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WHO Good Pharmacopoeia Practices Initiative - 03 Jul 2013

The WHO started the new initiative "Good Pharmacopoeia Practices" with the goal to harmonise the procedures and the regulations for pharmaceutical standards.  It is intended 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 so far presented challenges and difficulties.  A prospective harmonisation appears to be easier to accomplish under ICHQ4B.  The outcome of this initiative is 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.  

http://www.who.int/medicines/areas/quality_safety/quality_assurance/GPhP-ConceptPaper-QAS13-518Rev1_03052013.pdf

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