The ongoing collaboration on good manufacturing practice (GMP) inspections of active substance manufacturers between the European Medicines Agency and its international partners is to be expanded to include additional partners, according to new terms of reference, published today.

The World Health Organization (WHO) has already become a new partner in this collaboration, through its Prequalification of Medicines Programme. The international collaboration initiative allows participants to share information on inspections, including planning, policy and reports, for manufacturers of active pharmaceutical ingredients that are located outside the participating countries. It also allows joint inspections to take place.

Prior to the recent expansion, the programme involved the European Medicines Agency, EU Member States, the European Directorate of the Quality of Medicines and Healthcare (EDQM), the United States Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). The EU Member States had signed a confidentiality agreement with the FDA prior to taking part in the programme.

Based on the positive experience from a pilot running from December 2008 until December 2010, the participants agreed to continue with the collaboration, taking into account the lessons learned during the pilot.

Source: EMA Press Release

Related GMP News
04/04/2013	MHRA implements new Software for risk based Inspection Planning
27/02/2013	Are 300 GMP Inspections necessary by 2 July 2013?
20/02/2013	India opens Drug Inspection Office in China
13/02/2013	Up to $190.389 for FDA's New Inspections Fees
12/12/2012	Swiss GMP standards and inspection equivalent to EU