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 55: TBA/TCA Detection Mitigation (19)
- TR 58: Temp Controlled Distribution (13)
- TR 39: Cold Chain (13)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (11)
- TR 46: Good Distribution: Last Mile (8)
- TR 22: Aseptic Process Simulation (8)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (8)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (8)
- TR 43: Glass Defects (8)
- TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (7)
- TR 45: Depth Filtration (7)
- TR 62: Manual Aseptic Processes (6)
- TR 64: Temp Controlled Systems Qualification (6)
- TR 66: Single-Use Systems (6)
- TR 60: Process Validation (5)
- TR 69: Bioburden/Biofilm Management (5)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (5)
- TR 48: Moist Heat Sterilizer Systems (4)
- TR 51: Biological Indicators (4)
- TR 63: Clinical Trials Material Preparation (4)
- TR 67: Objectionable Microorganisms (4)
- TR 70: Cleaning/Disinfection Programs (4)
- TR 1: Validation: Moist Heat (4)
- TR 14: Validation: Protein Purification Chromatography (4)
- TR 26: Sterilizing Filtration of Liquids (4)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (4)
- TR 49: Validation: Cleaning Biotech (3)
- TR 50: Alt. Methods Mycoplasma Testing (3)
- TR 52: Supply Chain GDP (3)
- TR 54-4: QRM: Biotech Drug Substance (3)
- TR 57: Analytical Method Validation (3)
- TR 68: Drug Shortage Management (3)
- TR 15: Validation: TFF in Biopharmaceuticals (3)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (3)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (3)
- TR 28: Process Simulation for Bulk API (3)
- TR 29: Validation: Cleaning (3)
- TR 41: Virus Filtration (3)
- TR 54: QRM:Manufacturing Operations (2)
- TR 13: Environmental Monitoring (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- TR 42: Validation: Protein Manufacturing (2)
- TR 54-2: QRM: Packaging Labeling (1)
- TR 57-2: Analytical Method Development (1)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 3: Validation: Dry Heat (1)
- TR 80: Data Integrity Management System for Pharmaceutical Laboratories (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 33: Rapid Micro Methods (1)
- Manufacturing (115)
- Quality Risk Management/QRM (74)
- Supply Chain (74)
- GMP/Good Manufacturing Processes/cGMP (73)
- Biotechnology (58)
- Validation (52)
- Microbiology (26)
- Sterile Processing (23)
- Combination Products (22)
- Filtration (21)
- Inspections (21)
- Outsourcing (19)
- Prefilled Syringes/PFS (14)
- Visual Inspection (11)
- Technology Transfer (10)
- Lyophilization (4)
- Vaccines (2)
- Virus (1)
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