TOPICS : 02- QUALITY, SAFETY & ENVIRONMENT  / 01. Is the EDQM certified according to ISO standards?  

The EDQM is ISO 9001 certified for the following activities:

• Evaluation of applications (initial, revisions and renewals) for certificates of suitability to the monographs of the European Pharmacopoeia, granting of certificates, and management of the inspection programme of manufacturing sites and associated brokers”.

• Planning, implementation and coordination of post-marketing surveillance studies for medicinal products authorised by the centralised (CAP) and national (MSS studies) procedures;

• Management of the database related to post-marketing surveillance studies of medicinal products authorised by the mutual recognition (MRP) and decentralised (DCP) procedures and management of related interactions with users;

• Coordination of the elaboration and issuance of guidelines related to the OCABR procedure for the release of batches of human immunological medicinal products (blood and vaccine);
according to the pharmaceutical legislation, notably directives 2001/82/EC and 2001/83/EC, as amended, and Regulation 726/2004 (EC) for the EU countries;

• Management of the elaboration, revision, correction and suppression of European Pharmacopoeia texts, their publication in printed and electronic format, as well as their distribution. 

View the ISO certificate

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