PharmOut – GMP and Validation Blog

FDA several steps closer to becoming PICS/S members

December 1st, 2009

An interesting press release was issued by PIC/S last month, commenting on the results of a PIC/S assessment team visit to the FDA: ” more progress was achieved during these
two weeks than during the previous three years of assessment. The team assessed the US GMP inspection system and also observed inspections carried out by FDA inspectors. It also met with FDA Commissioner, Dr. Margaret Hamburg, who stated that PIC/S membership was a top priority for the FDA.”!

This is exciting news for pharmaceutical and medical device manufacturers who must comply with multiple regional regulations and country-specific regulations. At long last, there may be an end in sight to the wasting of valuable time and resources in complying with multiple regulations rather than building quality and patient safety into the product. A global GMP standard may actually be achieved in my lifetime!

Whilst it’s great news that the FDA is moving closer to PIC/S membership, it would be a real shame they throw out all their regulations / guidance documents in the process. For example the draft “Process Validation Guidance” issued by the FDA last year provides a refreshing look at product development, commissioning and control. It outlines a whole life cycle development approach to product quality and risk management. So much better than the old three golden batches, how can three consecutive batch “prove” that your process is control! If the FDA does become a PIC/S member, I hope that PIC/S can pick up the best of the FDA’s work and integrate it into their own regulations and guidance documents.

It is interesting to note that there are now thirty seven PIC/S member countries. The membership applications of Indonesia / NADFC, Slovenia / JAZMP and Thailand’s FDA were recently reviewed, potentially expanding the number further. The next assessment for membership will be Latvia’s State Agency of Medicines (ZVA).

Entry Filed under: GMP