(2003; 148 pages)
6.2 GMP guidelines for active pharmaceutical ingredients
The Committee was informed of the background to the development of the ICH GMP guidelines for active pharmaceutical ingredients (APIs), including the earlier involvement of the Pharmaceutical Inspection Cooperation Scheme in initiating the preparation of this guide.
The Committee recognized the difficulty that countries would have in implementing the ICH GMP guide in a short period of time. The Committee was informed that, from a legal standpoint, WHO cannot simply take over any GMP document from another source. The Committee therefore considered that it would be best for the current WHO GMP for APIs to be revised to reflect current GMP requirements.
The Committee agreed that WHO should review the current WHO GMP for APIs, taking into account other published guidelines, including the ICH document, and also consider current practices. The Committee endorsed the step-wise approach to the implementation of GMP for APIs.