GMP News - APIs and Excipients

The European Directorate for the Quality of Medicines & HealthCare (EDQM) issued a press release indicating that public consultation on two Ph. Eur. chapters on pharmaceutical technology procedures has been started. These are the revised general chapter 2.9.3 "Dissolution of tablets and capsules" and the new general chapter 2.9.55 "Characterisation of powder behaviour during compression".

The U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.

In the EudraGMDP database, results of European inspectors are published in so-called Non-Compliance Reports. In the period October-November 2022, there were two reports in the area of GMP, both of which were issued due to cross contamination.

The EDQM (European Directorate for the Quality of Medicines & HealthCare) has adopted the document "Management of CEP guidelines and operational documents for the CEP procedure" by the end of 2022 and has now published it on its website. This document explains the new process for the development of supporting documentation related to CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia).

The two pharmacopoeial monographs (2034) and (2619) have recently been revised. Read more about the requirements that manufacturers of APIs need to follow with regard to possible nitrosamine contamination in their products.

The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.