GMP News - APIs and Excipients

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. Beside a whole series of general GMP violations, the authority in particular blames the company for failing to test the incoming component benzalkonium chloride (BZK).

Following the previously pre-published Ph. Eur. Cannabis Flower Monograph and the announced Ph. Eur. CBD Monograph, four new Ph. Eur. cannabis reagents are needed for quality control purposes. The description of these Cannabis reagents will be published in the European Pharmacopoeia (Ph. Eur.) Supplement 11.5.

In September and November 2023, the "Questions & Answers (Q&A)" documents relating to centralised authorisation procedures were revised once again 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 for centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

The supplement 11.4 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on the 1st of April 2024. According to the EDQM timetable, this supplement will be followed by versions 11.5 to 11.8, with the final implementation date planned for July 2025.

The U.S. Food and Drug Administration (FDA) has sent a new Warning Letter to a manufacturer located in South Korea. The firm manufactures over-the-counter (OTC) topical drug products, such as hand sanitizers. During an inspection, significant violations of Current Good Manufacturing Practice (CGMP) were found.

The USP Herbal Medicines Compendium (HMC) published a revised version of the previously proposed Cannabis Species Inflorescence monograph. In particular, the Content of Terpenes section has been removed from Specific Tests because there is insufficient information to support the use of terpenes for medical purposes.