GMP News - APIs and Excipients

The German Federal Institute for Risk Assessment has issued a new statement recommending that the assessment of hemp-based food products be based on the EFSA-derived acute reference dose of 1 microgram Δ9-THC/kg body weight.

The Higher Regional Court (OLG) of Hamburg has decided, in the context of proceedings aimed at the issuance of an interim injunction against a wholesaler, that medical cannabis (cannabis flowers) is not (yet) a medicinal product at the wholesale level.

Version 14 of the "How to do" Document - Interpretation of the ICH Q7 Guide and "Review form" for APIs, which has been available since the beginning of the year, mainly includes additions and updates in the chapters 11, 15 and 16. The How to do document is intended to facilitate the implementation of the ICH Q7 Guide and lists recommendations on how to interpret it.

Extracts or isolates containing Cannabidiol are used in cosmetics and food supplements supplied to the UK market. One question still remains: How to interprete the 1 mg UK limit for controlled cannabinoids?

The "Q&A" documents for centralised procedures were revised and published on the EMA website in January. In general, pre- and post-approval advices regarding centralised procedures are given and specially information for applicants of generic or hybrid medicinal products is mentioned. 

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.