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 42: Validation: Protein Manufacturing (3)
- TR 56: Phase Appropriate cGMP Application (2)
- TR 57: Analytical Method Validation (2)
- TR 61: Steam in Place (2)
- TR 74: Reprocessing of Biopharmaceuticals (2)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (2)
- TR 54: QRM:Manufacturing Operations (1)
- TR 60: Process Validation (1)
- TR 64: Temp Controlled Systems Qualification (1)
- TR 67: Objectionable Microorganisms (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 3: Validation: Dry Heat (1)
- TR 13: Environmental Monitoring (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 43: Glass Defects (1)
- TR 44: QRM: Aseptic Processes (1)
- TR 45: Depth Filtration (1)
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Drug Substance (DS)
The active ingredient that is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients, including buffers and other components. [Synonyms: bulk drug substance, bulk material, active pharmaceutical ingredient (API)] (TR14) (TR57) (TR74) (TR60)
Active pharmaceutical ingredient in a drug product that is responsible for that product’s therapeutic activity.(TR67) (TR82) (TR88)
See Active Pharmaceutical Ingredient (API). (TR56)
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Operational Qualification (OQ)
Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR14) (TR61) (TR64) (TR72)
The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR54-5)
Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges (17). (TR60-3)
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Process Validation
The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API (drug substance) meeting its predetermined specifications and quality attributes. (TR14) (TR42)
Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. (TR44)
The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products. (TR54) (TR57) (TR74)
The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.
The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes, as described in EMA, EU GMP, Part 1, Annex 15, drug/medicinal product. (TR56)
EMA: The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
US FDA: The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products. (TR60-2)
The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or drug substance meeting its predetermined specifications and quality attributes (1, 17). (TR60-3)
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Retrospective Process Validation
Validation of an existing manufacturing process that occurs by reviewing data from relevant historical and test production records. (TR14) (TR42)
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Revalidation
Repeating partial or full validation of a process after a process change is implemented. Re-validation is change-based, not time-based. (TR14) (TR3) (TR42)
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Sanitization
Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13) A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14) The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45) A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)
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Scale-Down Model
A small-scale process step that has been demonstrated to be representative of a production-scale operation. (TR14)