New WHO Initiative "Good Pharmacopoeial Practices"
Recommendation

17/18 November 2026
Heidelberg, Germany
Enhanced Approach using AQbD Principles
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".
Related GMP News
02.11.2026FDA Warning Letter: When Test Procedures Allow Retesting Until an Acceptable Result is Obtained
21.10.2026EMA Updates Information Page on Bioequivalence Guidelines
21.10.2026BP Publishes new Draft Texts
21.10.2026FDA Identifies Critical Deficiencies in Analytical Testing and CGMP Oversight
07.10.2026Analytical Quality Group Developments May through August 2026
07.10.2026Two New FDA Warning Letters Put OOS Investigations in Focus


