information exchange and international collaboration in quality testing richard wanko interregional...

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)


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


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



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



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


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


Other Tested ProductsOther Tested Products

Cosmetics

Medical devices

Diagnostics

Food

Feed (premixes) for veterinary use

“Borderline products”


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


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


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


Tools of a NetworkTools of a Network

Policy and Technical documents

Terms of Reference

Procedures

Guidelines

Position Papers ...

Establishment of rules1/6



Human Resources

Expert Working Groups for elaboration of rules

Advisory Board for consultation

Committee for decision taking

Secretariat for coordination

Implementation of rules2/6



Common QA standards

Reference to the same quality standards

Audit of the QA/QM system

Proficiency Testing Scheme (PTS)

Harmonisation and standardisation3/6



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



IT platforms

Group E-mailing lists

Electronic document deposit sites with regulated (restricted) access

Knowledge databases

Safe distribution of information 5/6



Training

Technical and QA training

IT training

Tutorials

Training visits

Improvement of competence6/6


GEONGEON

General European Official Medicines Control Laboratory Network

=> Concerted effort in medicines control


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


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


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


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


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)


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).


« 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.


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


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


GEON Technical DocumentsGEON Technical Documents

Procedures

Guidelines OCABR Guidelines QA


OMCL Network HandbooksOMCL Network Handbooks


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


Example OMCLnetExample OMCLnet


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


Example OMCL Inventory DatabaseExample OMCL Inventory Database


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


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


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


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


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


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


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


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


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


GEON StructureGEON Structure


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


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…


Conclusion – Why Networking?Conclusion – Why Networking?

ENLARGEMENT OF THE HORIZON


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]

information exchange and international collaboration in quality testing richard wanko interregional...

Documents

quality control laboratories

laboratory testing

testing projects

respective sampling

european parliament

veterinary medicinal

current version slide

analysis support