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 (6)
- TR 26: Sterilizing Filtration of Liquids (5)
- TR 50: Alt. Methods Mycoplasma Testing (4)
- TR 1: Validation: Moist Heat (4)
- TR 51: Biological Indicators (3)
- TR 56: Phase Appropriate cGMP Application (3)
- TR 67: Objectionable Microorganisms (3)
- TR 80: Data Integrity Management System for Pharmaceutical Laboratories (3)
- TR 57-2: Analytical Method Development (2)
- TR 68: Drug Shortage Management (2)
- TR 82: Low Endotoxin Recovery (2)
- TR 29: Validation: Cleaning (2)
- TR 45: Depth Filtration (2)
- TR 46: Good Distribution: Last Mile (1)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 55: TBA/TCA Detection Mitigation (1)
- TR 58: Temp Controlled Distribution (1)
- TR 61: Steam in Place (1)
- TR 63: Clinical Trials Material Preparation (1)
- TR 65: Technology Transfer (1)
- TR 66: Single-Use Systems (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 3: Validation: Dry Heat (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 22: Aseptic Process Simulation (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 28: Process Simulation for Bulk API (1)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (1)
- TR 30: Parametric Release (1)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 41: Virus Filtration (1)
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- GMP/Good Manufacturing Processes/cGMP (39)
- Microbiology (31)
- Validation (24)
- Sterile Processing (22)
- Biotechnology (21)
- Quality Risk Management/QRM (16)
- Technology Transfer (16)
- Filtration (8)
- Supply Chain (7)
- Virus (6)
- Outsourcing (4)
- Packaging Science (4)
- Inspections (3)
- Combination Products (1)
- Prefilled Syringes/PFS (1)
- Visual Inspection (1)
Monodispersed particles
Particles of uniform size in a dispersed phase. In the case of viruses, this term refers to free virus particles not agglomerated to other viruses or proteins in solution. (TR41)
Source:
Most Probable Number (MPN) Method
A statistical method of estimating the number of viable organisms suspended in a liquid. (TR51)
Source:
Multi-Use System (MUS)
An engineered process equipment solution for process management and unit operations designed for repeated use. (TR66)