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 57: Analytical Method Validation (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (1)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (1)
- TR 42: Validation: Protein Manufacturing (1)
- TR 44: QRM: Aseptic Processes (1)
Source: TR 14: Validation: Protein Purification Chromatography
Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Technology Transfer