Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

Posted 04 April 2012 | By Alexander Gaffney, RAC 

An active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the member nations and advance "administrative simplification."

The as-yet-unnamed program, which includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the Council of Europe (CE), is also looking to expand.

As reported in In-Pharma Technologist and Regulatory Focus, the group recently published its Terms of Reference guidance which includes "pre-requisites for the inclusion of new partners."

"The overall objective is to foster greater international collaboration and information sharing to help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication," said the group in the Terms of Reference document.

The group plans to adhere to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)'s Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients guidance unless other guidances are merited on a case-by-case basis.

Read more:

In-Pharma Technologist - FDA welcomes joiners to API regulatory sharing scheme

FDA - Program to rationalize international GMP inspections of active pharmaceutical ingredients/active substances manufacturers

Regulatory Focus - Australia Proposes Ongoing API Inspection Cooperation

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