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.
(Please select "All" to restart a filtered Search)
Refine Results
Filter By Technical Report Number
- TR 54-2: QRM: Packaging Labeling (1)
- TR 54-3: QRM: Drug Products (1)
- TR 57: Analytical Method Validation (1)
- TR 64: Temp Controlled Systems Qualification (1)
- TR 67: Objectionable Microorganisms (1)
- TR 68: Drug Shortage Management (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 39: Cold Chain (1)
- TR 43: Glass Defects (1)
Filter By Technical Report Keyword
Filter By Technical Report Category
Qualification
Documented testing that demonstrates with a high degree of assurance that a specific process will meet its pre-determined acceptance criteria. (TR39) (TR58) (TR64)
Source:
Quality Risk Management (QRM)
A systematic process for the assessment, control, communication, and review of risk to the quality of the drug product across the product lifecycle.(TR43)(TR54-2)(TR54-3)(TR57)(TR67)(TR68)
Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).(TR58)
A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.(TR 54-5)(TR 76)(TR88)