As reported by in-Pharma Technologist a couple days ago, ENVI has again proposed GMP requirements for excipients. The European Fine Chemical Group (EFCG) endorses the concept at a broad level as a means of further assuring patient safety. EFCG cautions that regulations must still balance risk and benefit. EFCG would like any final regulation to specifically target trouble areas within excipients and not paint with a broad brush. EFCG emphasizes that excipients should not be regulated the same as APIs as this would impose an undue burden on excipient manufacturers. The current draft of the guidelines does not make this distinction clear.
These guidelines, if adopted, just further the trend toward greater scrutiny and management of the pharmaceutical supply chain. It is in keeping with requests by pharma manufacturers (and regulators) for their suppliers to better understand their products and processes, as I've previously written. I am in agreement with the EFCG contention that excipients and APIs should not be regulated exactly the same and new proposals should take a balanced view in line with the level of risk involved.
Posted by Bruce Lehr Feb 10, 2010