EDQM 质量管理文件Quality Management (QM) Documents

Quality Management (QM) Documents

Quality Management (QM) documents have been developed for application within the General European OMCL Network. They are available to download below. They are recognised by the European co-operation for Accreditation (EA).

Introduction

· Preface and Notes for Use of OMCL Quality Management Documents

Guidelines

· Sub-Contracting of Tests

· Sub-Contracting of Tests Annex I: Sub-Contractor Qualification

· Sub-Contracting of Tests Annex 2: OMCL Model Contract for Sub-Contracting

· 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

· Evaluation & Reporting of Results – Core Document

· Evaluation & Reporting of Results – Annex 1A: Model Template for Failure Investigation of OOS Results

· Evaluation & Reporting of Results – Annex 1B: Resp**ibilities of the Laboratory Supervisor

· Evaluation & Reporting of Results – Annex 2A: Examples of Re-Test Programmes for Quantitative Tests

· Evaluation & Reporting of Results – Annex 2C: Re-Test Programmes for Qualitative Tests

· Evaluation & Reporting of Results – Annex 2D: Special C**iderati** for Animal Testing (Verification of OOS Results)

· 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

· Qualification of Equipment Annex 6: Qualification of Piston Pipettes

· Revised: Qualification of Equipment Annex 7: Qualification of Mass Spectrometers (comes into force on 1 August 2018)

· Qualification of Equipment Annex 8: Qualification of Balances

· Qualification of Equipment Annex 9: Calibration/Qualification of pH Meters

· Qualification of Equipment Annex 10: Qualification of Atomic Absorption / Atomic Emission Spectrometers

· Management of Documents and Records

· Revised: Validation of Computerised Systems - Core Document (comes into force on 1 August 2018)

· Revised: Validation of Computerised Systems Annex 1: Validation of Excel Spreadsheets (comes into force on 1 August 2018)

· Revised: Validation of Computerised Systems Annex 2: Validation of Complex Computerised Systems (comes into force on 1 August 2018)

· Management of Samples

· Management of Reagents

· Handling and Use of Non-Compendial Reference Standards in the OMCL Network

Recommendation documents

· Qualification of Analytical Columns

· Qualification and Requalification of Analysts 

· General Requirements for Infrequently performed techniques

· Management of Volumetric Glassware

· Management of Environmental Conditi**

· Interpretation of Screening Results for Unknown Peptides and Proteins by MS Based Methods

· Change Control

Other documents

· Standard ‘Aide-Mémoire’ for the Mutual Joint Audit of Official Medicines Control Laboratories

· 'Aide-Mémoire' for Environmental Conditi** & Treatment of Biological Models

· VBRN/ OCABR: 3R Issues for method validation and maintenance of competence