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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Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Prefilled Syringes/PFS Validation Quality Risk Management/QRM Sterile Processing Supply Chain Technology Transfer Vaccines Visual Inspection
Source: TR 45: Depth Filtration
Manufacturing Filtration Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer
Source: TR 29: Validation: Cleaning
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing Technology Transfer
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing Technology Transfer
Source: TR 33: Rapid Micro Methods
Biotechnology Manufacturing Microbiology Validation Sterile Processing Technology Transfer
Source: TR 33: Rapid Micro Methods
Biotechnology Manufacturing Microbiology Validation Sterile Processing Technology Transfer
Source: TR 61: Steam in Place
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer
Source: TR 48: Moist Heat Sterilizer Systems
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer