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 14: Validation: Protein Purification Chromatography (4)
- TR 47: Virus Spikes/Virus Clearance (3)
- TR 70: Cleaning/Disinfection Programs (3)
- TR 75: Mycoplasma Filter Rating Method (3)
- TR 50: Alt. Methods Mycoplasma Testing (2)
- TR 57: Analytical Method Validation (2)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (2)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (2)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 49: Validation: Cleaning Biotech (1)
- TR 51: Biological Indicators (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 57-2: Analytical Method Development (1)
- TR 58: Temp Controlled Distribution (1)
- TR 60: Process Validation (1)
- TR 61: Steam in Place (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 71: Emerging Methods for Virus Detection (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 22: Aseptic Process Simulation (1)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 29: Validation: Cleaning (1)
- TR 42: Validation: Protein Manufacturing (1)
Filter By Technical Report Keyword
- Biotechnology (19)
- Manufacturing (17)
- GMP/Good Manufacturing Processes/cGMP (17)
- Quality Risk Management/QRM (13)
- Sterile Processing (13)
- Validation (12)
- Filtration (5)
- Packaging Science (4)
- Technology Transfer (4)
- Virus (3)
- Vaccines (3)
- Combination Products (2)
- Prefilled Syringes/PFS (2)
- Inspections (1)
- Supply Chain (1)
- Visual Inspection (1)
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)
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CFU: Genome Copy Ratio
The relationship between the number of colony forming units counted on solid media and the number of genome copies measured using a method suitable for quantitative assessment of genomic DNA. (TR50)
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Carrier
A solid support upon which the test organism used in biological monitoring is inoculated. (TR51)
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Cell Substrate
The host cells that are used to propagate or detect viruses. (TR 47)
Cells used for the manufacture of a biological medicinal product. (TR 71) (TR 83)
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Challenge Concentration
The concentration in Colony Forming Units/mL of the test microorganism in the challenge fluid. (TR75)
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Challenge Level
The concentration of the test microorganism applied to the test filter (per centimeter squared) or the total number of cells applied to the test filter at the completion of the challenge. (TR75)
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Challenge Volume
The volume of challenge fluid applied to the test filter. (TR75)
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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)
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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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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)
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Color Changing Unit (CCU)
The quantity of mycoplasma contained in the highest dilution of a test article that produces a color change in a pH-sensitive liquid medium (typically containing phenol red) within a specified time of incubation, used for end-point determination of growth. (TR50)
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Column Load
The solute that is passed through the column for separation. (TR14)
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Column Packing
Preparation of a column that includes the addition of resin slurry into a column to create a bed suitable for its intended use. Characteristics of a packed column bed include bed height and diameter, backpressure, and number of theoretical plates. (TR14)
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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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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)
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Contaminants (Contamination)
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 (16). The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API [drug substance] during production [manufacture], sampling, packaging or repackaging, storage or transport (17).
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Contamination Rate
The percentage of units filled in a process simulation that are positive for microbial growth after incubation. (TR22)
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Correlation Coefficient ( r )
A measure of covariation, the square root of the coefficient of determination. (TR57)
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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)
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Coverage
The appropriate distribution of a chemical agent needed on the equipment surface to be effective. (TR70)
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Critical Aspect Design Elements (CADE)
Critical aspect design elements are components, instruments, and process controls that comprise the critical aspect (e.g., temperature feedback loop). Critical aspect design elements are tested in commissioning and qualification. (TR54-5)
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Critical Aspects (CAs) of Manufacturing Systems
Critical aspects are constituent parts of a system or piece of equipment that provide the ability to control one or more critical process parameter of the associated process (e.g., temperature controller of a bioreactor). (TR54-5)
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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.
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Cross-Functional Team
An investigatory team, comprising representatives including QCU microbiologists, manufacturing, engineering, and maintenance personnel, and other appropriate SMEs, with the purpose of conducting a manufacturing investigation. (TR88)
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Cycle Development
A series of activities performed for the purpose of defining or confirming the cycle parameters (e.g., time, temperature, pressure) necessary to ensure sanitization or sterilization. (TR61)
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Cycle Phases
A discrete series of sterilizer process steps (such as, heat-up, exposure and cool-down) performed sequentially that represent a complete sterilization cycle. (TR48)
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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)
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Cytopathic Virus
Viruses where infection of cells results in microscopically visible degeneration of the cells or other morphological changes. (TR47)