
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 (31)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (24)
- TR 54: QRM:Manufacturing Operations (23)
- TR 58: Temp Controlled Distribution (22)
- TR 60: Process Validation (22)
- TR 44: QRM: Aseptic Processes (21)
- TR 54-2: QRM: Packaging Labeling (20)
- TR 1: Validation: Moist Heat (19)
- TR 3: Validation: Dry Heat (19)
- TR 70: Cleaning/Disinfection Programs (18)
- TR 56: Phase Appropriate cGMP Application (17)
- TR 64: Temp Controlled Systems Qualification (17)
- TR 48: Moist Heat Sterilizer Systems (14)
- TR 61: Steam in Place (14)
- TR 57-2: Analytical Method Development (13)
- TR 51: Biological Indicators (12)
- TR 54-4: QRM: Biotech Drug Substance (12)
- TR 62: Manual Aseptic Processes (12)
- TR 14: Validation: Protein Purification Chromatography (12)
- TR 45: Depth Filtration (11)
- TR 22: Aseptic Process Simulation (10)
- TR 29: Validation: Cleaning (10)
- TR 30: Parametric Release (10)
- TR 54-3: QRM: Drug Products (9)
- TR 67: Objectionable Microorganisms (9)
- TR 43: Glass Defects (9)
- TR 47: Virus Spikes/Virus Clearance (8)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (8)
- TR 42: Validation: Protein Manufacturing (8)
- TR 50: Alt. Methods Mycoplasma Testing (7)
- TR 55: TBA/TCA Detection Mitigation (7)
- TR 68: Drug Shortage Management (7)
- TR 13: Environmental Monitoring (7)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (7)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (7)
- TR 69: Bioburden/Biofilm Management (6)
- TR 28: Process Simulation for Bulk API (6)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (6)
- TR 39: Cold Chain (6)
- TR 41: Virus Filtration (6)
- TR 49: Validation: Cleaning Biotech (5)
- TR 74: Reprocessing of Biopharmaceuticals (5)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (5)
- TR 52: Supply Chain GDP (4)
- TR 63: Clinical Trials Material Preparation (4)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (4)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (4)
- TR 15: Validation: TFF in Biopharmaceuticals (4)
- TR 33: Rapid Micro Methods (4)
- TR 26: Sterilizing Filtration of Liquids (3)
- TR 53: Stability Testing New Drug Products (2)
- TR 65: Technology Transfer (2)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (2)
- TR 81: Cell-Based Therapy Control Strategy (2)
- TR 46: Good Distribution: Last Mile (1)
- TR 66: Single-Use Systems (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
Filter By Technical Report Keyword
- Manufacturing (274)
- GMP/Good Manufacturing Processes/cGMP (193)
- Biotechnology (118)
- Technology Transfer (106)
- Sterile Processing (92)
- Microbiology (84)
- Supply Chain (39)
- Packaging Science (36)
- Inspections (19)
- Prefilled Syringes/PFS (18)
- Virus (14)
- Filtration (11)
- Combination Products (9)
- Outsourcing (8)
- Visual Inspection (6)
- Vaccines (5)
- 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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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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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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Ambient Temperature
The air temperature of an environment. (TR58)
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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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Analysis of Variance (ANOVA)
A general statistical approach to data analysis (i.e., comparison of means) in which the variation in a method’s results is partitioned among explanatory factors in order to systematically assess factor influence and/or variance components. (TR57)
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Analyte
Substance (usually a residue) for which an analysis is being performed. (TR29) (TR49) (TR70) A specific chemical moiety being measured, which can be intact drug, biomolecule or its derivative, impurity, and/or excipients in a drug product. [Synonym: measurand] (TR57)
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Analytical Control
Material used to monitor the performance of a method to assess the integrity and validity of the results. (TR57-2)
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Analytical Instrument Qualification (AIQ)
The qualification of the analytical instrument(s) used as part of the analytical procedure. (TR57)
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Analytical Method Comparability (AMC)
Equivalence study that measure the same property of two methods and that shows that replacing one of these methods with the other would not adversely affect the test’s use or results. (TR57-2)
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Analytical Method Design
Collection of activities performed to define the intended purpose of the method, select the appropriate technology to implement the method, and identify the critical method variables that need to be controlled to ensure that the method is robust and rugged. (TR57-2)
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Analytical Method Development (AMD)
Collection of activities performed to select an appropriate technique and method conditions to meet the Analytical Target Profile (ATP) requirements. (TR57-2)
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Analytical Method Transfer (AMT)
Documented process that qualifies a laboratory (receiving unit) to use an analytical test procedure that originates in another laboratory (the transferring unit, also known as the sending unit), thus ensuring that the receiving unit has the knowledge and ability to perform the transferred analytical procedure as intended. (TR57-2)
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Analytical Platform Technology (APT)
An analytical method that is used for multiple products and/or types of sample matrix without modification of the procedure. Similar to compendial methods, an APT method may not require full validation for each new product or sample type. (TR57)
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Analytical Procedure
That which is performed in order to obtain a reportable result. The procedure should describe in detail the steps necessary to perform the analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generations of the calibration curve, use of the formulae for the calculation [Synonym: Method, Assay] (TR57)
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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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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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British Thermal Unit (BTU)
The amount of heat (measured in Joules) required to raise the temperature of one pound of
water by 1ºF.(TR64)
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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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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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Cold Chain
A temperature- and time-controlled supply chain for products (e.g., refrigerated products typically have a temperature storage range of 2 °C to 8 °C). (TR58)
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Cold Chain Tolerance Groups
This concept expands the “normal” definition of cold chain to include all products that need to be stored below 250C and also introduces the ancillary terms “ambient temperatures” and “controlled ambient”. (TR46)
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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)