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 (7)
- TR 57-2: Analytical Method Development (3)
- TR 56: Phase Appropriate cGMP Application (2)
- TR 1: Validation: Moist Heat (2)
- TR 80: Data Integrity Management System for Pharmaceutical Laboratories (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 51: Biological Indicators (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 61: Steam in Place (1)
- TR 63: Clinical Trials Material Preparation (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
Source: TR 80: Data Integrity Management System for Pharmaceutical Laboratories
Manufacturing GMP/Good Manufacturing Processes/cGMP Quality Risk Management/QRM Technology Transfer
Source: TR 80: Data Integrity Management System for Pharmaceutical Laboratories
Manufacturing GMP/Good Manufacturing Processes/cGMP Quality Risk Management/QRM Technology Transfer
Source: TR 57: Analytical Method Validation
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Technology Transfer
Source: TR 57: Analytical Method Validation
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation 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 56: Phase Appropriate cGMP Application
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Technology Transfer
Source: TR 57: Analytical Method Validation
GMP/Good Manufacturing Processes/cGMP Validation Technology Transfer
Source:
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Technology Transfer
Source: TR 57-2: Analytical Method Development
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Technology Transfer
Source: TR 26: Sterilizing Filtration of Liquids
Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Technology Transfer
Source: TR 57: Analytical Method Validation
GMP/Good Manufacturing Processes/cGMP Validation Technology Transfer
Source: TR 63: Clinical Trials Material Preparation
Manufacturing GMP/Good Manufacturing Processes/cGMP Outsourcing Packaging Science Supply Chain Technology Transfer
Source: TR 57: Analytical Method Validation
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Technology Transfer
Source: TR 51: Biological Indicators
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Supply Chain Technology Transfer
Source: TR 47: Virus Spikes/Virus Clearance
Virus Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Technology Transfer
Source: TR 56: Phase Appropriate cGMP Application
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Technology Transfer
Source: TR 54-4: QRM: Biotech Drug Substance
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Technology Transfer