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 70: Cleaning/Disinfection Programs (25)
- TR 1: Validation: Moist Heat (21)
- TR 69: Bioburden/Biofilm Management (19)
- TR 3: Validation: Dry Heat (16)
- TR 13: Environmental Monitoring (16)
- TR 51: Biological Indicators (15)
- TR 50: Alt. Methods Mycoplasma Testing (14)
- TR 61: Steam in Place (14)
- TR 47: Virus Spikes/Virus Clearance (12)
- TR 22: Aseptic Process Simulation (12)
- TR 62: Manual Aseptic Processes (10)
- TR 29: Validation: Cleaning (10)
- TR 57: Analytical Method Validation (9)
- TR 45: Depth Filtration (9)
- TR 33: Rapid Micro Methods (8)
- TR 48: Moist Heat Sterilizer Systems (7)
- TR 67: Objectionable Microorganisms (7)
- TR 26: Sterilizing Filtration of Liquids (7)
- TR 41: Virus Filtration (7)
- TR 71: Emerging Methods for Virus Detection (6)
- TR 28: Process Simulation for Bulk API (5)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (4)
- TR 30: Parametric Release (4)
- TR 49: Validation: Cleaning Biotech (3)
- TR 57-2: Analytical Method Development (3)
- TR 14: Validation: Protein Purification Chromatography (3)
- TR 15: Validation: TFF in Biopharmaceuticals (3)
- TR 75: Mycoplasma Filter Rating Method (3)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (3)
- TR 55: TBA/TCA Detection Mitigation (2)
- TR 60: Process Validation (2)
- TR 74: Reprocessing of Biopharmaceuticals (2)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- TR 42: Validation: Protein Manufacturing (2)
- TR 43: Glass Defects (2)
- TR 52: Supply Chain GDP (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 56: Phase Appropriate cGMP Application (1)
- TR 58: Temp Controlled Distribution (1)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 82: Low Endotoxin Recovery (1)
- TR 44: QRM: Aseptic Processes (1)
- Manufacturing (162)
- GMP/Good Manufacturing Processes/cGMP (153)
- Validation (113)
- Biotechnology (103)
- Quality Risk Management/QRM (86)
- Virus (34)
- Filtration (25)
- Packaging Science (15)
- Combination Products (12)
- Technology Transfer (10)
- Vaccines (8)
- Inspections (4)
- Prefilled Syringes/PFS (3)
- Supply Chain (1)
- Visual Inspection (1)
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
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 78: Particulate Matter in Oral Dosage Forms
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Quality Risk Management/QRM Sterile Processing
Source: TR 78: Particulate Matter in Oral Dosage Forms
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Quality Risk Management/QRM Sterile Processing
Source: TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology
Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Prefilled Syringes/PFS Quality Risk Management/QRM Sterile Processing
Source: TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology
Biotechnology Manufacturing Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Prefilled Syringes/PFS Quality Risk Management/QRM Sterile Processing
Source: TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology
Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 54-4: QRM: Biotech Drug Substance
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing
Source: TR 45: Depth Filtration
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 3: Validation: Dry Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 62: Manual Aseptic Processes
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 70: Cleaning/Disinfection Programs
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 26: Sterilizing Filtration of Liquids
Manufacturing Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 50: Alt. Methods Mycoplasma Testing
Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 47: Virus Spikes/Virus Clearance
Virus Biotechnology Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 13: Environmental Monitoring
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 67: Objectionable Microorganisms
GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing
Source: TR 51: Biological Indicators
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 61: Steam in Place
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 70: Cleaning/Disinfection Programs
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 13: Environmental Monitoring
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 29: Validation: Cleaning
Source: TR 51: Biological Indicators
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 70: Cleaning/Disinfection Programs
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 13: Environmental Monitoring
GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 45: Depth Filtration
Manufacturing Filtration Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer
Source: TR 70: Cleaning/Disinfection Programs
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 13: Environmental Monitoring
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 3: Validation: Dry Heat
Virus Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing
Source: TR 29: Validation: Cleaning
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer
Source: TR 50: Alt. Methods Mycoplasma Testing
Virus Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 69: Bioburden/Biofilm Management
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing
Source: TR 41: Virus Filtration
Virus Biotechnology Manufacturing Microbiology Quality Risk Management/QRM Sterile Processing Technology Transfer
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 67: Objectionable Microorganisms
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing Vaccines
Source: TR 51: Biological Indicators
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing Vaccines
Source: TR 50: Alt. Methods Mycoplasma Testing
Virus Biotechnology Manufacturing Microbiology Validation Sterile Processing
Source: TR 47: Virus Spikes/Virus Clearance
Virus Biotechnology Manufacturing Microbiology Validation Sterile Processing
Source: TR 70: Cleaning/Disinfection Programs
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing
Source: TR 1: Validation: Moist Heat
Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing
Source: TR 26: Sterilizing Filtration of Liquids
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 28: Process Simulation for Bulk API
Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing
Source: TR 13: Environmental Monitoring
GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing