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      Organisation of sampling programmes
                                             EU experience

                                Jean-Marc Spieser / 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
     Sampling & Testing programmes within the OMCL Network


     The EDQM coordinates a series of (voluntary) collaborative programmes within the
      OMCL Network, with the aim of controlling the quality of medicinal products
      available on the European market:
             1. MSS (Market Surveillance Studies)
             2. MRP/DCP Post Marketing Surveillance Scheme (Mutual Recognition
                 Procedure/Decentralised Procedure)
             3. CAP Sampling and Testing Programme (Centrally Authorised Products)


     Advantages of having coordinated surveillance programmes:
        Sharing of work => avoid duplication of tests => save resources
        Exchange of information/results




2|     Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
         Sampling & Testing programmes within the OMCL Network

    In order to allow confidence, harmonisation and mutual recognition of results => a common approach
     is needed (when planning, performing and reporting the testing activities) => harmonised Quality
     Management Systems (QMS)


    Advantages of having a well established QMS
               processes/activities are under control => reduce the risk of errors.
               increases traceability of activities (possible to go back and find cause of error).
               increases confidence in test results => mutual recognition of results between labs/countries.
               facilitates cooperation/exchanges/harmonisation between labs.
               better use of resources => reduction of costs => labs can be more efficient.
               better protection of public health.




    3|     Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
     Sampling & Testing programmes within the OMCL Network

     With the purpose of establishing/maintaining harmonised QMS within the OMCL
      Network => EDQM coordinates 2 External Quality Assessment Programmes
      (voluntary, but participation is strongly recommended):


              – Audit/Visit/Training programme aimed to coach and help OMCLs establishing and
                improving their QMS (based on ISO/IEC 17025 and complementary OMCL
                guidelines, e.g. validation of analytical methods, uncertainty of measurement,
                qualification of equipment, etc).


              – PTS (Proficiency Testing Studies) aimed to provide the laboratories (within and
                outside the OMCL Network) with an objective and independent tool to demonstrate
                that the results they produce are accurate and reliable (regular comparison of a
                laboratory’s results at intervals with those of other laboratories).




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     Drug Quality Surveillance Programmes
                            within the OMCL Network

              1. MSS
              2. MRP/DCP
              3. CAP




5|   Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
                 1 - Market Surveillance Studies (MSS)

    Objective: control of the quality of the medicines (“screening”) on the European
     market, which are, as a rule, commercialised with a national marketing
     authorisation (MA).

    Products tested: different types of preparations of active ingredients, herbals...

    29 MSS have been finalised since the beginning of the programme, with an
     average participation of 12 OMCLs per MSS.

    Since 1995 a yearly MSS programme is elaborated by EDQM, based on
     proposals from:
               Advisory Group of the OMCL Network
               OMCLs (e.g. after detection of quality problems during routine analytical work)
               Inspectorates




6|    Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
                      Market Surveillance Studies (cont.)
Steps:
1.   EDQM collects MSS proposals => programme => adopted by OMCL Network (annual meeting).
2.   Head of MSS project appointed (normally from the proposing OMCL) => proposes the testing
     method (common protocol for all participants) + provides the Common Testing Sample.
3.   Protocol is verified by a second laboratory (EDQM Dlab or another OMCL).
4.   SAMPLING: participant OMCLs take samples along the distribution chain (wholesalers, retail
     pharmacies) from their national markets, in connection with the national competent services.
5.   Participant OMCLs test the samples according to the common protocol.
6.   In case of OOS, the product is retested using the method of the MA file.
7.   OMCLs send results to EDQM => statistical evaluation of results => MSS report.
8.   Subsequent actions and follow-up are the responsibility of the National Competent Authorities.
9.   If a Pharmacopeia issue is identified, the report is forwarded to the concerned EDQM Dpt.



7|     Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
                    Market Surveillance Studies (cont.)

 Examples of Market Surveillance Study:
             • Tablets and/or capsules containing lithium, tamoxifen, acyclovir, ibuprofen, lisinopril
               dihydrate, etc.
             • Erythromycin Liquid Preparations.
             • Omeprazole gastro-resistant tablets.
             • Procaine in aqueous solutions for injection.
             • Suspensions of dihydrostreptomycin or amoxicillin.
             • Cadmium in herbal drugs.
             • Studies on pharmaceutical technology (preparations for inhalation, uniformity of
               unidose preparations, tablets for which subdivision is authorised…).




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     2 - Post Marketing Surveillance Scheme of MRP/DCP

     Objective: control of the quality of medicinal products on the EU/EEA market (European
      Union/European Economic Area = 27 EU countries + Norway, Iceland, Liechtenstein) having
      received a MA through the Mutual Recognition Procedure (MRP) or the Decentralised
      Procedure (DCP) => identical MA dossier in all concerned member states (identical
      specifications and test methods).
     Yearly programme, regularly run since 2005 (Trial Phase 2000-2004). About 300
      medicinal products tested per year, including generics.
     More than 2300 MRP projects have been registered in a database (information
      shared) since 2000.
     2 basic principles of the Scheme:
            Work-sharing => to reduce duplication of testing => 1 single “testing lab”
            Exchange of test results => Database




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   Post Marketing Surveillance Scheme of MRP/DCP (cont.)

   Steps
   1.    Programme: OMCLs register in the database the product they plan to test. Tested
         material: approx. 2% APIs; 98% finished dosage forms. A risk based model for targeting
         medicinal products for market surveillance testing has been developed within the OMCL
         Network.
   2.    SAMPLING: the “testing OMCL” (or the Competent Authority of the Member State) takes
         samples from the national market. Other participating OMCLs might voluntarily send
         samples taken from their country to the testing OMCL.
   3.    Testing: tests are performed as a rule in one lab, according to MA dossier, or a method
         developed and validated by the OMCL (in-house method), or compendial methods.
   4.    Reporting: testing OMCL publishes the test results on the database.
   5.    Follow-up: follow-up measures are reported in the database. In general follow-up activities
         are the responsibility of the National Competent Authorities.



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            3 - CAP Sampling and Testing Programme

      Objective: control of the quality of medicinal products on the EU/EEA market, having
       received a MA valid throughout EU/EEA => Centrally Authorised Products “CAP”
       (according to regulation EC/726/2004) (about 550 CAPs are currently available).

      Unless a major issue is identified, CAPs are not tested by national authorities in their
       routine testing programmes.

      Since 1999 the EMEA (European Medicines Agency) has implemented a post-
       authorisation sampling and testing programme: CAP programme.

      As EMEA has no lab facilities => CAP programme is run by EDQM on behalf of EMEA, in
       collaboration with the EEA OMCL Network and the EEA National Inspection Services.

      354 CAP projects have been run since the beginning of the CAP programme.




11 |    Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
            CAP Sampling and Testing Programme (cont.)

Steps:
1) EMEA proposes the CAP programme => from 2010, products will be exclusively selected on the
   basis of a risk analysis, including a 5% of randomly selected additional products per year.
2) The MAH sends MA file and technical SOPs to EDQM.
3) EDQM prepares the testing protocol accord. to recommendations from the assessors (NCAs).
4) EDQM proposes the list of participating OMCLs => approved by the OMCL Network.
5) EDQM proposes a sampling plan based on the information received from the MAHs about the
   marketing situation
6) Sampling plan is sent to Inspectorates (sampling contact points).
7) SAMPLING is done along the distribution chain (preferably as closely as possible to patients) by
   the competent national services in 3 countries (1 batch per country => 3 batches).




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                 CAP Sampling and Testing Programme (cont.)

 Steps (cont.):


 8) Inspectors send samples to EDQM under the required transport conditions.
 9) EDQM requests the MAH to send 1 sample (control test sample) + reference materials.
 10) Samples are labelled at EDQM + dispatched to testing OMCLs (1 OMCL if chemical/physico-
     chemical tests are requested, 2 OMCLs if biological tests are requested) + protocol + Results
     Data Sheet + ref. materials + Safety Data Sheet + other info if required.
 11) OMCLs send back results to EDQM.
 12) EDQM prepares individual product report => sent to EMEA and the OMCL Network via a
     secured system.
 13) EMEA is responsible for the actions and follow up measures as an outcome of the results
     (feedback received from the assessors of the NCAs).




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MAHs                    CAP                           EDQM




                      ref.mat.

                                                                                          report
                                                                                                            EMEA

                    documentation                                                 protocol




                                                                         samples
                                                                                        ref. mat.




                                                                                                    OMCLs (testing)
                      National Inspectors (sampling)


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       Objective of the 3 programmes: survey of the quality of medicinal products


 Table of differences:
               1- MSS                                        2- MRP/DCP                                   3- CAP


National MA                                MA via MRP/DCP procedure                       MA via Centrally Authorised Procedure


Whole OMCL Network                         EU/EEA OMCL Network                            EU/EEA OMCL Network


Variable no. participants                  Variable no. participants                      Defined no. participants (1 OMCL for
(many testing OMCLs)                       (1 testing OMCL as a rule)                     chemical, 2 for biologicals)


Variable no. samples                       Variable no. samples                           Defined no. samples


Protocol established by the                Protocol based on the MA dossier +             Protocol based on MA dossier + SOPs
Head of the MSS project                    SOPs of manufacturer, or internal              from manufacturer
                                           method or compendial




15 |     Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
 Potential impact in case of confirmed OOS results:

        Major or minor variations in the marketing authorisation file (change of
         specifications of an active substance or finished product and/or change of
         method).

        Recall of a batch (in case of a confirmed quality defect).

        If European Pharmacopoeia methods are concerned:
             Revision of a monograph/general chapters and methods
             Establishment of a new method




16 |   Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
   For more information on EDMQ/OMCL Network programmes:


       MSS: http://www.edqm.eu/en/Market-Surveillance-Study-MSS-48.html
       MRP/DCP: http://www.edqm.eu/en/MRPDCP-Post-Marketing-Surveillance-Scheme-686.html
       CAP: http://www.edqm.eu/en/Centrally-Authorised-Products-Testing-CAP-613.html
       QA: http://www.edqm.eu/en/Quality-Assurance-Activities-19.html
       PTS: http://www.edqm.eu/en/Proficiency-Testing-Activities-PTS-47.html
       PTS programme 2009: http://www.edqm.eu/en/List-of-PTS-planned-for-2009-1251.html
       QA OMCL Guidelines: http://www.edqm.eu/en/Quality-Assurance-Activities-Guidelines-86.html




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                                    http://www.edqm.eu

                                    Thank you for your attention




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