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.
(Please select "All" to restart a filtered Search)
Refine Results
Filter By Technical Report Number
- TR 57: Analytical Method Validation (9)
- TR 70: Cleaning/Disinfection Programs (9)
- TR 47: Virus Spikes/Virus Clearance (7)
- TR 62: Manual Aseptic Processes (6)
- TR 22: Aseptic Process Simulation (5)
- TR 51: Biological Indicators (4)
- TR 57-2: Analytical Method Development (4)
- TR 69: Bioburden/Biofilm Management (4)
- TR 50: Alt. Methods Mycoplasma Testing (3)
- TR 61: Steam in Place (3)
- TR 3: Validation: Dry Heat (3)
- TR 14: Validation: Protein Purification Chromatography (3)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (3)
- TR 29: Validation: Cleaning (3)
- TR 41: Virus Filtration (3)
- TR 45: Depth Filtration (3)
- TR 49: Validation: Cleaning Biotech (2)
- TR 55: TBA/TCA Detection Mitigation (2)
- TR 1: Validation: Moist Heat (2)
- TR 13: Environmental Monitoring (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (2)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 63: Clinical Trials Material Preparation (1)
- TR 67: Objectionable Microorganisms (1)
- TR 71: Emerging Methods for Virus Detection (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 82: Low Endotoxin Recovery (1)
- TR 28: Process Simulation for Bulk API (1)
- TR 30: Parametric Release (1)
- TR 33: Rapid Micro Methods (1)
- TR 43: Glass Defects (1)
Filter By Technical Report Keyword
Filter By Technical Report Category
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)
Source:
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)
Source:
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)
Source:
Airlock
A room that controls the airflow between two rooms of different classification. (TR 70)
Source:
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)
Source:
Anaerobe
An organism that has the ability to grow in the absence of oxygen. (TR51)
Source:
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)
Source:
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)
Source:
Analytical Control
Material used to monitor the performance of a method to assess the integrity and validity of the results. (TR57-2)
Source:
Analytical Instrument Qualification (AIQ)
The qualification of the analytical instrument(s) used as part of the analytical procedure. (TR57)
Source:
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)
Source:
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)
Source:
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)
Source:
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)
Source:
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)
Source:
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)
Source:
Aseptic Processing Simulation (APS)
A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)
Source:
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)
Source:
Biological Activity
Property that describes the specific ability or capacity of a product to achieve a defined biological effect. (TR57)
Source:
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)
Source:
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)
Source:
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)
Source:
Biological Tests
Biological tests include animal, cell culture, or biochemical based testing that measures a biological, biochemical, or physiological response. (TR38)
Source:
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)
Source:
Chemistry Manufacturing and Controls (CMC)
The body of information that defines the technical development, manufacturing facility and support utilities; the process equipment and materials used in manufacturing; the manufacturing process itself; the personnel involved in manufacturing and quality; the chemistry of the product; QC in process and release testing, specifications, and stability of the product; all of the controls, documentation, and training necessary to ensure that all of these listed activities are properly and effectively carried out. (TR56)
Source:
Contaminant
Any adventitiously or externally introduced material(s) (e.g., chemical, biochemical, or microbial species) not intended to be part of the process. (TR14) (TR15) (TR70)
An undesired impurity of a chemical or microbiological nature that is introduced into a raw material, intermediate, or API (drug substance) during manufacture. (TR14) (TR15)
Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product. (TR69) (TR74)
Any adventitiously introduced material (e.g., chemical, biochemical) or microorganisms including viruses not intended to be included in the manufacturing process of the drug substance or drug product. (TR83)
Source:
Contamination Rate
The percentage of units filled in a process simulation that are positive for microbial growth after incubation. (TR22)
Source:
Correlation Coefficient ( r )
A measure of covariation, the square root of the coefficient of determination. (TR57)
Source:
Coupon
A small, generally flat portion of a defined material of construction (such as stainless steel or PTFE) and of a defined surface finish, typically used for laboratory cleaning evaluations and/or for laboratory sampling recovery studies. (TR29) (TR49)
Source:
Critical Process (CP)
A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.
Source:
Cytopathic Effect (CPe)
Morphological changes induced by viruses in infected cells in invitro culture. They are usually localized around a site of initial infection and vary in appearance based on the virus and the cultured cell. (TR47)
Source:
Cytopathic Virus
Viruses where infection of cells results in microscopically visible degeneration of the cells or other morphological changes. (TR47)
Source:
Decontamination
A process that is designed to remove soil (including microorganisms) and may consist of cleaning and/or disinfection. (TR51)
Source:
Depyrogenation
The destruction and/or removal of bacterial endotoxins. A depyrogenation process should demonstrate at least 99.9% or a 3-log endotoxin reduction. (TR3) Removal or destruction of pyrogens. (TR70)
Source:
Dynamic Light Scattering (DLS)
A technique used to measure the size and size distribution of particles. Particles suspended in a solution will cause scattering of light and the extent of the scattering is related to the size and shape of the particles. (TR47)
Source:
Endogenous Virus
A virus that pre-exists in the genome of the cell substrate. (TR71)
A virus that integrates into the genome of the cell substrate. (TR83)
Source:
Endogenous Virus-Like Particles – (e.g., Type C endogenous retroviruses)
Virus-like entity whose genetic material is stably integrated into the germ line of an organism or cell line. Cell lines (notably CHO) may constitutively produce virus-like particles, which are typically noninfectious but still of safety concern. Model retroviruses are generally used as surrogates to measure virus-like particle clearance. (TR41)
Source:
Endotoxin Indicator (EI) for Depyrogenation
An article challenged with a vial of endotoxin (or a carrier spiked with endotoxin) designed for use in depyrogenation studies. The endotoxin (a purified lipopolysaccaride) is validated for use in or on an endotoxin indicator. The carrier is made from a material appropriate for the intended depyrogenation processes to which it will be subjected. The endotoxin on a carrier is added at a concentration sufficient to allow recovery of a minimum of 1000 USP endotoxin units/carrier. The endotoxin indicator would allow for accurate indication of at least a 3-log reduction in USP endotoxin units during depyrogenation process challenges. (TR3)
Source:
Endpoint PCR
A classical PCR method based on repeated cycling of the reaction mixture between two or three temperatures (denaturing, annealing, and extension) with detection of the amplified product after reaction completion (e.g., by agarose gel electrophoresis). (TR50)
Source:
Environmental Flora (isolates)
Microorganisms associated with a processing environment. (TR22)
Source:
Environmental Monitoring (EM)
Describes the processes and activities that need to take place to characterize and monitor the quality of the environment. (TR70)
Monitoring for nonviable particulates and/or microorganisms where the result meets or exceeds the alert and/or action level or limit. (TR88)
Source:
Environmental Monitoring Program
Defined documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas, and includes a corrective action plan when action levels are exceeded. It includes assessment of environmental air, surfaces and personnel. (TR22) (TR28) (TR62)
Source:
Fastidious strain (isolate)
A population of microorganisms having complex nutritional requirements and thus difficult to cultivate. (TR50)
Source:
Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
Source:
First Air
Refers to the air exiting at the face of HEPA filters. Based on the airflow through HEPA filters and its unidirectional air flow the air exiting at the filter face is for the purposed of aseptic processing free of particulate contamination (both viable and non-viable). (TR70)
Source:
First Air (First Work Location)
The work location first in the path of HEPA filtered air. (TR62)
Source:
Free Drained Equipment
No visible water pool in the equipment or line when viewed under appropriate lighting conditions (but may contain water droplets). (TR29)
Source:
High-Efficiency Particulate Air (HEPA) Filter
A type of air filter that must satisfy certain standards of efficiency such as those set by the United States Department of Energy (DOE). The air filter must remove 99.97% of all particles greater than 0.3 micrometer from the air that passes through it. (TR62) (TR70)
Source:
Inclusivity
The ability of an assay to detect a target microorganism. (TR33)
Source:
Intrinsic Particles
Those particles that arise from sources related to the formulation, packaging, or assembly processes. In each of these cases, the particle material (e.g., glass, stainless steel, rubber, or gasket material) could be identified as a known product-contact material. (TR78)
A particle that comes from within the primary process. These are qualified product contact materials and are often associated with the primary packaging components. They are unplanned but not unexpected.(TR85)