QUALITY MANAGEMENT (QM) GUIDELINES
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Quality Management Guidelines
Quality Management (QM) guidelines have been developed for application within the General European OMCL Network. They are available to download below.
Those marked with an asterisk* have been approved by the European co-operation for Accreditation (EA).
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Scope of Accreditation of Official Medicines Control Laboratories*
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Standard ‘Aide-Mémoire’ for the Mutual Joint Audit of Official Medicines Control Laboratories*
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'Aide-Mémoire' for Environmental Conditions & Treatment of Biological Models*
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UPDATED: Qualification of Equipment Annex 1: Qualification of HPLC Equipment*
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Qualification of Equipment Annex 2: Qualification of GC Equipment*
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Qualification of Equipment Annex 3: Qualification of UV-Visible Spectrophotometers*
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Qualification of Equipment Annex 4: Qualification of IR Spectrophotometers*
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UPDATED: Qualification of Equipment Annex 5: Qualification of Automatic Titrators*
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Qualification of Equipment Annex 6: Qualification of piston pipettes*
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NEW: Qualification of Equipment Annex 7: Qualification of mass spectrometers
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Validation of Computerised Systems Annex 3: Validation of computers as part of test equipment*
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NEW: Handling and Use of Reference Standards in the OMCL Network PA/PH/OMCL (11) 204 3R
Important Information
For information about the Quality Management (QM) Programme, visit the Control of Medicines section.
Catalogue
EDQM Council of Europe
7 allée Kastner, CS 30026,
F67081 Strasbourg, France
Tel. +33 (0)3 88 41 30 30
Fax +33 (0)3 88 41 27 71
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