PDA Glossary

Is the measure of the ability of the package to prevent product loss or maintain product sterility and the ability to maintain the internal environment (2). (TR86)

Procurement of a product such as liquid or powder format culture media or buffer and that has been supplied in single-use technology. (TR66)

Insulated container that uses refrigerant to keep a product within a specified temperature and time range; see passive system. (TR58)

Pallets are flat transportation structures that are used in the efficient shipping, warehousing and in-plant distribution of goods. A loaded pallet may be moved using a fork lift or pallet jack. They are usually 48 x 40 inches in dimension. They are most commonly constructed of wood but may be plastic, metal or even paper. (TR55)

(TR14)

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)

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)

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)

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)

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)

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)

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)

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)

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

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)

A sterility release system based upon effective control, monitoring, documentation, and batch records review of a validated sterilization process cycle in lieu of release procedures based upon end-product sterility testing. (TR01) (TR3) (TR13)

A sterility release program based on effective control, monitoring and documentation of a validated sterile-product manufacturing process where sterility release is based on demonstrated achievement of critical operational parameters and performance attributes in lieu of end-product sterility testing. (TR30)

The “tube” of polymer extruded by the BFS machine from which the containers are formed. (TR77)

1 part in 1 x 1⁰⁹ total parts. Can be measured in mass/mass (e.g., 1 nanogram/gram) or in volume/volume (e.g, 1 nanoliter/liter). (TR55)

1 part in 1 x 10¹² total parts. Can be measured in mass/mass (e.g., 1 picogram/gram) or in volume/volume (e.g, 1 picoliter/liter). (TR55)

A qualification method that uses less than the full exposure time to demonstrate sterilization or sanitization cycle efficacy. [Synonym: fractional cycle.] (TR61)

Any discrete unit of material structure; a discernible mass having an observable length, width, thickness, size and shape. (TR45) (TR26)

Foreign material which is unintended and either removable from the surface of a primary packaging component or freely moving within a filled and sealed pharmaceutical dosage form. The term particle is used interchangeably with “particulate” and “particulate matter” without any intended difference in meaning. (TR85)

Particles that are not part of the formulation but are foreign and unexpected. Examples of extrinsic particles include fibers (e.g., cellulous), clothing fragments, hair, foreign rubber (including degraded/reverted rubber of the same formulation), metal, plastic, and paint. Materials such as foreign rubber, metal, and plastic are defined as extrinsic in cases where the specific material identified is not a material of construction and therefore not considered part of the rubber formulation.(TR76)

Particles that are expected from the drug formulation, and therefore not included as a category in this Lexicon.(TR76)

Particles that arise from sources related to the materials of construction of the component. Examples of intrinsic particle materials include elastomeric particles of the same formulation or ingredients from elastomer for elastomeric components. (TR76)

Relating to, or occurring in the form of particles. (TR45) (TR26)

The total quantity of particles in solution as tested per qualified method. (TR76)

Particulate matter consists of mobile, randomly-sourced, extraneous substances, other than gas bubbles, that cannot be quantitated by chemical analysis due to the small amount of material that it represents and its heterogeneous composition. (TR79)

Propogation of a seed stock by serial sub-culturing. (TR51)

The length of time that the temperature remains within the acceptable range when power is lost. (TR64)

Systems without active temperature control. Refrigerants may be, for example, gel packs, dry ice, water, and/or ice. Examples include insulated containers, packouts and cool boxes/containers. (TR58)

Systems without active temperature control (e.g., insulated containers with or without refrigerants). (TR39)

Transportation systems without active temperature control (e.g., insulated containers with or without refrigerants). (TR64)

Any microorganism which by direct interaction with (i.e., infection of) another organism causes disease in the organism (by convention, a multi-cellular organism). (TR51)

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)

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)

A statement of origin for a drug, active ingredi­ent, or other critical starting material that identi­fies the original source of the material and each sale, purchase, or trade prior to receipt by the user, including the dates, names, and addresses of all parties involved in such transactions. Note: Also called a “batch tree.” (TR56)

A pedigree is a record, containing information regarding each transaction, resulting in a change of ownership of a prescription drug, from sale by a manufacturer, through acquisition and sale by a wholesaler, until final sale to a pharmacy or person furnishing, administering or dispensing the prescription drug. (TR46)

A review of data by a colleague who has a similar level of responsibilities as the person performing the activity or capturing the data. (TR84)

Peltier devices are small, solid-state ceramic and doped-semiconductor sandwiches designed to function in small cooling and heating applications. The devices can be “stacked” for greater cooling/heating but do draw considerable power. The advantage of these devices is that there are no moving parts, no maintenance, no refrigerant gasses, no noise, and no vibration. Disadvantages may include: high cost, fragility, and scalability, in addition to the aforementioned high power draw. (TR46)

A probe placed in contact with the load item or inside a container of liquid to measure the temperature of the load item or liquid. (TR01)

A thermocouple placed in contact with the load item to measure the temperature of the load item. (TR3)

A thermocouple that is placed in or against the material/product to measure the material/product temperature. (TR64)

A small, ceramic carrier surface used to hold cultures of microorganisms. Used in antimicrobial effectiveness testing procedures. (TR70)

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)

An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. (TR60-3)

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)

Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications (17). (TR60-3)

Measured length of the outer edges of a particle.

Re-execution of qualification studies performed on a periodic basis to verify that systems and pro­cesses remain able to produce a result that con­sistently meets predetermined acceptance criteria through execution of a lab or field study. (TR54-5)

A documented review of pertinent data as appro­priate (for example, manufacturing performance trend data, change history, deviation history) to confirm that a process/method/system continues to consistently produce a result meeting prede­termined acceptance criteria. (TR54-5)

The degree to which a fluid will pass through a permeable substance under specified pressure and temperature conditions. (TR41) (TR26)

The fluid which passes through a membrane. (see also filtrate) (TR41)

Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. Any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant and any nitrogen stabilizer. (TR70)

General classification of drug products based largely on their route of administration and presentation (e.g., compressed tablets, powder-filled capsules, topical creams and nasal sprays). (TR67)

Includes drug substances, excipients, processing aids and ingredient water. (TR67)

Management system to direct and control a pharmaceutical company with regard to quality. (TR54) (TR54-5)

A licensed pharmacist who is assigned the responsibility and authority for establishing and implementing policies and procedures for all operations of the pharmacy and to ensure the pharmacy operations and practices comply with all requirements of national and local pharmacy and drug laws, rules, and regulations. (TR63)

How the drug works in the body, the biochemical and physiological effects of drug and its mecha­nisms of their actions. (TR56)

How the body processes the drug; the study of the movement of drugs in the body, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion. (TR56)

A manual typically created and provided by the study sponsor that contains specific information and documentation to allow the clinical sites to properly receive, store, prepare, label, dispense and return clinical trial material and document the related activities at the clinical site. Note: For this report, the pharmacy manual will also contain specific instructions for the extemporaneous preparation, labeling and dispensing of clinical trial materials. (TR63)

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)

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) and are designed to assess efficacy, as well as to continue safety assessments in a larger 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)

Final clinical stage Phase 3 trials are designed to demonstrate the potential advantages of the new therapy; safety and efficacy of the new therapy are studied over a longer period of time, and more patients (1,000-3,000) are enrolled in 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 long term use. (TR56)

A physical material that stores and releases thermal energy when freezing or melting. A PCM releases energy when freezing [latent heat energy] and absorbs energy when melting. (TR46)

A component of performance qualification that demonstrates that predetermined physical requirements, including temperature distribution and heat penetration, are achieved consistently throughout the load. (TR01)(TR03)

The manufacturing of a drug substance by a procedure fully representative of and simulating that to be applied to a production-scale batch. (TR38)

A schematic diagram that shows the relational arrangement of piping, components, instruments, and equipment connections of the system. It also illustrates the control and functional relationship. (TR48)

Suspended in the bulk phase of a fluid as opposed to being attached to surfaces. (TR69)

A complete list of the raw material (chemicals, media, powders, resin, etc.) and consumables/components (filters, bags, tubing, containers, etc.) that are required to manufacture the product. (TR65)

Utilities include pharmaceutical-grade water systems, compressed gases, pharmaceutical-grade air systems, heating, ventilation and air conditioning systems, and space pressurization. (TR67)

A measure of virus infectively based on formation of a region, or “plaque” of lysed cells within a monolayer culture caused by viruses that kill and disrupt their host cell. The number of plaques is directly correlated to the number of infectious virus particles. (TR47)

The process of extracting virus from a lawn of plaque for growth in cell culture. By performing several rounds of plaque purification a virus clone can be isolated. (TR47)

An extra-chromosomal DNA molecule in bacteria which is capable of replicating independently of the host chromosomal DNA. Plasmids are often used as positive controls for NAT assays. (TR50)

A membrane-module geometry, utilizing flat sheet membranes, in which membranes are stacked between supporting plates. (TR15) A device used to support filter sheets and provide inlet- and outlet-flow channels. It is composed of a series of filters sheets separated by alternating plates (outlets) and frames (inlets) that are compressed between two end-plates (heads) by either hydraulic or mechanical means. (TR45)

Development of a production strategy for a new drug starting from manufacturing processes similar to those used to manufacture other drugs of the same type (the production for which there already exists considerable experience). (TR60)

Existing method based on the same basic principles and steps as a new method that is required and defined in the design/strategy phase; applies to multiple sample types and requires minimal changes or refinements based on specific product requirements. (TR57-2)

The combined components of the plunger rod and plunger stopper. (TR73)

Portion of the plunger assembly which provides a thumb pad for depressing the plunger and is attached to the plunger stopper inside the syringe barrel. (TR73)

Elastomeric component, which acts as a seal to prevent product leakage and also as the portion of the syringe which forces the expulsion of the contents of the syringe when depressed. (TR73)

Circumferential contact points between the ribs of the plunger stopper and the inner diameter of the syringe barrel. (TR73)

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)

The channel(s)/path(s) in a membrane through which a fluid or a gas may pass. (TR41) (TR26)

The size of the channel passages through the filter media. (TR41)

The range of pore sizes in a filter used to determine the filter’s average pore size. (TR15)

An analytical technique used to determine various quantifiable aspects of a material’s porous nature, such as pore diameter, total pore volume, surface area, and bulk and absolute densities. (TR41)

The ratio of void volume to bulk volume of the filter media. (TR26)

The percentage of a membrane’s volume that is occupied by pores. (TR15)

A porous/hard goods load consists of items in which the bioburden is inactivated through direct contact with saturated steam. Porous/ hard goods load items include: filters, stoppers, tubing (hoses), mops, garments, stoppers, cleaning equipment, or machine change parts. (TR01)

A test article used to assess the performance of an assay in the known presence of a targeted microorganism or nucleic acid. A positive control is used to monitor the performance of assay routinely and during validation. For culture-based assays, a live mycoplasma preparation must be used to show that the assay was run properly. NAT positive controls use a nucleic acid with the target sequence of interest. (TR50)

A control filter membrane with a larger pore size rating than the test filter and used to demonstrate the penetrative ability of the test microorganism. Penetration of this filter by at least one CFU is required to validate a test. (TR75)

Unit filled in an aseptic processing simulation that exhibits detectable microbial growth after incubation. (TR22) (TR62)

Inspection of glass containers after product filling. (TR43)

The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product that is linked to the relevant biological properties. (TR57)

An expression of the activity of a secondary calibration standard to relate units of weight (ng/ vial or ng/mL) to units of activity (EU/ng) in a preparation.(TR82)

A potential drug shortage is described as the occurrence of internal or external situations (single or in a combination of both), which could result in an interruption of supplies of a medicinal product, if not properly addressed and controlled. (TR68)

Powders are defined as a solid or a mixture of sol­ids in a finely divided state intended for internal or external use. Powders used as pharmaceutical dosage forms may contain one or more APIs and can be mixed with water for oral administration or injection. (TR79)

The interpretation, evaluation and implementation of medical orders which may include the administering, preparing, compounding, preserving, and/or the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions, clinical protocol or other legal authority. Note: Many localities have broader definitions describing very specific activities and responsibilities that further defines the practice of pharmacy. (TR63)

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)

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

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

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

Syringes and associated components considered as starting material for the filling and assembling process of a prefilled syringe. (TR73

Syringe assembly after being filled with pharmaceutical product and being closed. (TR73)

A syringe that has been prefilled to contain a specific dose of medication. (TR73)

Any filter placed upstream of the final filter. (TR26)

A tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product or system (ICH Q9). (TR54) (TR54-2) (TR54-3) (TR54-4)

A tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product or system. (TR54-5)

An approved document that gives the detailed instructions for preparation of the Clinical Trial Materials (CTM). (TR63)

The location where extemporaneous preparations of Clinical Trial Materials (CTM) are made. (TR63)

Force applied per unit area, usually expressed as psi, mbar, kPa or kg/cm². (TR45) (TR26)

A leak test in which a container or system is pressurized with air to a preset level. After the pressure has stabilized, the decay in pressure over a preset test time is measured and evaluated to determine if a leak (defect) is present. (TR66)

A test for leaks and gross defects in which the system is held at a defined pressure for a defined time. Failure is indicated by the observation of a steady stream of air bubbles downstream of the filter. (TR41)

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

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

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

Number of viable organisms present on or in product prior to exposure to the sterilization process. (TR30)

A sterilization process in which air is removed from the chamber using a vacuum pump or other mechanical system before the exposure phase begins. This method is particularly suited to load items that can trap air such as tubing, filters and filling machine assemblies. (TR01)

A process in which air is removed by applying a vacuum (i.e., negative pressure) or pulses of vacuum to precondition the system prior to the exposure phase. (TR61)

Action to eliminate the cause of a potential non-conformity or other undesirable potential situation. NOTE: Preventative action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. (TR54)

Substance shown by extensive analytical testing to be authentic, representative material; can be
1) obtained from an officially recognized source,
2) prepared by independent synthesis,
3) obtained from existing production material, or
4) prepared by further purification of existing product material; is representative of the production process, so distinct reference materials for product-related substances, product-related impurities, and process-related impurities may need to be established. (TR57-2)

All process surfaces that have a direct influence on the quality of the drug substance being manufactured, including surfaces processing equipment, storage containers, and of processing aids during manufacturing operations. (TR54-4)

Packaging that protects the inoculated carrier from damage and contamination without preventing penetration of the sterilizing agent(s). (TR51)

A component that is (or may be) in direct contact with the dosage form. Some examples of primary components are glass vials, syringe barrels, bottles, rubber closures, and container or closure liners. (TR39)

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)

A method that is the converse of a deterministic leak test method, being stochastic in nature. Probabilistic tests rely on a series of sequential and/or simultaneous events, each associated with random outcomes described by probability distributions. (TR86)

The number that expresses the probability of occurrence of a non-sterile unit after exposure to a sterilization process. Within the pharmaceutical industry, a design end point better than or equal to the probability of one non-sterile unit in a million units is expected, i.e., PNSU ≤ 10–6. [Synonym: Steriliy Assurance Level (SAL)] (TR01)

The likelihood of detecting a defective unit dur­ing an inspection process expressed as a prob­ability, quantitatively as a number (0–1) or as a percentage (0–100%). (TR79)

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

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)

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

A study that evaluates the process to increase process knowledge and examines proposed ranges and their individual and/or combined impact on target protein quality. Process characterization studies include deliberate variation of parameters to determine their effect on product quality attributes, often conducted as small-scale studies. (Also known as process evaluation studies, process justification studies, engineering studies, development studies, robustness studies, or process design studies. (TR60)

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)

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)

A report that includes results from a process characterization study with information on the performance of one or several unit operation(s). The report describes process characteristics, the parameters (e.g., critical or noncritical) and their studied ranges (limits) and may outline acceptance criteria for process performance qualification protocols.(TR60)

Conditions and corresponding measurements associated with the manufacturing process that may affect the identity, strength, quality, potency, and purity of a product. Examples of parameters of concern include bioburden, process rate, weight, volume, temperature, and pressure. (TR13)

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)

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)

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)

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). (TR60-3)

An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. (TR60-2)

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)

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)

The second stage of process qualification. It includes a combination of the actual facility, utilities, equipment, and trained personnel and 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. (TR60-3)

A written plan preapproved by the quality unit that specifies critical steps, controls, and measurements. The process performance qualification protocol states how process performance qualification or other validation studies 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. (TR60)

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. (TR60)

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)

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

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

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

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

A discrete step or manipulation in a manufacturing process where process and operating parameters are defined to achieve a specific process objective.(TR60-3)

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)

The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or drug substance meeting its predetermined specifications and quality attributes (1, 17). (TR60-3)

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)

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)

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)

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)

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)

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

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

The characterization of quality attributes, such as peptide map, glycosylation, chromatography pro­file, molecular weight, gel chromatogram, poly­morphs, etc. (TR56)

A complaint by a customer is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a product on the market. Complaint Systems are used to collect and categorize information on the condition of regulated products on the market with which consumers are dissatisfied. (TR55) (TR67)

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)

Product recalls are actions taken by a firm to remove or correct one or more batches of product from the market that are considered to be in violation of one or more laws or rules in that country. Recalls may be conducted on a firm’s own initiative, by Regulatory Agency request, or by order under statuatory authority. These drug recall classifications are specified by the FDA. (TR55)

A microorganism that can adversely affect the appearance, physicochemical attributes or therapeutic effect of a nonsterile product. (TR67)

The process flow in which a product is manufactured.(TR43)

The process flow in which a product is manufactured that is often described in a process map.(TR 76)

A sterilization design approach that is based on the characteristics of the bioburden (on or in the load) and the heat sensitivity of the product that delivers the lethality needed to achieve a PNSU of 10^-6 on or in the items to be sterilized. (TR01) (TR3) (TR30)

A digital electronic apparatus with a programmable memory for storing instructions to implement specific functions, such as logic, sequencing, timing, counting and arithmetic, to control machines and processes. (TR48)

A device that is designed for precise positioning and continuous movement, typically in response to a varying analog signal. [Synonym: Modulating Valve] (TR48)

Control action in which the output is proportional to a linear combination of the input, the time integral of input, and the time rate-of-change of input. (TR48)

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)

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)

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)

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

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)

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 (8). (TR60-3)

Pound-force per square-inch differential is the difference in pressure; for example, the pressure differential between the upstream (influent) and downstream (effluent) sides of a filter. (TR75)

A class of UV photoactivated chemicals able to covalently modify nucleic acids. Psoralens may be used to reduce contaminating nucleic acid in NAT reagents. (TR50)

Any substance capable of eliciting a febrile (or fever) response upon injection or infection (as in endotoxin released in vivo by Gram-negative bacteria. (TR3)

Fever-producing substance (TR69)

A material that elicits a pyrogenic response (fever). (TR70)