
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 80: Data Integrity Management System for Pharmaceutical Laboratories (27)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (25)
- TR 54: QRM:Manufacturing Operations (24)
- TR 54-2: QRM: Packaging Labeling (20)
- TR 60: Process Validation (20)
- TR 70: Cleaning/Disinfection Programs (20)
- TR 44: QRM: Aseptic Processes (19)
- TR 56: Phase Appropriate cGMP Application (17)
- TR 58: Temp Controlled Distribution (16)
- TR 3: Validation: Dry Heat (16)
- TR 62: Manual Aseptic Processes (15)
- TR 54-4: QRM: Biotech Drug Substance (14)
- TR 57: Analytical Method Validation (14)
- TR 48: Moist Heat Sterilizer Systems (13)
- TR 67: Objectionable Microorganisms (13)
- TR 22: Aseptic Process Simulation (13)
- TR 51: Biological Indicators (12)
- TR 55: TBA/TCA Detection Mitigation (12)
- TR 1: Validation: Moist Heat (12)
- TR 61: Steam in Place (11)
- TR 14: Validation: Protein Purification Chromatography (10)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (10)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (10)
- TR 43: Glass Defects (10)
- TR 69: Bioburden/Biofilm Management (9)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (9)
- TR 30: Parametric Release (9)
- TR 45: Depth Filtration (9)
- TR 54-3: QRM: Drug Products (7)
- TR 63: Clinical Trials Material Preparation (7)
- TR 13: Environmental Monitoring (7)
- TR 52: Supply Chain GDP (6)
- TR 64: Temp Controlled Systems Qualification (6)
- TR 68: Drug Shortage Management (6)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (6)
- TR 29: Validation: Cleaning (6)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (6)
- TR 41: Virus Filtration (6)
- TR 47: Virus Spikes/Virus Clearance (5)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (5)
- TR 15: Validation: TFF in Biopharmaceuticals (5)
- TR 26: Sterilizing Filtration of Liquids (5)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (5)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (5)
- TR 42: Validation: Protein Manufacturing (5)
- TR 50: Alt. Methods Mycoplasma Testing (4)
- TR 57-2: Analytical Method Development (4)
- TR 28: Process Simulation for Bulk API (4)
- TR 66: Single-Use Systems (3)
- TR 74: Reprocessing of Biopharmaceuticals (3)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (3)
- TR 33: Rapid Micro Methods (3)
- TR 49: Validation: Cleaning Biotech (2)
- TR 65: Technology Transfer (2)
- TR 82: Low Endotoxin Recovery (2)
- TR 81: Cell-Based Therapy Control Strategy (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- TR 39: Cold Chain (2)
- TR 53: Stability Testing New Drug Products (1)
- TR 71: Emerging Methods for Virus Detection (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
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- Manufacturing (271)
- Validation (193)
- Biotechnology (108)
- Sterile Processing (93)
- Technology Transfer (91)
- Microbiology (76)
- Packaging Science (34)
- Inspections (31)
- Supply Chain (19)
- Combination Products (16)
- Virus (15)
- Prefilled Syringes/PFS (11)
- Vaccines (10)
- Filtration (9)
- Visual Inspection (7)
- Outsourcing (6)
- Lyophilization (1)
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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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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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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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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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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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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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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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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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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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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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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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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)
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Bioassay
Analysis (as of a drug) to quantify the biological activity(ies) of one or more components by determining its capacity for producing an expected biological activity. (TR57)
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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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Biofouling (or Biological Fouling)
Accumulation and subsequent deleterious effects of biological contaminants on engineered products or processes (TR 69)
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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 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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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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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)
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Chamber Leak Test
A test conducted to evaluate possible air infiltration to the chamber under vacuum. [Synonym: Vacuum Leak Test] (TR1) (TR48)
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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)
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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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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)
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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)
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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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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)
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Compendial Procedure
A method that is considered validated as published in one of the recognized compendia. (TR57)
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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)
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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)
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Component, Primary
Element of the assembled prefilled syringe (needle, plunger stopper and tip closure, or adhesive) directly in contact with the drug. (TR 73)
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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)
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Composite Membrane
A membrane consisting of multiple layers. (TR15)
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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)