Revision of the USP General Chapter <1058> – a credibility issue!

Whenever one would like to evaluate a pharmaceutical product such as tablet/capsule, a commonly accepted approach is to seek a test described in the USP. The reason being that the tests described in the USP are being promoted and considered as references for products testing. The USP often provides seminars and hands-on training describing these tests (e.g. drug dissolution) and their validations. The regulatory authorities world-wide enforce the standards described in the USP monographs (see e.g. US FDA dissolution methods database, https://tinyurl.com/y78ovyez) considering that the methods and associated instruments described in the USP are adequately and independently qualified and validated.

With the revision of the USP General Chapter <1058>, however, this situation appears to have changed (https://tinyurl.com/y9wdfl58). In the revised Chapter it is described that the users are responsible for the qualification, and by extension validation of the instruments. This may not be a true representation of the practice. If this would have been the case then instruments would have to come with the users’ reference as to who performed the qualification (as well as how), and on what basis the instruments have been included in the USP. In reality, vendors and users promote manufacturing and the use of these instruments, respectively, by making claims that instruments manufactured or used are as per “USP specifications”, not those of their own qualification or validation standards. Obviously, this revision of the USP chapter is unusual and in error and might impact negatively on USP’s credibility as a standard setting organization for quality assessment of pharmaceutical products.

If the issue is with a certain specific type of instruments such as drug dissolution, which are known to be non-qualified and non-validated, then a more appropriate approach would be to remove such instruments from the USP rather than creating doubts about the qualification/validation of all instruments and associated methods described in the USP.

It is my view that the revision of the Chapter is not in line with the USP objectives and practices, and the decision may have been taken in haste, therefore, requiring reconsideration.

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