New WHO Initiative "Good Pharmacopoeial Practices"

Recommendation

6/7 February 2020
München, Germany

Quality Control of Starting Materials (APIs and Excipients)

The WHO started the new initiative "Good Pharmacopoeia Practices" with the goal to harmonise the procedures and the regulations for pharmaceutical standards. It is supposed to support authorities in ensuring the quality of pharmaceutical raw materials and finished products.

The background for the initiative is that the retrospective harmonisation of pharmacopoeia requirements has proven to be difficult. A prospective harmonisation seems to be easier to accomplish. In the end the initiative is supposed to result in the harmonisation of pharmacopoeia standards.

Representatives of all pharmacopoeias are involved in this activity.

The WHO working document comprises an agenda with the planned activities. For instance, in June 2013 it was planned to discuss the feedback that was submitted with regard to the concept paper.

For more detailed information please see the concept paper "Good Pharmacopoeia Practices".