MJA / MJV Scheme of the OMCL Network

1. 3-6b 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

2. MJA: Mutual Joint Audits MJV: Mutual Joint Visits

3. INTRODUCTION • 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).

4. 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.

5. Why “Mutual” ? ...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.

6. Differences MJV / MJA ?

7. 58 MJA and 47MJV performed between Dec 1997 – Sept 2009 Pilot Phase

8. Assessed elements of the QMS Organisation (organisational charts, key positions, communication, Quality manual and quality policy, confidentiality agreements, independence, impartiality, absence of conflict of interests) Document control/Control of records(control of procedures and records, identification, approval, distribution, review, track of changes, retrieval, archiving) Review of requests, tenders and contracts(approval of test requests, evaluation of necessary resources to run the tests) Subcontracting of tests and calibrations(evaluation of subcontractors, related documentation) Purchasing services and supplies(evaluation of suppliers, related documentation, audits)

9. Assessed elements of the QMS (cont.) Feedback from the client(questionnaires, survey, evaluation of the outcome, corrective actions and follow up) Complaints (reception and treatment, corrective actions, follow up) Control of nonconforming testing work(policy for the resolution of OOS, retesting programme, responsibilities, follow up of corrective actions) Corrective/Preventive action(identification and application of actions, follow up) Internal audits(procedure, audit plan, audit reports, training of auditors, follow up of corrective actions) Management reviews(topics covered, final conclusion, follow up of actions)

10. Assessed elements of the QMS (cont.) Personnel (job descriptions, education, training, documentation) Facilities (adequate for the tests to be performed, monitoring, records) Test methods(adequate method validation, documentation) Equipment (qualification, certificates, records, labels) Measurement traceability(management of reference standards) Sampling (procedures, records) Handling of samples(traceability, storage conditions, unique identification) Participation in PTS Studies(results obtained, corrective actions, evaluation of performance) Reporting the results(information in the report, traceability, confidentiality)

11. Audit scopes 5 types of audit scope are possible: 1- Blank audit: all elements of the QMS are assessed. Findings lead to recommendations only. 2- Initial audit: all elements of the QMS are assessed. Findings lead to non-conformities: • The audited lab has to propose a corrective action plan. • The lab has to implement the corrective actions in due time. • A follow-up will be done by EDQM.

12. Audit scopes (cont.) 3- Surveillance audit: only specific areas of the QMS are assessed (e.g. specific lab methods, management of documentation, changes in personnel or equipment, in case of complaints, etc). Findings lead to non-conformities (as Initial audit). 4- Reassessment audit (at least every 3.5 years): all elements of the QMS are assessed. Findings lead to non-conformities (as Initial audit). 5- Follow up of non conformities: follow-up of a previous MJA to check the implementation of the corrective actions.

13. QMS implementation steps 12-18 months If quick progress is made, Blank Audit can be skipped 12-18 months max. 3,5 years

14. Audit Attestation

15. Frequent findings during MJA/MJV within the OMCL Network (with respect to requirements of ISO/IEC 17025 and OMCL guidelines)

16. General findings

17. General findings (cont.)

18. Technical findings

19. Technical findings (cont.)

20. Technical findings (cont.)

21. http://www.edqm.eu Thank you for your attention Marta Miquel Scientific Officer Council of Europe European Directorate for the Quality of Medicines and HealthCare (EDQM) Biological Standardisation, OMCL Network & HealthCare Department (DBO) 7 Allée Kastner, CS 30026 F- 67081 Strasbourg, France Tel.: + 33 (0) 3 90 21 42 41 Fax: + 33 (0) 3 88 41 27 71 E-mail: marta.miquel@edqm.eu