, etc.) that form or are a part of process equipment and are used on a per batch basis. (TR66)

  • Contact Time

    The minimum amount of time that a sanitizer, disinfectant, or sporicide must be left in complete (wet) contact with the surface to be treated in order to be effective. (TR70)

  • Container Closure Integrity (CCI)

    The ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards.(TR76)

  • Container Cold Spot

    The location within a sealed liquid container that achieves the lowest process lethality (F0) during a sterilization process. (TR01)

  • Contaminant

    Any adventitiously or externally introduced material(s) (e.g., chemical, biochemical, or microbial species) not intended to be part of the process. (TR14) (TR15) (TR70)

    An undesired impurity of a chemical or microbiological nature that is introduced into a raw material, intermediate, or API (drug substance) during manufacture. (TR14) (TR15)

    Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product. (TR69) (TR74)

    Any adventitiously introduced material (e.g., chemi­cal, biochemical) or microorganisms including viruses not intended to be included in the manufacturing process of the drug substance or drug product. (TR83)

  • Contamination Rate

    The percentage of units filled in a process simulation that are positive for microbial growth after incubation. (TR22)

  • Contextual Inquiry

    Ethnographic research method used to observe and analyze behaviors in actual end-use contexts (actual environments and use scenarios). (TR73)

  • Continual Improvement

    Recurring activity to increase the ability to fulfill requirements. (TR54)

  • Continued Process Verification (CPV)

    Assuring that during routine production the process remains in a state of control. (TR60)

    US FDA: Assuring that during routine production the process remains in a state of control. ICH: An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. (TR60-2)

  • Continuous Convection Tunnel

    A convection oven with a conveyor belt that transports articles through several temperature zones that are supplied with heated forced HEPA filtered air. The pre-heat/loading zone warms articles prior to the heat zone, the heat zone heats articles to sterilization or depyrogenation temperature and the cool zone cools articles prior to conveyance out of the unit. [Synonym: Tunnel Sterilizer] (TR3)

  • Continuous Monitoring

    A mechanism by which temperature is regulated and recorded without interruption. It is recommended that if the system is not alarmed, it must be checked at predetermined time intervals. The time intervals should be determined by the facility but should be adequate enough to provide meaningful data of the temperature change over time. (TR46)

    A process of data collection in which conditions are monitored continuously throughout the operation. In most U.S. applications, this definition implies “during production.” (TR13)

  • Continuous Process Verification

    An alternative approach to process Validation in which manufacturing process performance is continuously monitored and evaluated. (TR60)

  • Continuum of Criticality (As Used for Attributes)

    Following comprehensive assessments of scientific evidence and risk, quality attributes are ranked according to the degree of criticality. The continuum, as opposed to binary classifications of Critical and Non-Critical, is thought to “more accurately reflect complexity of structure-function relationships and the reality that there is some uncertainty around attribute classification”. (TR60)

  • Continuum of Criticality (As Used for Parameters)

    A non-discrete scale where parameters or attributes are evaluated relative to their impact on drug substance and drug product quality. (TR60)

  • Control Standard Endotoxin (CSE)

    Endotoxin preparations other than the international or national reference standards that are traceable in their calibration to the international endotoxin reference standard. A CSE is a secondary or tertiary standard, commonly purified from Escherichia coli, and is usually manufactured and certified by an LAL reagent manufacturer for use with a specific lot of reagent under defined assay conditions.(TR82)

  • Control Strategy

    A planned set of controls, derived from current product and process understanding, which ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. (TR 54) (TR 60) (TR 54-5) (TR56)

  • Control Valve

    A device that modulates the flow of fluid (e.g., gas, steam, water) in a conduit in response to a signal from a process measurement control system. (TR48)

  • Controlled Area

    An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination (an air supply approximating to Grade D may be appropriate), and the consequences of accidental release of living organisms. The level of control exercised should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure positive to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants. (TR13)

  • Controlled Environmental Space (CES)

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

  • Controlled Room Temperature (CRT)

    Defined by USP <1079> as the usual and customary working environment of 20 °C to 25 °C (68 - 77 F) that allows for deviations between 15 °C and 30 °C (59 - 86 F) based on stability data. (TR58)

  • Convection

    The transfer of heat by the circulation or movement of the heated liquid or gas. (TR3)

  • Cool-Down Phase

    The phase of a sterilization cycle that occurs after completion of the exposure phase. Parameters of a cool-down phase are typically defined in order to meet applicable user requirements for load cooling and drying. (TR01)

    The phase of a sterilization cycle that occurs after completion of the exposure phase. [Synonym: post-conditioning phase, slow exhaust phase, drying phase, equalization phase] (TR48)

    The phase of an SIP cycle that occurs after completion of the exposure phase. Parameters (e.g., time, temperature, pressure) of a cool-down phase are typically defined in order to meet applicable user requirements for system cooling and drying. (TR61)

  • Corked or Cork Taint

    A musty-moldy off-flavor or taste imparted to the wine primarily due to the presence of 2, Combination Products 6-trichloroanisole (2, Combination Products 6-TCA) produced by the fungalo-methylation of 2, Combination Products 6-tricholorophenol (TCP) associated with corks, wooden barrels, and construction materials in wineries. (TR55)

  • Corrective Action

    Actions taken to eliminate the cause of an existing (corrective) or potential (preventative) non-conformity to prevent its recurrence. (TR52)

    Action to eliminate the cause of a detected non-conformity or other undesirable situation. (TR54)

    A response taken to remediate the effect of an excursion or product failure. (TR13)

  • Corrective Action and Preventative Action (CAPA)

    Action to eliminate the cause of a detected nonconformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. (TR 52) (TR 54-2) (TR 54-3) (TR 54-5)

  • Correlation Coefficient ( r )

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

  • Corrugate (also known as cardboard or fiberboard)

    A thin, stiff material made of pressed paper pulp or pasted sheets of paper and used, for example, for making cartons or fiberpak drums. (TR55)

  • 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)

  • Cosmetics

    Personal care product formulations used to enhance an individual’s visual appearance or eliminate odor. This broad definition also applies to any material intended for use as a component of a cosmetic product. Note: The FDA specifically excludes soap from this category. (TR67)

  • Coupon

    A small, generally flat portion of a defined material of construction (such as stainless steel or PTFE) and of a defined surface finish, typically used for laboratory cleaning evaluations and/or for laboratory sampling recovery studies. (TR29) (TR49)

  • Co-Validation

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

  • Coverage

    The appropriate distribution of a chemical agent needed on the equipment surface to be effective. (TR70)

  • 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 Area/Critical Zone

    An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas. (TR13) (TR22) (TR44) (TR62)

  • Critical Aspect Design Elements (CADE)

    Critical aspect design elements are components, instruments, and process controls that comprise the critical aspect (e.g., temperature feedback loop). Critical aspect design elements are tested in commissioning and qualification. (TR54-5)

  • Critical Aspects (CAs) of Manufacturing Systems

    Critical aspects are constituent parts of a system or piece of equipment that provide the ability to control one or more critical process parameter of the associated process (e.g., temperature control­ler of a bioreactor). (TR54-5)

  • 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 Processing Zone

    The location within the aseptic processing area in which product and product contact surfaces are exposed to the environment. The Critical Processing Zone is dependent upon machine design and includes, but is not necessarily limited to, the parison extrusion and cutting area, mold transfer area, air shower, and point-of-fill. (TR77)
  • 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)

  • Critical Surface

    A surface within a critical area that may come in direct contact with sterilized products, containers, or closures. (TR13)

  • 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)

  • Cross-Flow Filtration

    See Tangential Flow Filtration. (TR15)

  • Cross-Flow Rate

    Volumetric rate of fluid flow parallel to the membrane surface. (TR15)

  • Cryopreservation

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

  • Culture Medium

    The nutritional medium which supports the growth of the given microorganism. (TR75)

  • 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)

  • Customer

    In distribution, the trading partner or reseller, and In direct-to-consumer, the end customer or user (TR46)

  • 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)

  • Cycling

    A study designed to stress test the product and provide specific information on its ability to withstand transient high and low temperature excursions during distribution and storage. Typically the study conditions are outside of ICH accelerated conditions.(TR53)

  • Cytopathic Effect (CPe)

    Morphological changes induced by viruses in infected cells in invitro culture. They are usually localized around a site of initial infection and vary in appearance based on the virus and the cultured cell. (TR47)

  • Cytopathic Virus

    Viruses where infection of cells results in microscopically visible degeneration of the cells or other morphological changes. (TR47)