Merging ISO 9001 and cGMPs: Models for Pharma Already Exist

FDA has just released a guidance document (FDA Quality Systems Document )for implementing a "Quality Systems" approach to GMP regulations, focusing on 21 CFR parts 210 and 211.  One key point is that cGMP regulations should be harmonized, as much as possible, with other widely used quality management systems, including ISO 9000 and FDA's own medical device quality system regulations. "With the globalization of pharmaceutical manufacturing, and the increasing prevalence of drug- and biologic-device combination products, the convergence of quality management principles across different regions and among various product types is very desireable." FYI.  Some models already exist, although you may not have heard of them.  One is ISO 15378:2006, in force since March, and developed for primary pharmaceutical packaging.  It took five years to take shape, and involved input from GMP experts in Europe, in the U.S. as well as a top former inspector for the MHRA. The standard will eliminate contamination, mixups and errors by establishing a benchmark that includes cGMP requirements for documentation, benchmarking, training, auditing and certification. Some of its language can even be applied to secondary packaging. Tabriz Consulting's director, Afshin Hosseiny, formerly with Glaxo-Smith-Kline,  and his colleague Tony Harper, both of whom were very closely involved in developing the new ISO standard's language,  offer a training seminar on this topic next month in Barcelona that's worthy of note. And, Hosseiny says, there was even a precedent for this standard with PS9004, a guidance doc that harmonized ISO and GMP language. (File was too big to upload here, so visit this link to get it). For additional information, visit -AMS