TOPICS : 02- QUALITY, SAFETY & ENVIRONMENT / 01.What is the scope of the EDQM ISO 9001 certificates?  

The EDQM is ISO 9001:2015 certified for the following activities:

• Evaluation of applications for certificates of suitability to the monographs of the European Pharmacopoeia and management of the inspection programme of manufacturing sites and associated brokers”.;

• Planning, implementation and coordination of post-marketing surveillance studies for medicinal products and management of related databases;

• 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 vaccines);

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

• Conduct of laboratory studies.

View the ISO certificate

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