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Information Exchange and International Collaboration in Quality
Testing
Richard Wanko
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
3-2
Sampling and testing for Quality Control Laboratories, Nairobi, September 20092 |
OutlineOutline
Definition and role of OMCLs
Why collaboration between OMCLs / Why networking?
How does a network operate?
Which tools facilitate information exchange and collaboration?
Example of the General European OMCL Network (GEON)
Sampling and testing for Quality Control Laboratories, Nairobi, September 20093 |
Definition of an OMCL in EuropeDefinition of an OMCL in Europe
An Official Medicines Control Laboratory (OMCL) is a public institution, which only performs laboratory testing for a Competent Authority, independently from the manufacturer, for medicinal products prior to and/or after marketing for the general surveillance of medicines in relation to the safety of human patient and/or animals.
Reference: PA/PH/OMCL (07) 89, current version
Sampling and testing for Quality Control Laboratories, Nairobi, September 20094 |
OMCL as Recognised Term in EuropeOMCL as Recognised Term in Europe
The Term “Official Medicines Control Laboratory” can be found in several articles of the EU legislation
Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended
Article 19; Procedures relevant for marketing authorisation
Articles 111 and 114; Supervision and Sanctions 1/3
Sampling and testing for Quality Control Laboratories, Nairobi, September 20095 |
OMCL as Recognised Term in EuropeOMCL as Recognised Term in Europe
Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, as amended
Article 23; Procedure for marketing authorisation
Articles 80 and 82; Supervision and Sanctions
2/3
Sampling and testing for Quality Control Laboratories, Nairobi, September 20096 |
OMCL as Recognised Term in EuropeOMCL as Recognised Term in Europe
Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Article 7 / 32 Article 57
3/3
Sampling and testing for Quality Control Laboratories, Nairobi, September 20097 |
Role of an OMCL in EuropeRole of an OMCL in Europe
Post-marketing surveillance programme
Sampling and testing of generic medicines
Analysis of unlicensed (unauthorised) medicines
Analysis of illegal copies (counterfeits / falsifications)
Pre-marketing sampling and analysis
Support in evaluation of the quality part of MA files
Support of pharmacovigilance assessments
Support of GMP inspections as experts
Support in the framework of the European Pharmacopoeia
Evaluation of defect reports
Sampling and testing for Quality Control Laboratories, Nairobi, September 20098 |
Other Tested ProductsOther Tested Products
Cosmetics
Medical devices
Diagnostics
Food
Feed (premixes) for veterinary use
“Borderline products”
Sampling and testing for Quality Control Laboratories, Nairobi, September 20099 |
Why Should OMCLs Collaborate?Why Should OMCLs Collaborate?
Lab equipment and qualified manpower becomes more and more expensive – pooling of resources
Testing becomes more and more complex – centres of expertise / know-how
Workload is increasing – by sharing work the “coverage rate” of medicines available on the market becomes higher
Globalisation increases danger of inferior quality – cross boarder co-operation
Sampling and testing for Quality Control Laboratories, Nairobi, September 200910 |
Why Having a Network?Why Having a Network?
To promote and facilitate Mutual Recognition by developing codified procedures
To provide a platform for exchange of information on evaluation and status of products
To foster the use of harmonised approaches to the control of medicinal products
To create a unified voice for feedback and exchange with Regulatory Authorities, GMP inspectors, Pharmacovigilance experts and Manufacturers / within the Pharmacopoeia Expert Groups
To facilitate work-sharing and maximisation of resources
Sampling and testing for Quality Control Laboratories, Nairobi, September 200911 |
Basic Principle of NetworkBasic Principle of Network
Mutual Recognition
Implies
Common harmonised work procedure
Same rules of decision for compliance / non compliance
Work-sharing
Common QA systems and technical competence indicators / performance measurements
=> Need for a structured Network with codified rules
Sampling and testing for Quality Control Laboratories, Nairobi, September 200912 |
Tools of a NetworkTools of a Network
Policy and Technical documents
Terms of Reference
Procedures
Guidelines
Position Papers ...
Establishment of rules1/6
Sampling and testing for Quality Control Laboratories, Nairobi, September 200913 |
Tools of a NetworkTools of a Network
Human Resources
Expert Working Groups for elaboration of rules
Advisory Board for consultation
Committee for decision taking
Secretariat for coordination
Implementation of rules2/6
Sampling and testing for Quality Control Laboratories, Nairobi, September 200914 |
Tools of a NetworkTools of a Network
Common QA standards
Reference to the same quality standards
Audit of the QA/QM system
Proficiency Testing Scheme (PTS)
Harmonisation and standardisation3/6
Sampling and testing for Quality Control Laboratories, Nairobi, September 200915 |
Tools of a NetworkTools of a Network
Joint testing programmes
Collaborative studies (more technique-related exercise)
Market surveillance studies (more-product related exercise)
Testing of products based on the same Marketing Authorisation dossier
Work-sharing4/6
Sampling and testing for Quality Control Laboratories, Nairobi, September 200916 |
Tools of a NetworkTools of a Network
IT platforms
Group E-mailing lists
Electronic document deposit sites with regulated (restricted) access
Knowledge databases
Safe distribution of information 5/6
Sampling and testing for Quality Control Laboratories, Nairobi, September 200917 |
Tools of a NetworkTools of a Network
Training
Technical and QA training
IT training
Tutorials
Training visits
Improvement of competence6/6
Sampling and testing for Quality Control Laboratories, Nairobi, September 200918 |
GEONGEON
General European Official Medicines Control Laboratory Network
=> Concerted effort in medicines control
Sampling and testing for Quality Control Laboratories, Nairobi, September 200919 |
GEON – Some FactsGEON – Some Facts
Network created in 1994/1995
About 70-80 OMCLs from (almost) all Ph.Eur. signatory states and some observer countries (about 35 countries)
Financial support from EU
Sharing of work, equipment, competences
Aims for– Common rules, working and Quality Assurance standards– Mutual confidence and recognition of results
Sampling and testing for Quality Control Laboratories, Nairobi, September 200920 |
Rules of the GEONRules of the GEON
Defined in Terms of Reference, which includes
Core document
Annex 1: Definition of an OMCL and OMCL status within the GEON
Annex 2: Factors for determining OMCL status within the GEON
Annex 3: List of Network Members Reference: PA/PH/OMCL (07) 79, 89, 90 and (09) 45 current version
Sampling and testing for Quality Control Laboratories, Nairobi, September 200921 |
GEON Membership CriteriaGEON Membership Criteria
Guarantee of independency / independent judgement
Public funding
Avoidance of conflict of interest
Implementation of Ph.Eur.
Clear mandate as to responsibilities and duties
Clear rules for subcontracting activities
Implementation of the ISO/IEC 17025 standard
Sampling and testing for Quality Control Laboratories, Nairobi, September 200922 |
Types of GEON MembershipTypes of GEON Membership
Full member
Associated member
OMCLs of countries inside or outside of Europe that are observers to the European Pharmacopoeia Commission (Morocco, Canada, Australia)
Recent candidates for membership: the former Yugoslav Republic of Macedonia, the Russian Federation, Israel
Sampling and testing for Quality Control Laboratories, Nairobi, September 200923 |
The Ph.Eur. MembersThe Ph.Eur. Members
37 Members including Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, the former Yugoslav Republic of Macedonia, Turkey, United Kingdom, and the European Union.
Most recent member: Poland (2006)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200924 |
The Ph.Eur. ObserversThe Ph.Eur. Observers
23 Observer states including the World Health Organisation plus 8 European countries (Albania, Armenia, Belarus, Georgia, Kazakhstan, Moldova, Russian Federation and Ukraine) and 14 non-European countries (Algeria, Argentina, Australia, Brazil, Canada, China, Israel, Madagascar, Malaysia, Morocco, Senegal, Syria, Tunisia, United States of America).
Last observerships: Argentina, Armenia and Moldova (2008), Republic of Belarus (2007), the Russian Federation and Kazakhstan (2006).
Sampling and testing for Quality Control Laboratories, Nairobi, September 200925 |
« Specific » GEON Members« Specific » GEON Members
Control laboratories acting as OMCL of the Competent Authority due to lack of such institutions or specific technical competences
Precondition
All other GEON Membership criteria must be fulfilled
Funding only by the mandating authority
Laboratory acts exclusively as control laboratory of this authority
Authority transfers the responsibility for the given field of activity to that laboratory and the activity is not of an occasional nature or restricted to a specific analytical technique or product.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200926 |
GEON MeetingsGEON Meetings
Annual Meeting of the GEON once a year in a member state (principle of rotating location) - decision taking body
GEON Advisory Group twice a year at the EDQM - advising body
GEON Working Groups ad-hoc meetings upon request - Elaboration of (technical / QA) documents
EDQM – Secretariat of the GEON
Sampling and testing for Quality Control Laboratories, Nairobi, September 200927 |
Other Regular Network MeetingsOther Regular Network Meetings
Specific Networks
Annual Meetings of the CAP and OCABR testing groups
Advisory Groups for CAP testing and OCABR testing
No Advisory Group for MRP/DCP testing, but plenary meetings twice a year
Sampling and testing for Quality Control Laboratories, Nairobi, September 200928 |
GEON Technical DocumentsGEON Technical Documents
Procedures
Guidelines OCABR Guidelines QA
Sampling and testing for Quality Control Laboratories, Nairobi, September 200929 |
OMCL Network HandbooksOMCL Network Handbooks
Sampling and testing for Quality Control Laboratories, Nairobi, September 200930 |
OMCL Network IT ToolsOMCL Network IT Tools
Extranet sites OMCLnet, CAPnet, MRPnet, OCABRnet as document deposit with regulated access
Storage of
Network documents (policy and technical documents)
Reports
Meeting files (presentations, agendas, minutes...)
Training files
Sampling and testing for Quality Control Laboratories, Nairobi, September 200931 |
Example OMCLnetExample OMCLnet
Sampling and testing for Quality Control Laboratories, Nairobi, September 200932 |
OMCL Network IT ToolsOMCL Network IT Tools
Databases OMCL inventory database, MRP/DCP product testing database, OCABR batch database as data pool
Information about
OMCLs
Competences
Testing activities
Test results
Sampling and testing for Quality Control Laboratories, Nairobi, September 200933 |
Example OMCL Inventory DatabaseExample OMCL Inventory Database
Sampling and testing for Quality Control Laboratories, Nairobi, September 200934 |
Network Training - ExamplesNetwork Training - Examples
Training of users of the MRP/DCP product testing database and OCABR batch database
Training of auditors for the MJA programme
Counterfeit training for OMCLs
OCABR training for OMCLs
Sampling and testing for Quality Control Laboratories, Nairobi, September 200935 |
GEON QA ProgrammeGEON QA Programme
Mutual Joint Audits (MJA)
Peer assessment of the QA system against ISO 17025
Mutual Joint Visits (MJV)
Peer assistance to establish QA system according to ISO 17025
1/2
Sampling and testing for Quality Control Laboratories, Nairobi, September 200936 |
GEON QA ProgrammeGEON QA Programme
Tutorials
Peer assistance targeting specific test methods / techniques
Proficiency Testing Scheme
Tailor-made programmes for chemical and biological OMCLs
New in the programme: PTS for radiopharmaceuticals
Analysis of suspicious unknown product (SUP) 2/2
Sampling and testing for Quality Control Laboratories, Nairobi, September 200937 |
Activities of the GEONActivities of the GEON
General Activities
Elaboration of common network strategies
General QA activities
Market surveillance and collaborative studies
Educational programmes
Applied analytical research and regulatory development1/2
Sampling and testing for Quality Control Laboratories, Nairobi, September 200938 |
Activities of the GEONActivities of the GEON
EU-specific Activities
Centrally Authorised Product (CAP) testing
Official Control Authority Batch Release (OCABR)
Mutual Recognition Procedure/Decentralised Procedure (MRP/DCP)-product testing
2/2
Sampling and testing for Quality Control Laboratories, Nairobi, September 200939 |
Role of the Secretariat (EDQM)Role of the Secretariat (EDQM)
General coordination of activities– Definition of an OMCL and membership to the Network– Clear rules and procedures
Fostering of mutual confidence and recognition– Implementation of QA system– Audits of OMCLs by peers (EDQM and Network members)– Proficiency testing studies (PTS)– Training courses (procedures, QA and techniques in OMCLs,
databases)– Assistance (tutorials, visits,…) 1/2
Sampling and testing for Quality Control Laboratories, Nairobi, September 200940 |
Role of the Secretariat (EDQM)Role of the Secretariat (EDQM)
Organisation batch release for biologicals– Elaboration of guidelines
Organisation post-marketing surveillance studies (CAPs, MRPs, DCPs, nationally authorised medicines)
Supply of tools (databases, IT platforms etc.)
2/2
Sampling and testing for Quality Control Laboratories, Nairobi, September 200941 |
Interaction National and European PartnersInteraction National and European Partners
Complementary,No Duplication,
InteractivityEMEAEvaluation Inspections
EU CommissionDG Enterprise
Legislation
EDQM (CoE) OMCL NetworkQuality Control
Reciprocal participation in expert groups
NATIONAL MEDICINES AGENCIES
Sampling and testing for Quality Control Laboratories, Nairobi, September 200942 |
An “Intercontinental Dimension “An “Intercontinental Dimension “
Complementary,Interactivity: work-sharingNo duplication, common
approaches
WHOStandards and
qualityEDQM is
collaborative centre of WHO for
antibiotics
EDQMKnow-how
Specific countries such as USA, JP,
Canada, Australia, Morocco,
EDQM provides assistance to Africa and
ASEAN countriesTwo-way participation in activities and studies
MEDICINES AGENCIESNATIONAL AUTHORITIES
Sampling and testing for Quality Control Laboratories, Nairobi, September 200943 |
GEON StructureGEON Structure
Sampling and testing for Quality Control Laboratories, Nairobi, September 200944 |
Contribution of the GEONContribution of the GEON
Activities of the GEON contribute to:
Public health and patient protection in field of medicines
Animal welfare
Economical use of resources – Cost efficiency = co-financing of projects of common interest
between interested stakeholders / partners (EU Commission, EMEA, WHO…), fees from industry
Sampling and testing for Quality Control Laboratories, Nairobi, September 200945 |
Conclusion – Why Networking?Conclusion – Why Networking?
Cost saving / Time saving
Quicker and better informed; better preparedness in case of incidences
Better / stronger positioning against other stakeholders (Pharmaceutical Industry)
Enlargement of capacity; higher sample throughput
Enlargement of expertise / know-how and…
Sampling and testing for Quality Control Laboratories, Nairobi, September 200946 |
Conclusion – Why Networking?Conclusion – Why Networking?
ENLARGEMENT OF THE HORIZON
Sampling and testing for Quality Control Laboratories, Nairobi, September 200947 |
http://www.edqm.euhttp://www.edqm.eu
Thank you for your attention
Dr Richard WankoScientific OfficerCouncil of EuropeEuropean Directorate for the Quality of Medicines and HealthCare (EDQM)Biological Standardisation, OMCL Network & HealthCare Department (DBO)
7 allee Kastner, CS 30026F- 67081 Strasbourg, FranceTel.: + 33 (0) 3 90 21 40 13Fax: + 33 (0) 3 88 41 27 71E-mail: [email protected]