USP's New Requirements for Compendial Validation

Recommendation

22/23 October 2019
Vienna, Austria

Handling OOE and OOT Results

An interesting article from the USP on the future requirements for compendial validation has been published in the Pharmacopoeial Forum 39(6).
This is the first General Chapter in a series of chapters which should introduce significant changes in the approaches to validation and its influences on compendial procedures.

This new chapter <1200> will concentrate on the types of data expected by the USP to see if an analytical method can be accepted before it is included in USP/NF. Methods containing the data expected in the future will be suitable for compendial applications.

According to USP's "General Notices" 6.30, alternative procedures may be used as long as they have been validated or have been demonstrated to be equivalent to or better than the existing compendial procedure.

The article lists the different parameters for compendial validation. Concrete propositions are made. Five standardised studies may be used to evaluate the acceptability of a new procedure:

• Specificity
• Accuracy
• Precision
• Range
• Detectability

The USP wishes to get feedback to the propositions made in this article.

You can find all information on the USP website of the Pharmacopeial Forum (PF).