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 22: Aseptic Process Simulation (7)
- TR 60: Process Validation (5)
- TR 62: Manual Aseptic Processes (5)
- TR 69: Bioburden/Biofilm Management (5)
- TR 13: Environmental Monitoring (2)
- TR 28: Process Simulation for Bulk API (2)
- TR 50: Alt. Methods Mycoplasma Testing (1)
- TR 51: Biological Indicators (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 33: Rapid Micro Methods (1)
- TR 42: Validation: Protein Manufacturing (1)
- TR 43: Glass Defects (1)
- TR 45: Depth Filtration (1)
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
Source: TR 22: Aseptic Process Simulation
Manufacturing Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Quality Risk Management/QRM
Source: TR 60: Process Validation
Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM
Source: TR 43: Glass Defects
Manufacturing Packaging Science Quality Risk Management/QRM Supply Chain Visual Inspection
Source: TR 69: Bioburden/Biofilm Management
Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing
Source: TR 22: Aseptic Process Simulation
Biotechnology Manufacturing Combination Products Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Validation Sterile Processing
Source: TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC)
Manufacturing GMP/Good Manufacturing Processes/cGMP Packaging Science Quality Risk Management/QRM
Source: TR 60: Process Validation
Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM
Source: TR 69: Bioburden/Biofilm Management
Manufacturing Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing
Source: TR 22: Aseptic Process Simulation
Biotechnology Manufacturing Combination Products Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Validation Quality Risk Management/QRM Sterile Processing
Source: TR 60: Process Validation
Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM
Source: TR 45: Depth Filtration
Biotechnology Manufacturing Filtration Packaging Science Sterile Processing Supply Chain
Source: TR 13: Environmental Monitoring
Biotechnology Manufacturing Combination Products Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Validation Sterile Processing
Source: TR 51: Biological Indicators
Biotechnology Manufacturing Microbiology Packaging Science Validation Quality Risk Management/QRM Sterile Processing
Source: TR 50: Alt. Methods Mycoplasma Testing
Biotechnology Manufacturing Microbiology Packaging Science Validation Quality Risk Management/QRM Sterile Processing
Source: TR 33: Rapid Micro Methods
Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing
Source: TR 13: Environmental Monitoring
Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing
Source: TR 22: Aseptic Process Simulation
Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing
Source: TR 22: Aseptic Process Simulation
Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science
Source: TR 42: Validation: Protein Manufacturing
Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing
Source: TR 22: Aseptic Process Simulation
Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing