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 (2)
- TR 54: QRM:Manufacturing Operations (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 60: Process Validation (1)
- TR 67: Objectionable Microorganisms (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (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 44: QRM: Aseptic Processes (1)
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Drug Product (DP)
A pharmaceutical product type that contains a drug substance, generally, in association with excipients. [Synonym: Dosage Form; Finished Product] (TR57)(TR14)(TR42)
A finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.(TR38) (TR67) (TR88)
The dosage form in the final immediate packaging intended for marketing.(TR60)(TR82)
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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)