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 (28)
- TR 60: Process Validation (25)
- TR 1: Validation: Moist Heat (23)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (23)
- TR 3: Validation: Dry Heat (22)
- TR 56: Phase Appropriate cGMP Application (20)
- TR 70: Cleaning/Disinfection Programs (20)
- TR 54: QRM:Manufacturing Operations (18)
- TR 44: QRM: Aseptic Processes (17)
- TR 48: Moist Heat Sterilizer Systems (16)
- TR 54-2: QRM: Packaging Labeling (16)
- TR 14: Validation: Protein Purification Chromatography (16)
- TR 61: Steam in Place (14)
- TR 62: Manual Aseptic Processes (13)
- TR 30: Parametric Release (13)
- TR 51: Biological Indicators (12)
- TR 58: Temp Controlled Distribution (12)
- TR 43: Glass Defects (11)
- TR 29: Validation: Cleaning (10)
- TR 54-4: QRM: Biotech Drug Substance (9)
- TR 67: Objectionable Microorganisms (9)
- TR 22: Aseptic Process Simulation (9)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (9)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (9)
- TR 42: Validation: Protein Manufacturing (9)
- TR 50: Alt. Methods Mycoplasma Testing (8)
- TR 55: TBA/TCA Detection Mitigation (8)
- TR 57-2: Analytical Method Development (8)
- TR 69: Bioburden/Biofilm Management (8)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (8)
- TR 33: Rapid Micro Methods (8)
- TR 13: Environmental Monitoring (7)
- TR 41: Virus Filtration (7)
- TR 45: Depth Filtration (7)
- TR 54-3: QRM: Drug Products (6)
- TR 64: Temp Controlled Systems Qualification (6)
- TR 26: Sterilizing Filtration of Liquids (6)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (6)
- TR 28: Process Simulation for Bulk API (6)
- TR 49: Validation: Cleaning Biotech (5)
- TR 74: Reprocessing of Biopharmaceuticals (5)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (5)
- TR 68: Drug Shortage Management (4)
- TR 52: Supply Chain GDP (3)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (3)
- TR 15: Validation: TFF in Biopharmaceuticals (3)
- TR 47: Virus Spikes/Virus Clearance (2)
- TR 53: Stability Testing New Drug Products (2)
- TR 63: Clinical Trials Material Preparation (2)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (2)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (2)
- TR 81: Cell-Based Therapy Control Strategy (2)
- TR 65: Technology Transfer (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 39: Cold Chain (1)
Filter By Technical Report Keyword
- Quality Risk Management/QRM (186)
- Sterile Processing (103)
- Microbiology (89)
- Technology Transfer (88)
- Biotechnology (81)
- Packaging Science (28)
- Inspections (25)
- Supply Chain (15)
- Combination Products (14)
- Filtration (9)
- Visual Inspection (8)
- Virus (7)
- Prefilled Syringes/PFS (6)
- Outsourcing (5)
- Vaccines (3)
- 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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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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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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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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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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Calibration Curve
The relationship between measured response values and analytical concentrations of a standard or reference material. (TR57)
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Capsule
A self-contained filter device. (TR45)
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Capsule Filter
Compact, self-contained filter assembly. Generally, the whole assembly is disposable. (TR26) (TR41)
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Carrier
A solid support upon which the test organism used in biological monitoring is inoculated. (TR51)
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Cartridge Filter
Filter elements encased in a housing. Generally, the filter elements are disposable while the housing units are multi-use. In a few cases, both filter and housings are disposable. (TR26) (TR41)
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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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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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Cleaning Validation
Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)
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Cleaning Verification
A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)
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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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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)
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Conformance Batches/Lots
A pre-determined number of production lots, typically three, that represent the process and are evaluated to demonstrate consistency. [Synonyms: validation, consistency, demonstration lots, qualification lots] (TR14) (TR42)
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Contact Time
The minimum amount of time that a sanitizer, disinfectant, or sporicide must be left in complete (wet) contact with the surface to be treated in order to be effective. (TR70)
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Container Closure Integrity (CCI)
The ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards.(TR76)