
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 49: Validation: Cleaning Biotech (8)
- TR 54-3: QRM: Drug Products (2)
- TR 63: Clinical Trials Material Preparation (2)
- TR 70: Cleaning/Disinfection Programs (2)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 60: Process Validation (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 41: Virus Filtration (1)
- TR 42: Validation: Protein Manufacturing (1)
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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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Active Pharmaceutical Ingredient (API)
Synonym: Drug Substance. (TR14) (TR42) A substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. (TR54-4) Any substance or mixture of substance intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Note: also known as Drug Substance. (TR29) (TR56) (TR41) (TR54-3) (TR60) Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity o other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body. (TR63) (TR70) Any substance or mixture of substances intended to be used in the manufacture of a drug product, and that when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body. (TR74)
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Active Pharmaceutical Ingredient (API) or (Drug substance)
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and when used in the production of a drug, becomes an active ingredient of the drug product (also called “drug substance”). (TR29) Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. (TR54-3) Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body. (TR63)
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Clean
Having product residues, process residues, and environmental contaminants removed to an acceptable level. (TR29) (TR49) The implementation of procedures to render an area, piece of equipment, system, or object free of adulterants and contaminants. (TR 70)
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Cleaning Validation
Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)
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Cleaning Verification
A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)
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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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Dedicated Equipment
Equipment used exclusively for the manufacture of only one drug product, bulk drug substance, or intermediate. (TR29)
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Dirty Hold Time
The time from the end of product manufacturing until the beginning of the cleaning process (also called “soiled hold time”). (TR29)
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Free Drained Equipment
No visible water pool in the equipment or line when viewed under appropriate lighting conditions (but may contain water droplets). (TR29)
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Grouping Strategy
A strategy for establishing similar cleaning processes, usually based on similar products or similar equipment, and to validate the cleaning process based primarily on validation data for a representative of the group. (TR29) (TR49)
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Highly Hazardous Drug Active
A drug active that can cause serious adverse effects at typical doses. Those adverse effects are generally not related to the main therapeutic activity of the drug, and includes effects such as carcinogenicity, mutagenicity, genotoxicity, reproductive hazards, allergenicity, and cytotoxicity. (TR29)
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Limit
A value for a residue above which a cleaning process would not be acceptable. (TR29) A value for a residue above which a cleaning validation protocol would fail. (TR49)
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Mock Soil
A soil which is used in place of the manufactured product during a cleaning validation protocol (also called a “surrogate” soil). (TR29)
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Mock Soiling
A process of soiling the equipment for a cleaning validation protocol in which soil is applied to the equipment surfaces to simulate the condition of the soil on those surfaces following typical product manufacturing. (TR29)
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Normal Dose
The therapeutic dose of a product as given on the approved product labeling. (TR29) (TR49)
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Product Changeover
Procedural steps taken for switching from the manufacturing of one product to another product. (TR29)
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Recovery Study
A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR29) A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR49)
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Soil
The chemical or microbiological materials left on process equipment after completion of process manufacturing, but before initiation of the cleaning process. (TR29)
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Worst Case Soil
A soil that is the most difficult to clean from production equipment based on knowledge generated from laboratory studies, scientific properties, and/or production experience. (TR29)
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Worst-Case Process Condition
A condition or set of conditions encompassing upper and/or lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions (such conditions do not necessarily induce product or process failure). (TR29)