Home / PDA Technical Glossary

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

Filter By Technical Report Keyword

Filter By Technical Report Category

Displaying results 1 - 50 of 103

Action Level

An established microbial or airborne particle level that, when exceeded, indicates a process is outside of its normal operating range. A response to such an excursion should involve a documented investigation and corrective actions based on the results of that investigation. (TR13) An established microbial or non-viable particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. (TR22) An established microbial or airborne particle level for environmental, water or gas monitoring that, when exceeded, indicates that a facility process is outside of its normal operating range. The response to such an excursion involves a documented investigation and corrective actions based on the results of that investigation. The prescribed action level is often specified in guidance or standards relating to environmental monitoring and water quality. (TR69) An established microbial or nonviable particle level for environmental, water, or gas monitoring that, when exceeded, indicates a facility or process is outside of its normal operating range. The response to such an excursion may involve a documented investigation and corrective actions based on the results. The prescribed action level is often specified in guidances or standards relating to environmental monitoring and water quality (3-6). (TR88)

Source:

Action Level (environmental monitoring)

An established microbial or non-viable particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. (TR22)

Source:

Action Limit

An internal (in-house) value used to assess the consistency of the process. The cause of the excursion should be investigated and documented and corrective action is generally required. Action limits are not specifications. (TR42) An established internal (in-house) data-based value which is part of the control strategy and used to assess the consistency of the manufacturing process. An action limit excursion result in an investigation, identification of recovered isolates, root-cause analysis, assessment of a systemic failure and impact on product quality and patient safety. (TR69) An established internal (in-house) data-based value that is part of the control strategy and used to assess the consistency of the manufacturing process. An action limit excursion result in an investigation, identification of recovered isolates, root-cause analysis, assessment of a systemic failure and impact on product quality and patient safety. (TR74) A limit that, when exceeded, indicates a process is outside of its normal operating range. A response to such an excursion should involve a documented investigation and corrective actions based on the results of that investigation. (TR60)

Source:

Advanced Aseptic Process

A process in which direct intervention with open product containers or exposed product contact surfaces by operators wearing conventional cleanroom garments is not required and never permitted. (TR77)

Source:

Adventitious Agents

A foreign material that is introduced inadvertently; not natural or hereditary (as in microbial, chemical, or biochemical contamination of a purified substance). (TR 69)

Source:

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:

Aerobic Microorganism

A microorganism that utilizes oxygen as the final electron acceptor during metabolism; a microorganism that will grow primarily in the presence of oxygen. For the purpose of this report, this definition encompasses facultative anaerobes. (TR22) (TR62)

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:

Alert Level

An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action but typically requires follow-up investigation. (TR13) (TR22) (TR69) An established level that, when exceeded, is giving an early warning of a potential drift from normal operating conditions; while not necessarily grounds for definitive corrective action, it typically requires follow-up review. (TR 60) An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action, but typically requires follow-up investigation (3, 4, 7). (TR88)

Source:

Alert Limit

An established internal (in-house) data-based value giving early warning of potential drift of manufacturing process from normal operating conditions and triggers appropriate follow-up investigations. Alert limits are always lower than action limits. (TR69)

Source:

Alternative or Rapid Microbiological Method (RMM)

A novel, modern and/or fast microbiological testing method that is different from a classical or traditional growth-based method, such as agar-plate counting or recovery in liquid broth media. The alternative or rapid method may utilize instrumentation and software to manage the testing and resulting data, and may provide quantitative, qualitative and/or microbial identification test results. Automated technologies that utilize classical growth-based methods may also be designated as being novel, modern or rapid, based on their scientific principle and approach to microbial detection. The terms alternative, rapid microbiological method, rapid method and the acronym RMM are used interchangeably within this technical report. (TR33)

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:

Antimicrobial Chemical Agent

Substance used to destroy or suppress the growth of microorganisms, whether bacteria, fungi, or viruses, on inanimate objects and surfaces. (TR70)

Source:

Area Disinfection

Disinfection of floors, walls, ceilings, and other surfaces. (TR70)

Source:

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)

Source:

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)

Source:

Aseptic Processing Simulation (APS)

A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)

Source:

Bacterial Endotoxin Test (BET)

Assay for measuring active endotoxin by combining a liquid test sample with Limulus amebocyte lysate (LAL) reagent and measuring the resulting proportional reaction via visual, turbidimetric, chromogenic, or other validated means of detection. (TR3)

Source:

Ballotini

Small glass beads (spheres) obtainable in a range of sizes, used in the recovery of spores from paper carriers. (TR51)

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 Medicinal Product

A product (therapeutic or prophylactic) for human use that has been manufactured in or from a biological source. Examples include recombinant therapeutic proteins or vaccines. Biological medicinal products are also referred to as: biological medicines, biological products, biologics and biologic drugs. (TR 71)

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:

Biologics License Application (BLA)

An application, filed with the US Food and Drug Administration (FDA), which contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical effects of the biologic product (similar function as the Marketing Authorization Application in Europe). (TR56)

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:

CE Marking

The CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. (TR58)

Source:

Characterization Method

Scientifically sound method of a generally complex nature that is used for nonroutine assessment of specific biochemical, chemical, physicochemical, immunochemical, microbiological, and biological characteristics or inherent properties of a compound. (TR 57-2)

Source:

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)

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:

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:

Detergent

A synthetic wetting agent and emulsifier that can be added to a solvent to improve its cleaning efficiency. (TR70)

Source:

Downstream Side (of Filter)

The effluent side of the process step (filter). (TR45) The filtrate or outlet side of the filter. (TR26)

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:

Endospore

A type of spore formed intracellularly by some bacterial genera. (TR51)

Source:

Endotoxin

Lipopolysaccharides from the cell walls of bacteria, the most potent of which derive from Gram-negative organisms. When injected, they are known to cause a febrile, or fever-producing reaction that can cause severe patient reactions, and on occasion, can be fatal. (TR26) (TR44) Pyrogenic lipopolysaccharide component of Gram-negative bacterial cell walls. (TR69)

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:

Displaying results 1 - 50 of 103