PDA Technical Glossary
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.
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- TR 56: Phase Appropriate cGMP Application (14)
- TR 70: Cleaning/Disinfection Programs (14)
- TR 60: Process Validation (13)
- TR 14: Validation: Protein Purification Chromatography (11)
- TR 54: QRM:Manufacturing Operations (10)
- TR 62: Manual Aseptic Processes (10)
- TR 54-4: QRM: Biotech Drug Substance (9)
- TR 57: Analytical Method Validation (9)
- TR 67: Objectionable Microorganisms (9)
- TR 69: Bioburden/Biofilm Management (9)
- TR 22: Aseptic Process Simulation (9)
- TR 45: Depth Filtration (9)
- TR 50: Alt. Methods Mycoplasma Testing (8)
- TR 51: Biological Indicators (8)
- TR 55: TBA/TCA Detection Mitigation (8)
- TR 15: Validation: TFF in Biopharmaceuticals (8)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (7)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (7)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (7)
- TR 54-2: QRM: Packaging Labeling (6)
- TR 54-3: QRM: Drug Products (6)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (6)
- TR 48: Moist Heat Sterilizer Systems (5)
- TR 58: Temp Controlled Distribution (5)
- TR 61: Steam in Place (5)
- TR 66: Single-Use Systems (5)
- TR 26: Sterilizing Filtration of Liquids (5)
- TR 28: Process Simulation for Bulk API (5)
- TR 63: Clinical Trials Material Preparation (4)
- TR 74: Reprocessing of Biopharmaceuticals (4)
- TR 1: Validation: Moist Heat (4)
- TR 3: Validation: Dry Heat (4)
- TR 13: Environmental Monitoring (4)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (4)
- TR 41: Virus Filtration (4)
- TR 47: Virus Spikes/Virus Clearance (3)
- TR 82: Low Endotoxin Recovery (3)
- TR 29: Validation: Cleaning (3)
- TR 30: Parametric Release (3)
- TR 42: Validation: Protein Manufacturing (3)
- TR 43: Glass Defects (3)
- TR 44: QRM: Aseptic Processes (3)
- TR 52: Supply Chain GDP (2)
- TR 53: Stability Testing New Drug Products (2)
- TR 57-2: Analytical Method Development (2)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (2)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (2)
- TR 33: Rapid Micro Methods (2)
- TR 49: Validation: Cleaning Biotech (1)
- TR 68: Drug Shortage Management (1)
- TR 71: Emerging Methods for Virus Detection (1)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 81: Cell-Based Therapy Control Strategy (1)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (1)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (1)
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- Quality Risk Management/QRM (100)
- Validation (81)
- Microbiology (68)
- Sterile Processing (65)
- Packaging Science (32)
- Technology Transfer (27)
- Combination Products (26)
- Inspections (23)
- Supply Chain (18)
- Filtration (16)
- Virus (13)
- Prefilled Syringes/PFS (11)
- Vaccines (6)
- Outsourcing (3)
- Visual Inspection (3)
- Lyophilization (1)
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Action Plan
A written plan consisting of elements to be accomplished to achieve a specific result. The plan describes responsibility for each element and a target date for completion. (TR22)
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Active Pharmaceutical Ingredient (API)
Synonym: Drug Substance. (TR14) (TR42) A substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. (TR54-4) Any substance or mixture of substance intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Note: also known as Drug Substance. (TR29) (TR56) (TR41) (TR54-3) (TR60) Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity o other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body. (TR63) (TR70) Any substance or mixture of substances intended to be used in the manufacture of a drug product, and that when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body. (TR74)
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Active Pharmaceutical Ingredient (API) Equivalent to Drug Substance for large molecules
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. (TR60)
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Active Pharmaceutical Ingredient (API) Starting Material
A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials normally have defined chemical properties and structures. (TR60)
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Active Pharmaceutical Ingredient (API) or (Drug substance)
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and when used in the production of a drug, becomes an active ingredient of the drug product (also called “drug substance”). (TR29) Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. (TR54-3) Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body. (TR63)
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Adverse Event (AE) Report
An AE report is a communication to the U.S. FDA of an undesirable sign or symptom associated with use of a drug as required and detailed by 21 CFR 314.80. These reports are logged into the U.S. FDA’s Adverse Event Reporting System (AERS). Drug manufacturers are required to report adverse event information to FDA. These reports may also may be voluntarily submitted to the FDA directly by healthcare professionals or the general public at Med Watch. The reports are reviewed, safety issues are monitored, and data are periodically analyzed and assessed by the Center for Drug Evaluation and Research (CDER). (TR55)
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Adverse Trend
A series of alert-level or action-level excursions that indicates the system or areas are not in control and have the potential to affect the product quality. (TR 70)
An increase in the frequency of alert- and action-level excursions or repeated recovery of low levels of microorganisms below the alert level during microbial monitoring or of pharmaceutical ingredient or finished product failure that is indicative of a loss of process control. (TR88)
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Aggregation
Clumping of proteins, viruses, or bacteria that may arise from several mechanisms and may be classified in numerous ways, including soluble/insoluble, covalent/noncovalent, reversible/irreversible, and native/denatured. (TR47)
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Air Removal Test
A test used to evaluate air removal and steam penetration in an empty sterilizer that is used for porous/hard goods load sterilization (e.g., Bowie-Dick Test, DART, Lantor Cube, Browns’ Test). (TR01) (TR 48)
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Airlock
A room that controls the airflow between two rooms of different classification. (TR 70)
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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)
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Anisotropic (Asymmetric) Membrane
A membrane in which the pore size and structure differ from one face to the other. These membranes are usually considered “directional” because of the difference in flow characteristics, depending on which surface of the membrane faces the feed stream. (TR15)
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Antimicrobial Chemical Agent
Substance used to destroy or suppress the growth of microorganisms, whether bacteria, fungi, or viruses, on inanimate objects and surfaces. (TR70)
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Area Disinfection
Disinfection of floors, walls, ceilings, and other surfaces. (TR70)
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Aseptic Processing
Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR28) (TR62) (TR69) Handling of sterile product, containers, and/ or devices in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to maintain (product) sterility. (TR13)
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Aseptic Processing Area (APA)
Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)
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Aseptic Processing Simulation (APS)
A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)
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Attribute
A physical, chemical, or microbiological property or characteristic of an input or output material. (TR60)
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Attributes (Process Performance Attribute)
An output variable or outcome that cannot be directly controlled, but is an indicator that the process performed as expected.(Synonym - Process Performance Parameter) (TR60)
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Attributes (Quality Attribute)
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)
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Bioburden
The total number of microorganisms per unit of material prior to sterilization. (TR13) Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62) A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26) A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70) The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47) The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51) Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)
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Biological Active Substance
Manufactured biological active substances and medicinal products involving biological processes and materials, such as cultivation of cells or extraction from living organisms. (TR56)
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Biological Activity
Property that describes the specific ability or capacity of a product to achieve a defined biological effect. (TR57)
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Biological Indicator (BI)
An inoculated carrier contained within its primary pack ready for use and providing a defined resistance to the specified sterilization process. (TR51)
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Biological Medicinal Product
A product (therapeutic or prophylactic) for human use that has been manufactured in or from a biological source. Examples include recombinant therapeutic proteins or vaccines. Biological medicinal products are also referred to as: biological medicines, biological products, biologics and biologic drugs. (TR 71)
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Biological Qualification
A component of performance qualification that demonstrates, by use of biological indicators, that the required lethality (FBIO) is achieved consistently throughout the load. (TR1) (TR3) (TR30) A component of performance qualification that demonstrates, by use of biological indicators, that the required lethality (FBIO) or spore log reduction (SLR) is achieved consistently throughout the sterilized or sanitized portion of the SIP system. (TR61)
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Biological Safety Cabinet (BSC)
An enclosed, ventilated workspace with engineering controls designed to remove or minimize exposure to hazardous biological materials. A BSC is a principle device to provide containment of infectious splashes or aerosols generated by many microbiological procedures. BSCs are designed to provide personnel, environmental and product protection when appropriate practices and procedures are followed. A cabinet that is designed to protect the operator and the environment from the hazards of handling infected material and other dangerous biological. (TR62)
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Biological Tests
Biological tests include animal, cell culture, or biochemical based testing that measures a biological, biochemical, or physiological response. (TR38)
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Biologics License Application (BLA)
An application, filed with the US Food and Drug Administration (FDA), which contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical effects of the biologic product (similar function as the Marketing Authorization Application in Europe). (TR56)
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Biomethylation
The enzyme chlorophenol o-methyltransferase responsible for fungal methylation has been isolated in cell-free extracts. Biomethylation, in this context, may be seen as a detoxification mechanism, although it plays a role in the production of mycotoxins by secondary metabolism. Slightly xerophilic fungi frequently associated halophenol biomethylation include Trichoderma longibrachiatum, Trichoderma virgatum, Aspergillus sydowii, and Penicillium islandicum. (TR55)
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Break-loose Force
Energy required to initiate plunger movement within the syringe barrel upon injection. (TR 73)
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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)
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Changeover
The steps taken for switching multiproduct equipment from the manufacture of one product to the manufacture of a different product. (TR29) (TR49)
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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)
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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)
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Chemical Compatibility
The relative stability of filter materials and/or filter assembly components when exposed to process fluids and process parameters. (TR45)
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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)
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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)
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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)
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Clarification
The removal of solid particulates from a liquid through filtration, sedimentation, centrifugation or other means. (TR45)
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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)
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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)
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Clinician
A physician, psychiatrist, etc., who specializes in clinical work as opposed to one engaged in laboratory or experimental studies. (TR58)
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Closed System
An isolated system that has no interaction with its external environment, preventing contamination and release of the material contained.(TR28) (TR 66)
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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)
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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)
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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)
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Comparability Study
An assessment of the similarities between the critical parameters and output results of two or more separate processes or methods. (TR50)
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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)
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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)