
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 57: Analytical Method Validation (52)
- TR 1: Validation: Moist Heat (48)
- TR 26: Sterilizing Filtration of Liquids (47)
- TR 45: Depth Filtration (46)
- TR 48: Moist Heat Sterilizer Systems (37)
- TR 70: Cleaning/Disinfection Programs (37)
- TR 3: Validation: Dry Heat (36)
- TR 14: Validation: Protein Purification Chromatography (36)
- TR 60: Process Validation (33)
- TR 15: Validation: TFF in Biopharmaceuticals (33)
- TR 58: Temp Controlled Distribution (31)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (31)
- TR 54: QRM:Manufacturing Operations (30)
- TR 80: Data Integrity Management System for Pharmaceutical Laboratories (29)
- TR 41: Virus Filtration (29)
- TR 61: Steam in Place (28)
- TR 56: Phase Appropriate cGMP Application (26)
- TR 51: Biological Indicators (25)
- TR 54-2: QRM: Packaging Labeling (25)
- TR 55: TBA/TCA Detection Mitigation (25)
- TR 44: QRM: Aseptic Processes (24)
- TR 67: Objectionable Microorganisms (23)
- TR 29: Validation: Cleaning (21)
- TR 50: Alt. Methods Mycoplasma Testing (20)
- TR 62: Manual Aseptic Processes (20)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (20)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (20)
- TR 57-2: Analytical Method Development (18)
- TR 64: Temp Controlled Systems Qualification (18)
- TR 69: Bioburden/Biofilm Management (18)
- TR 13: Environmental Monitoring (18)
- TR 22: Aseptic Process Simulation (18)
- TR 30: Parametric Release (18)
- TR 54-4: QRM: Biotech Drug Substance (17)
- TR 43: Glass Defects (17)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (15)
- TR 42: Validation: Protein Manufacturing (15)
- TR 63: Clinical Trials Material Preparation (14)
- TR 68: Drug Shortage Management (14)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (14)
- TR 33: Rapid Micro Methods (14)
- TR 66: Single-Use Systems (13)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (12)
- TR 39: Cold Chain (12)
- TR 54-3: QRM: Drug Products (11)
- TR 74: Reprocessing of Biopharmaceuticals (11)
- TR 28: Process Simulation for Bulk API (11)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (10)
- TR 47: Virus Spikes/Virus Clearance (9)
- TR 49: Validation: Cleaning Biotech (9)
- TR 46: Good Distribution: Last Mile (7)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (7)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (7)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (7)
- TR 82: Low Endotoxin Recovery (7)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (7)
- TR 52: Supply Chain GDP (5)
- TR 65: Technology Transfer (5)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (5)
- TR 53: Stability Testing New Drug Products (3)
- TR 75: Mycoplasma Filter Rating Method (3)
- TR 71: Emerging Methods for Virus Detection (2)
- TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (2)
- TR 81: Cell-Based Therapy Control Strategy (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (2)
Filter By Technical Report Keyword
- GMP/Good Manufacturing Processes/cGMP (459)
- Validation (432)
- Quality Risk Management/QRM (404)
- Sterile Processing (269)
- Biotechnology (253)
- Microbiology (217)
- Technology Transfer (195)
- Packaging Science (115)
- Filtration (110)
- Supply Chain (92)
- Inspections (51)
- Combination Products (41)
- Outsourcing (37)
- Virus (33)
- Prefilled Syringes/PFS (30)
- Visual Inspection (23)
- Vaccines (9)
- Lyophilization (4)
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Acceptable Quality Limit (AQL)
The quality level that is the worst-tolerable process average when a continuing series of lots are submitted for acceptance sampling. (TR43) (TR 76)
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Acceptable Range
The extent to which, or the limits between which, acceptable variation exists.(TR38)
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Acceptance Limit
The maximum amount of residue allowed in a product, in an analytical sample, or as an amount per surface area. (TR29)
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Accuracy
The closeness of the actual test results obtained by the new method to the actual test results obtained by the existing method. (TR33) An analytical procedure expresses the closeness of agreement between the value that is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness. (TR57)
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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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Active Systems
Systems with active temperature control (e.g., air/sea freight containers, refrigerated trucks/cars). (TR39) System with active temperature control. It makes use of electricity or fuel for the compressor to maintain temperature. Examples include refrigerated trucks, temperature-controlled ocean containers, and active ULDs. (TR58) Actively powered system that uses electricity or other fuel source to maintain a temperaturecontrolled environment inside an insulated enclosure under thermostatic regulation (e.g., cold room, refrigerator, temperature-controlled truck, refrigerated ocean or air container). (TR64) (TR72) (Synonym: Active Temperature Controlled System)
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Active Temperature Controlled System
Actively powered system that uses electricity or other fuel source to maintain a temperaturecontrolled environment inside an insulated enclosure under thermostatic regulation (e.g., cold room, refrigerator, temperature-controlled truck, refrigerated ocean or air container). (TR 72) (TR64)
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Active Unit Load Device (Active ULD)
A Unit Load Device (ULD) container used to consolidate cargo on aircraft that contains electrical or battery-powered temperature control systems for transporting temperature-sensitive materials; an RKN type is used in an FMEA example. (TR58) A unit load device with an active heating and/or cooling system that is typically used in air transportation, usually operated from externally supplied AC or DC power or from internal batteries. (TR64)
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Active Unit Load Device (ULD)
A Unit Load Device (ULD) container used to consolidate cargo on aircraft that contains electrical or battery-powered temperature control systems for transporting temperature-sensitive materials; an RKN type is used in an FMEA example. (TR58) A unit load device with an active heating and/or cooling system that is typically used in air transportation, usually operated from externally supplied AC or DC power or from internal batteries. (TR 64)
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Activity
Ability of endotoxin (LPS) to initiate the LAL cascade in the compendial bacterial endotoxins test (BET) assay, or the ability to elicit a pyrogenic response in a compendial pyrogen test (2,10). Activity can be measured by other assays such as the monocyte activation test (MAT) or recombinant Factor C tests (rFc), if such tests have been validated, to demonstrate that decisions made from the results are comparable to or superior to the compendial assay. Activity is measured in endotoxin units (EU). In terms of activity, one EU = one IU, regardless of the source. Activity is generally expressed as a concentration, usually EU/mL.(TR82)
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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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Airborne Particulate Count (Total Particulate Count)
The total number of particles of a specific size per unit volume of air. (TR13)
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Airborne Viable Particulate Count (Total Airborne Aerobic Microbial Count)
The total number of particles of a specific size per unit volume of air. (TR13)
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Airlock
A room that controls the airflow between two rooms of different classification. (TR 70)
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Amplicon
A segment of double stranded DNA formed as the product of polymerase chain reaction or other amplification based techniques such as TMA or NASBA. (TR50)
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Anaerobe
An organism that has the ability to grow in the absence of oxygen. (TR51)
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Anaerobic Microorganism
A microorganism that does not utilize oxygen as the final electron acceptor during metabolism; microorganism that will grow only in the absence of oxygen. (TR62)(TR22)
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Ancillary Packaging Components/Systems
Additional means used in combination with the basic transportation unit to maintain the required temperature during transport. Examples include active systems and passive systems. (TR39)
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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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Animal-Derived Raw Materials (Tertiary)
Sourced from synthetic components but includes animal-derived components used during the manufacture of the raw material that do not come in direct contact with the raw material, for example, polymers or elastomers used in process equipment or plumbing that may contain or may have been exposed to animal-sourced materials such as stearates or slip agents. (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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Annual Product Review
GMP-mandated evaluation of the standards for each active pharmaceutical ingredient (API), drug product or biologics to determine the need for changes in drug product specifications and/ or manufacturing, control procedures or manufacturing processes. (TR54-5)
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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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Archival (MHRA )
A designated secure area or facility (e.g., cabinet, room, building or computerised system) for the long-term retention of data and metadata for the purposes of verification of the process or activity.(TR80)
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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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Aspect Ratio
The length of a particle or fiber divided by its width. (TR85)
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Assess the Effects of the Change
To evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a drug product as those factors may relate to the safety or effectiveness of the drug product. (TR38)
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Attachment (Adhesion)
Discrete association of a microorganism with an animate or inanimate surface. (TR69)
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Attribute
A physical, chemical, or microbiological property or characteristic of an input or output material. (TR60)
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Attribute Sampling
Inspection where either the unit of product is classified as conforming or non-conforming or the number of non-conformities in the unit of products is counted with respect to a given requirement of set of requirements. (TR43)
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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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Audit Trail (WHO)
The audit trail is a form of metadata that contains information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions, or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record.(TR80)
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Autoclave
A chamber for steam sterilization. (TR45)
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Back Pressure
Residual pressure opposing the free flow of liquid or gas at the outlet side of the filter. (TR45) Pressure applied downstream of a filter or other piece of equipment. (TR26)
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Backup (MHRA)
A copy of current (editable) data, metadata and system configuration settings maintained for recovery including disaster recovery.(TR80)
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Backup (WHO)
A copy of one or more electronic files created as an alternative in case the original data or system are lost or become unusable. Backup differs from archival in that back-up copies of electronic records are typically only temporarily stored for the purposes of disaster recovery and may be periodically overwritten. Such temporary back-up copies should not be relied upon as an archival mechanism.(TR80)
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Batch Record Review
Review by the quality control unit of the batch manufacturing record for accuracy and completeness and for absence of derivation from the approved manufacturing and testing processes. The batch record is inclusive of all in-process testing and release records for a batch. (TR88)
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Bias
A systematic difference in a method that manifests itself as a deviation of the method mean from an expected value. (TR57) Total systematic error, in contrast to random error. Measurement centered on the true result is said to be unbiased or have no systematic error. The distance between the center of a large (infinite) number of measurements and the correct value is the bias. (TR 57-2)
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Bioanalytical Test Method
A method used to assess the presence of analytes (chemical or biological) in biological samples (e.g., serum, plasma, etc.). (TR57)