
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 54: QRM:Manufacturing Operations (2)
- TR 54-2: QRM: Packaging Labeling (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 57: Analytical Method Validation (1)
- TR 58: Temp Controlled Distribution (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (1)
- TR 30: Parametric Release (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 42: Validation: Protein Manufacturing (1)
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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)
Source:
Quality System
Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. (TR30) (TR44)
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met. (TR54-5)
Source:
Residual Risk
Risk remaining after risk control measures have been taken. (TR44) (TR58)
Risk remaining after risk control measures have been implemented (derived from ISO 14971:2007). (TR54) (TR54-2)
Risk remaining after risk control measures has been implemented. (TR54-5)