GMP News

The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.

Fluoropolymers have an extremely high chemical stability. However, this stability also means that once they enter the environment, they can remain there for a very long time and cause environmental damage. The EU plans to restrict or ban perfluorinated and polyfluorinated alkyl substances (PFAS), which include PTFE, for example, in the future. This would have serious consequences for plants in the pharmaceutical industry, for example, where PTFE is used as a material for seals.

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

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.

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.

In a 3.5 pages position paper, Notified Bodies have presented their views on hybrid audits of medical device and IVD manufacturers. What does it say?

Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging? This is one of three new questions answered by the European Medicines Agency (EMA) on its website. The other two questions relate to the activities of brokers with parties outside the EEA.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.

If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. We have prepared an overview of the GDP Non-Compliance Reports published in 2022 and the respective reasons for issuing these reports.

Already in 2018, the ICH had started working on a Guideline entitled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS - Q13". A draft was published in mid-2021. Now ICH has approved the final version.

The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.