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QUALITY MANAGEMENT (QM) GUIDELINES
QM 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).
- Scope of Accreditation of Official Medicines Control Laboratories*
- Validation of Analytical Procedures*
- Uncertainty of Measurement-Part 1: General OMCL Policy for implementation of Measurement of Uncertainty in Compliance Testing*
- Uncertainty of Measurement-Part 2: OMCL Policy on the Estimation and Application of Uncertainty in Analytical Measurement
- Standard ‘Aide-Mémoire’ for the Mutual Joint Audit of Official Medicines Control Laboratories*
- 'Aide-Mémoire' for Environmental Conditions & Treatment of Biological Models*
- Evaluation & Reporting of Results
- REVISED: Qualification of Equipment - Core document*
- Qualification of Equipment Annex 1: Qualification of HPLC Equipment*
- Qualification of Equipment Annex 2: Qualification of GC Equipment*
- Qualification of Equipment Annex 3: Qualification of UV-Visible Spectrophotometers*
- Qualification of Equipment Annex 4: Qualification of IR Spectrophotometers*
- Qualification of Equipment Annex 5: Qualification of Automatic Titrators
- NEW: Qualification of Equipment Annex 6: Qualification of piston pipettes
- Validation of Computerised Systems - Core Document
- Validation of Computerised Systems Annex 1: Validation of Computerised Calculation Systems: Example of validation of in-house software
- Validation of Computorised Systems Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN)
- Validation of Computerised Systems Annex 3: Validation of computers as part of test equipment
- Archiving
Important Information
For information about the Quality Management (QM) Programme, visit the Control of Medicines section.
Catalogues
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