Understanding the New USP Chapter <1224> for Transfer of Analytical Methods
Why Should You Attend:
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. So far there has not been an official guidance on what exactly is expected to maintain ‘the validated state’. Now the USP has published the final version of the general chapter <1224>.
Also the FDA has released an official guidance on how to conduct and document method transfer and FDA is starting to enforce the new USP chapter. Now it is a good time to learn how to conduct and document method transfer.
This session will equip participants with a comprehensive understanding of USP and FDA requirements for transfer of analytical methods and provide recommendations and tools for effective implementation.
Free Hand-outs:
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 this webinar:
- FDA and International expectations for method transfer.
- Examples of FDA warning letters and how to avoid them.
- The FDA Guidance on method transfer.
- The new 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.
