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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009 * | MJA / MJV Scheme of the OMCL Network Marta Miquel Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009 3-6b MJA: Mutual Joint Audits MJV: Mutual Joint Visits   The Official Medicines Control Laboratory (OMCL) Network was established in the mid 90s with the purpose of harmonisation of practices and mutual recognition of the control tests performed at national level. In order to have confidence and recognise results from other labs = a harmonised approach is needed throughout when planning, performing and reporting the testing activities = harmonised Quality Management Systems (QMS). INTRODUCTION The MJA/MJV Scheme was created with the aim of: MJV: helping OMCLs implementing a QMS if not yet in place, or giving recommendations for improvement if QMS is under development. MJA: once the QMS is established, its compliance is periodically verified with respect to the agreed requirements stated in: ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories. OMCL guidelines (supplement ISO/IEC 17025, e.g. validation of analytical methods, uncertainty of measurement, qualification of equipment, etc). MJA are comparable to the audits performed by National Accreditation Bodies. ...because the team of assessors is composed of: members of the OMCL Network, competent in the field to be audited and trained for the quality audit = OMCLs audit “each other” = mutually 1 coordinator from EDQM: also trained for the quality audit, ensuring a homogeneous approach and responsible for the administrative work. Why “Mutual” ? Differences MJV / MJA ? MJV MJA Objective: give recommendations for implementation and/or improvement of QMS Objective: to check compliance of the QMS with the agreed and established sta