GMP News - Quality Assurance

To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.

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 USP revised the general chapter <661.1> Plastic Materials of Construction. In particular the sections on Polycarbonate and PVC have been updated.

In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022. Significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs) are listed and a long list of Data Integrity remedation activies is required.

With ICH Q9 Quality Risk Management becoming effective, risk analyses have become the "magic word" in the GMP environment. But risk analyses do not always help. An example of this can be found in an FDA Warning Letter on the subject of cross-contamination.

In December 2022, the "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were again revised and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at the different stages of the centralised marketing authorisation application process.