GMP News - APIs and Excipients

The European Medicines Agency (EMA) has updated its list of questions and answers on the GMP/GDP guidelines. The newly added chapter deals with the requirements for active substances used as starting materials in veterinary medicinal products. Among other things, it is clarified that the Veterinary Medicines Regulation requires manufacturers and importers of veterinary medicinal products to perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances.

EMA´s HMPC published the HMPC Work plan for 2022. Amongst others, the HMPC plans to establish a Guidance on New Manufacturing Techniques addressing, for example, supercritical CO2-extracts.

EMA´s HMPC published the concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin. Amongst others, the revision will address the need for clarification regarding GMP vs GACP.

In February 2022, the U.S. FDA issued a Warning Letter (WL) to an Indian drug manufacturing site called "Indiana Chem-Port" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

How can you stay up to date with the ongoing changes in the GMP world? This question is frequently addressed during ECA courses and conferences. ECA´s weekly GMP Newsletter informs you about all relevant updates in the GxP arena.

EMA´s Herbal Medicinal Products Committee (HMPC) released the minutes for the HMPC meeting held in November 2021. Amongst others, the HMPC noted three new Ph. Eur. Cannabis Monographs for flowers and extracts in the pipeline. Other relevant topics were nitrosamines, GACP revision and elemental impurities in herbal medicinal products.

In January 2022, the U.S. FDA issued a Warning Letter to an Indian drug manufacturing site called "Aurobindo Pharmaceutical Limited" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).