Glossary Search
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 (64)
- TR 1: Validation: Moist Heat (53)
- TR 26: Sterilizing Filtration of Liquids (53)
- TR 45: Depth Filtration (52)
- TR 41: Virus Filtration (43)
- TR 70: Cleaning/Disinfection Programs (41)
- TR 60: Process Validation (40)
- TR 14: Validation: Protein Purification Chromatography (40)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (40)
- TR 48: Moist Heat Sterilizer Systems (39)
- TR 58: Temp Controlled Distribution (39)
- TR 3: Validation: Dry Heat (38)
- TR 55: TBA/TCA Detection Mitigation (35)
- TR 15: Validation: TFF in Biopharmaceuticals (35)
- TR 56: Phase Appropriate cGMP Application (34)
- TR 50: Alt. Methods Mycoplasma Testing (32)
- TR 54: QRM:Manufacturing Operations (32)
- TR 80: Data Integrity Management System for Pharmaceutical Laboratories (31)
- TR 61: Steam in Place (29)
- TR 51: Biological Indicators (28)
- TR 47: Virus Spikes/Virus Clearance (27)
- TR 54-2: QRM: Packaging Labeling (27)
- TR 29: Validation: Cleaning (26)
- TR 57-2: Analytical Method Development (25)
- TR 67: Objectionable Microorganisms (25)
- TR 69: Bioburden/Biofilm Management (25)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (25)
- TR 44: QRM: Aseptic Processes (25)
- TR 64: Temp Controlled Systems Qualification (24)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (24)
- TR 13: Environmental Monitoring (24)
- TR 22: Aseptic Process Simulation (24)
- TR 62: Manual Aseptic Processes (22)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (22)
- TR 39: Cold Chain (22)
- TR 54-4: QRM: Biotech Drug Substance (18)
- TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (18)
- TR 30: Parametric Release (18)
- TR 42: Validation: Protein Manufacturing (18)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (17)
- TR 43: Glass Defects (17)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (16)
- TR 33: Rapid Micro Methods (16)
- TR 63: Clinical Trials Material Preparation (15)
- TR 68: Drug Shortage Management (15)
- TR 74: Reprocessing of Biopharmaceuticals (14)
- TR 66: Single-Use Systems (13)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (13)
- TR 49: Validation: Cleaning Biotech (12)
- TR 54-3: QRM: Drug Products (12)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (11)
- TR 28: Process Simulation for Bulk API (11)
- TR 46: Good Distribution: Last Mile (10)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (10)
- TR 82: Low Endotoxin Recovery (10)
- TR 71: Emerging Methods for Virus Detection (9)
- TR 75: Mycoplasma Filter Rating Method (9)
- TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (9)
- TR 52: Supply Chain GDP (8)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (8)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (7)
- TR 53: Stability Testing New Drug Products (6)
- TR 72: Passive Thermal Protection Systems: Qualification/Operations (6)
- TR 65: Technology Transfer (5)
- TR 81: Cell-Based Therapy Control Strategy (2)
- TR 78: Particulate Matter in Oral Dosage Forms (2)
- Manufacturing (786)
- GMP/Good Manufacturing Processes/cGMP (529)
- Validation (504)
- Quality Risk Management/QRM (468)
- Microbiology (323)
- Biotechnology (321)
- Sterile Processing (314)
- Technology Transfer (215)
- Packaging Science (166)
- Filtration (141)
- Supply Chain (119)
- Virus (80)
- Inspections (61)
- Combination Products (50)
- Prefilled Syringes/PFS (46)
- Outsourcing (45)
- Visual Inspection (26)
- Vaccines (12)
- Lyophilization (4)
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Combination Products GMP/Good Manufacturing Processes/cGMP Quality Risk Management/QRM
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source:
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Manufacturing GMP/Good Manufacturing Processes/cGMP Inspections
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source:
Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source: TR 60: Process Validation
GMP/Good Manufacturing Processes/cGMP Microbiology Validation
Source: TR 60: Process Validation
Source: TR 60: Process Validation
Source:
Source: TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg
Source: TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg
Source:
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
Source:
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
GMP/Good Manufacturing Processes/cGMP Microbiology Validation
Source:
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
Source:
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
Manufacturing GMP/Good Manufacturing Processes/cGMP Validation
Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers
Manufacturing GMP/Good Manufacturing Processes/cGMP Validation
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source:
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source: TR 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Source:
Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Source:
Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Source: