Relationship between receiving authorities and monitoring authorities. The EMEA experience.
The approach of the European Medicines Agency (EMEA) to good laboratory practice (GLP) inspections in the context of authorization of medicinal products is illustrated with particular reference to the EMEA's experience as a receiving authority (RA), the procedures it has in place for the reporting and follow-up of GLP inspections, and the role of the ad hoc GLP inspectors working group. Other key issues dealt with are the relationship between the EU monitoring authorities (MAs) and the EMEA as a specific RA, how inspections outside the EU are handled and some aspects (exchange of information, handling of non-compliance, triggers for inspection) that have been raised during recent inspections.
Cuddy
Brendan James
BJ
European Medicines Agency, Inspections Sector, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. Brendan.cuddy@emea.europa.eu
D019411:Clinical Laboratory Techniques / Q000592:standards*; D005060:Europe; D007390:International Agencies; D012926:Social Control, Formal