When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain ‘the validated state’. Now the USP has published an updated general chapter . Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2015 on validation of analytical methods. This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.
For easy implementation, attendees will receive:
- SOP: Transfer of Analytical Methods
- Checklist: Transfer of Analytical Methods and Procedures
- Master Plan template and examples: Transfer of Analytical Methods and procedures
Areas Covered in the Session :
- FDA and International expectations for method transfer
- Examples of FDA warning letters and how to avoid them
- The FDA Guidance on method transfer.
- The USP chapter <1224>: history, status, future
- Four approaches for analytical method transfer and testing
- Responsibilities of the transferring and receiving laboratory
- Developing a transfer plan and a pre-approval protocol
- Conducting comparative studies
- Criteria and approaches for risk based testing: what, when, how much?
- The importance and selection of acceptance criteria
- Dealing with technology transfer: validation requirements, regulatory notification.
- Method transfer from standard HPLC to UHPLC
- Most likely failures during method transfer
- Handling deviations from documented acceptance criteria
- Criteria for transfer waiver (omission of formal transfer)
- Method transfer protocol and summary report
Who Will Benefit:
- Lab Supervisors and Managers
- QA Managers and Personnel
- Research & Development in Pharmaceutical Industry
- Pharmaceutical Quality Control
- Contract Laboratories