Highlights 2023 – EDQM annual report

The 2023 annual report of the European Directorate for the Quality of Medicines & HealthCare comes to you exclusively online for the very first time. All the essential information on our organisation’s activities and efforts to further public health protection in Europe and beyond is now only a few clicks away.

Message from
the Director

Hear from Petra Doerr, EDQM Director, on this year's report.

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Achievements

Our impact in public health protection.

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Co-operation with
international partners

GUIDELINE/DOCUMENT DE RECOMMANDATION	STATUT	GUIDELINE
Préface et avis aux lecteurs et lectrices des documents MQ	Adopté	Notes explicatives
« Interpretation of Screening Results for Unknown Peptides and Proteins by Mass Spectrometry based Methods »	Adopté	Document de recommandation
« Qualification of Equipment » – document de base	Adopté	Guideline
Annexe I de « Qualification of Equipment » – « Qualification of LC Equipment »	Adopté	Guideline
Annexe VII de « Qualification of Equipment » – « Qualification of Mass Spectrometers »	Adopté	Guideline
Annexe VIII de « Qualification of Equipment » – « Qualification of Balances »	Adopté	Guideline
« Management of OMCL Network Documents and Records by the EDQM »	Publié	Procédure
Annexe VI de « Qualification of Equipment » – « Qualification of Piston Pipettes »	En cours de révision	Guideline
Annexe 3.4 de « Evaluation and Reporting of Results » – « Special Considerations for Animal Testing in Connection with Verification of Out-Of-Specification Results »	En cours de révision	Guideline

Guideline/Recommendation document	Status	Guideline
Preface and Notes for Use of QM Documents	Adopted	Explanatory notes
Interpretation of Screening Results for Peptides and Proteins by Mass Spectrometry-based Methods	Adopted	Recommendation document
Qualification of Equipment – Core Document	Adopted	Guideline
Annex I to Qualification of Equipment – Qualification of PC Equipment	Adopted	Guideline
Annex VII to Qualification of Equipment – Qualification of Mass Spectrometers	Adopted	Guideline
Annex VIII to Qualification of Equipment – Qualification of Balances	Adopted	Guideline
Management of OMCL Network Documents and Records by the EDQM	Published	Procedure
Annex VI to Qualification of Equipment – Qualification of Piston Pipettes	Under revision	Guideline
Annex 3.4 to Evaluation and Reporting of Results: Special Considerations for Animal Testing in Connection with Verification of Out-Of-Specification Results	Under revision	Guideline