New USP Chapter on Method Transfer effective

Recommendation

19-21 May 2021

Live Online Training: EU GMP-/FDA-compliant Sampling

In the Pharmacopeoial Forum (PF) from September/October 2009, a proposal for a General Chapter on method transfer was mentioned for the first time. Some time ago, a draft for a General Chapter <1224> was published in the PF. This chapter entitled "Transfer of Analytical Methods has now come into effet in the USP 35.

The method transfer is a documented process which establishes the evidence that a laboratory is qualified to use an analytical method which has been elaborated in another laboratory. Hereby the evidence must be brought that the laboratory has the knowledge and the ability to perform the analytical method as intended. The USP Chapter describes:

• the different types of transfers
• the required comparison tests
• Co-validation between two or more laboratories
• Re-validation as an alternatiive approach
• "Transfer Waiver" including justification where no method transfer is required
• Elements required for a successful method transfer
• The pre-approved transfer protocol
• The analytical method
• The transfer report 

All these indications can be found in the General Chapter <1224> of USP 35.

Learn more about the new Chapter during the ECA Conference "Compliance Update: EP, USP, and JP - Update on New Monographs - Dealing with Divergent Compendial Methods", taking place from 21 - 22 June 2012 at the Corinthia Hotel in Prag, Czech Republic. Dr Chris Burgess, Member of the respective USP expert group who has elaborated the new chapter will present it.

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)