International Collaboration on Good Manufacturing Practice Inspections expanded
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
02.07.2025EFPIA Report on Current Inspections
18.06.2025FDA Warning Letter with Supplier Qualification Observations
11.06.2025Root Cause Investigations criticised at EU Company
21.05.2025More FDA Warning Letters citing Quality Oversight
21.05.2025New Version of GMP Auditors Handbook available
21.05.2025FDA: more unannounced Inspections also outside the US