Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation

Overview:

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'. In the meantime the USP has published an updated general chapter <1224>.

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 guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria.

This seminar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.

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
• The new EU GMP chapter 6 on method transfer
• Four approaches for analytical method transfer and testing
• Responsibilities of the transferring and receiving laboratory
• Developing a transfer plan and a pre-approval protocol
• Examples for conducting comparative studies
• Criteria and approaches for risk based testing: what, when, how much?
• The importance and selection of acceptance criteria
• 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

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

Who Will Benefit:

• Analysts
• Lab Supervisors and Managers
• QA managers and personnel
• Analysts
• Consultants
• Teachers