Extractables & Leachables
Module Lenght
1 day
Agenda
- Extractables and Leachables
- General Concepts
- Importance of a good Extractables & Leachables qualification
- International Regulatory Context
- Requirements (EMEA, FDA and ICH)
- Extractables and Leachables Strategy Approach
- Conditions selection
- Analytical Techniques and Methodologies
- Leachable Study Design
- Risk Assessment on Extractables and Leachables
- Safety Evaluation
- Toxicological Assessment
- EMA guideline on Genotoxic Impurities
- PQRI Threshold
- Practical Case Studies on
- Pre-filled Syringes
- Lyophilized Drug Products
- Injectables
- Large Volume Parenterals
- Disposable and Single-Use Systems
- Single Use Equipment Process Validation Requirements
Target audience
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Technology Transfer
- Validation
- R&D
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
-
Regulatory & technical references
- ICH Q7
- FDA 21 CFR
- USP <87>,<88>,<660>,<661>,<1660>, <1663>,<1664>
- Eu cGMP Vol 4
- PDA TR 26 “Sterilizing Filtration of Liquids”
- PDA TR 66 ” Application of Single-Use Systems in Pharmaceutical Manufacturing”
Number of trainers
One/Two
Tailoring option available
Yes
Final evaluation quiz
Yes