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 (62)
- TR 1: Validation: Moist Heat (39)
- TR 60: Process Validation (34)
- TR 3: Validation: Dry Heat (32)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (31)
- TR 48: Moist Heat Sterilizer Systems (27)
- TR 56: Phase Appropriate cGMP Application (25)
- TR 58: Temp Controlled Distribution (25)
- TR 70: Cleaning/Disinfection Programs (25)
- TR 14: Validation: Protein Purification Chromatography (25)
- TR 54: QRM:Manufacturing Operations (24)
- TR 57-2: Analytical Method Development (23)
- TR 61: Steam in Place (22)
- TR 29: Validation: Cleaning (21)
- TR 44: QRM: Aseptic Processes (21)
- TR 54-2: QRM: Packaging Labeling (20)
- TR 64: Temp Controlled Systems Qualification (20)
- TR 45: Depth Filtration (20)
- TR 41: Virus Filtration (18)
- TR 50: Alt. Methods Mycoplasma Testing (17)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (16)
- TR 30: Parametric Release (16)
- TR 51: Biological Indicators (15)
- TR 26: Sterilizing Filtration of Liquids (15)
- TR 42: Validation: Protein Manufacturing (15)
- TR 62: Manual Aseptic Processes (14)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (14)
- TR 33: Rapid Micro Methods (14)
- TR 47: Virus Spikes/Virus Clearance (13)
- TR 43: Glass Defects (13)
- TR 54-4: QRM: Biotech Drug Substance (12)
- TR 55: TBA/TCA Detection Mitigation (12)
- TR 22: Aseptic Process Simulation (12)
- TR 67: Objectionable Microorganisms (11)
- TR 49: Validation: Cleaning Biotech (10)
- TR 74: Reprocessing of Biopharmaceuticals (10)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (10)
- TR 54-3: QRM: Drug Products (9)
- TR 69: Bioburden/Biofilm Management (9)
- TR 15: Validation: TFF in Biopharmaceuticals (9)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (9)
- TR 28: Process Simulation for Bulk API (9)
- TR 68: Drug Shortage Management (8)
- TR 13: Environmental Monitoring (8)
- TR 39: Cold Chain (8)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (7)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (6)
- TR 63: Clinical Trials Material Preparation (5)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (5)
- TR 52: Supply Chain GDP (4)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (4)
- TR 53: Stability Testing New Drug Products (3)
- TR 66: Single-Use Systems (3)
- TR 46: Good Distribution: Last Mile (2)
- TR 65: Technology Transfer (2)
- TR 71: Emerging Methods for Virus Detection (2)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (2)
- TR 81: Cell-Based Therapy Control Strategy (2)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 82: Low Endotoxin Recovery (1)
Filter By Technical Report Keyword
- Manufacturing (432)
- Quality Risk Management/QRM (306)
- GMP/Good Manufacturing Processes/cGMP (294)
- Microbiology (165)
- Technology Transfer (165)
- Sterile Processing (163)
- Biotechnology (151)
- Packaging Science (52)
- Supply Chain (45)
- Filtration (36)
- Virus (34)
- Inspections (28)
- Prefilled Syringes/PFS (20)
- Combination Products (16)
- Outsourcing (11)
- Visual Inspection (9)
- Vaccines (5)
- Lyophilization (2)
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AOAC International (Association Official Analytical Communities)
Serves communities of the analytical sciences by providing the tools and processes necessary to develop voluntary consensus standards or technical standards through stakeholder consensus and working groups in which the fit-for-purpose and method performance criteria are established and fully documented. (TR55)
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Acceptable Daily Exposure
A dose that is unlikely to cause an adverse effect if an individual is exposed, by any route, at or below this dose every day for a lifetime. (TR29)
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Acceptable Daily Intake
An amount of a substance consumed on a daily basis that is considered at a safe level. (TR29) An amount of a substance administered or consumed on a daily basis that is considered a safe level. (TR49)
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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 Criteria
Numerical limits, ranges, or other suitable measures for acceptance of test results. (TR 14) (TR 29) (TR 38) (TR 64)
Numerical limits, ranges, or other suitable measures for acceptance of test results. Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation. Exceeding the operating range should be documented and explained in the validation report and evaluated for validation study impact. (TR 42)
The pre-defined specifications, standards or ranges that must be met under stated test conditions. (TR 48)
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical method validation that is satisfied to determine suitability of test method performance.(TR 57) (TR 69) (TR 72) (TR 74)
The criteria that a system or component must satisfy in order to be accepted by a user or other authorized entity. (TR 54-5)
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet (16). Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation and possible batch rejection. (TR60)
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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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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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BLAST
Basic Local Alignment Search Tool; a bioinformatics algorithm for the comparison of sequence data (e.g., translated amino acids [tBLASTx], proteins [BLASTx], or nucleotides [BLASTn]). (TR 71)
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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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Blank
Analytical sample taken to establish background value for the analytical measurement which may be subtracted from an experimental value to determine the “true” value. (TR29) (TR49)
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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)