"Universal" GMPs?

Since the early 1990s, regulatory agencies and pharmaceutical manufacturers have understood the benefit of regulations that are "harmonized" - that is, different regulatory agencies around the world having the same requirements and interpreting them in a similar way.

With one notable exception (ICH’s Q7, discussed below), there is not one set of GMPs world-wide that is used by all manufacturers. Some large, multi-national manufacturers have established their own, internal harmonized GMPs, often taking the most restrictive regulatory requirements and making those their internal goals.

From a regulatory standpoint, firms must follow the GMP requirements for the country (or region) that the product is marketed in. In some cases, that means that a firm may need to do a test (e.g., sterility) two different ways.

The International Conference on Harmonization or ICH is the group of regulatory officials and industry experts from the EU, Japan, and the U.S. that are working on this. One of the four sets of documents, those dealing with "quality," is most related to GMP topics. These documents are adopted as guidelines or annexes to help interpret GMP requirements.

The first set of GMPs with international acceptance is that for active pharmaceutical ingredients (APIs). The primary document that was written by the ICH (and the competent authorities and industry experts from Japan, the E.U., and U.S) and has been adopted as requirements by regions and countries, such as the E.U. and its member states, Japan, Switzerland, Australia, Canada, and the U.S.

There are two other sets of GMPs that are important internationally.

The first is from the Pharmaceutical Inspection Convention / Pharmaceutical Inspection Cooperation Scheme or PIC/S. This association of regulatory agencies exists to contribute to a more consistent understanding of GMP in counties and regions. It has published a variety of guidance documents to GMP, as well as a set of GMPs. PIC/S’ GMPs are very similar to the GMPs published by the EMEA in Europe.

The second set of internationally important GMPs are published by the World Health Organization or WHO. Their website provides GMPs as well as other technical reports/guidelines written by experts world-wide.