GMP News - APIs and Excipients

In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.

As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.

In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.

The draft guideline "Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products - VICH GL 60" of the VICH can still be commented on until the end of March 2024. Comments can be submitted via the U.S. FDA website, for example.

In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.

We recently reported on a case in which the failure to respond led to a Warning Letter. The U.S. Food and Drug Administration (FDA) has now published another incident that also goes in this direction. The FDA had planned an inspection at a manufacturing facility in Thailand, but all efforts to contact the firm were unsuccessful.

The list of available reference standards is revised and published at regular intervals on the website of the EDQM. This comprises more than 3100 substances, including not only chemical reference substances but also herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials in accordance with Ph. Eur. methods.