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Issuing a certificate of GMP compliance of a manufacturer under

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					                                MANUFACTURERS LICENSING SCHEME

Issuing a Certificate of GMP Compliance of a Manufacturer under the Provisions of the
Mutual Recognition Agreements Between Australia, the European Community and the
                           European Free Trade Association

                                              KP80_W11

1.    OBJECTIVE

To give detailed information on the procedure for issuing a Certificate of GMP Compliance of a
Manufacturer or providing other relevant information under the provisions of the Mutual Recognition
Agreement on Conformity Assessment (MRA) Between the European Community and Australia
(subsequently referred to as the EU-MRA) [http://www.tga.gov.au/international/ecmra.pdf] and the
Mutual Recognition Agreement on Conformity Assessment Between the European Free Trade
Association and Australia, (subsequently referred to as the EFTA-MRA)
[http://www.tga.gov.au/international/eftamra.pdf].


2.    SCOPE

This work instruction applies to all requests for a Certificate of GMP Compliance of a Manufacturer
for a licensed Australian manufacturer or providing other relevant information under either the EU-
MRA or the EFTA-MRA.

If a certificate is requested, the relevant Australian manufacturers must be inspected by the
Therapeutic Goods Administration (TGA) for compliance with the appropriate GMP code and then
certified by the APVMA.

Under the terms of the MRA, the relevant GMP Code used is the TGA’s Australian Code of GMP for
Medicinal Products. Where this code does not cover the requirements of the importing country, the
inspection should be carried out in accordance with the applicable GMP of the importing country (see
Clause 3 of Section III of the MRA Sectoral Annex). If a product or process audit is requested then the
audit will be conducted using the relevant specifications and standards listed in the Marketing
Authorisation granted by the importing Party (see Section I of the MRA Sectoral Annex).


3.    PROCEDURE

3.1   Records

Record correspondence and place all data, correspondence and forms on each related manufacturer
file. Record information in relevant audit tracking database and certificate databases.




 KP80_W11    Approved by:                              Version: 6                Page 1 of 4
                                                       Issue Date: 2/10/09

             Position: Manager, GMP Section
3.2     Processing Requests for a Certificate of GMP Compliance of a Manufacturer

3.2.1    Applicants must complete and submit form KP80-F39 Request for a Certificate of GMP
         Compliance of a Manufacturer issued under the provisions of the MRA between Australia
         and the European Community (EC).

3.2.2    The GMP Reviewer assesses the request form to ensure it contains all necessary information
         and letters of support. If more information is required, fax or write to the applicant to request
         this information. Enter the information in the Record List of MRA Certificates, located in
         folder O:\DEVPROJ\GMP\MRA_EU.

3.2.3    The Reviewer should check the relevant manufacturer file (M-xxx) for details of the last TGA
         audit. Unless the audit was recent (less than twelve months), the reviewer should consult with
         the nominated TGA contact to ensure that there have been no other more recent audits since
         the last one on file. A new TGA audit will be required if the last audit was more than three
         years ago or the facilities inspected or the scope of the audit was not consistent with the scope
         of the certificate requested.

3.2.4    A request for a Certificate of GMP Compliance of a Manufacturer may also be received from
         a Competent Authority of a Member State of the European Community, the European Free
         Trade Association or the European Medicines Agency (EMEA). In these cases, the relevant
         company must be approached and asked to complete the request form KP80-F39, unless there
         is sufficient information on file to proceed with the request. Requests from overseas
         authorities should be responded to as a priority.

3.2.5    If a TGA audit is required, the GMP Reviewer applies for this via the TGA’s online system,
         TGA eBusiness Services, using the GMP Section’s account details for login purposes.
         Complete a Certification Application. This initiates the TGA audit process.

3.2.6    The GMP Reviewer should immediately notify the applicant that the request has been lodged
         with the TGA, and request that they must submit resumes and site master files direct to the
         TGA within 14 days to:
             Office of Manufacturing Quality
             Therapeutic Goods Administration
             PO Box 100
             Woden ACT 2606

3.2.7    The TGA will notify both the applicant and the APVMA of the proposed audit date. If
         notification has not been received in an acceptable time frame, contact the TGA to enquire
         about this. When notification is received, provide the TGA auditor with pre-audit information
         about the manufacturing site.

3.3 Audit Review and Issue of Certificate

3.3.1    The TGA will submit the audit report and other documentation to the APVMA and notify the
         APVMA when the audit is closed.

3.3.2    When the audit is closed, evaluate the audit to confirm that this meets APVMA requirements
         for certification. If a satisfactory TGA audit had occurred prior to the application, this must be
         evaluated to confirm that it meets APVMA requirements for certification.

3.3.3    Prepare a Briefing Note to be signed by the Delegate (Manager, GMP Section). This should
         include an assessment of the audit, and reasons for recommending the issue of a Certificate of
         GMP Compliance. Prepare a Certificate of GMP Compliance of a Manufacturer in the

 KP80_W11                   Issue Date: 2/10/09               Version: 6               Page 2 of 4
            approved format, located in folder O:\DEVPROJ\GMP\MRA_EU. Print this on the
            watermarked A4 paper for MRA certificates. Submit both of these documents to the delegate
            for approval and signing.

3.3.4       When the certificate is signed, place the Briefing Note and copy of the certificate on relevant
            files. Mail the Certificate of GMP Compliance with covering letter to the applicant. Enter
            details in the Record List of MRA Certificates, located in folder
            O:\DEVPROJ\GMP\MRA_EU, and the audit tracking database.

3.3.5       If a decision is made not to issue the certificate, notify the applicant by mail of the reasons for
            this decision and explain appeal provisions.

3.4     Timeframes

In the MRA, the Parties have undertaken to issue certificates expeditiously (see Clause 1 of Section III
of the MRA Sectoral Annex). The time taken should not normally exceed:
        •     30 calendar days on receipt of the request where an audit is not required; and
        •     60 calendar days on receipt of the request where an audit is required.

The GMP Reviewer should liaise with the TGA on time frames, and if delays are anticipated, advise
the applicant of any likely delay. Time taken by manufacturers to close non-conformances found at
audit should not be included in these time frames.


4.0     RESPONSIBILITY

The GMP Reviewer or GMP Officer is responsible for all steps in this process.


5.0     DELEGATIONS

The APVMA delegate (Manager, GMP Section) is responsible for reviewing the recommendations
and granting/denying issue of the Certificate of GMP Compliance of a Manufacturer.


6.0     WORK INSTRUCTIONS, FORMS AND TEMPLATES
        KP80-W6        Review and Closure of GMP Audits.
        KP80-F39 Request for a Certificate of GMP Compliance of a Manufacturer issued under the
                 provisions of the MRA between Australia and the European Community (EC).


7.0     REFERENCES

        •     The APVMA’s Agricultural and Veterinary Chemicals Instrument No. 1 (Manufacturing
              Principles) 2007
              http://www.comlaw.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/all/search/9154
              3638201448DECA2572BF00832534?OpenDocument

        •     The Australian Code of Good Manufacturing Practice for Veterinary Chemical Products.
              Australian Code of Good Manufacturing Practice for Veterinary Chemical Products
        •      Mutual Recognition Agreement on Conformity Assessment Between the European
               Community and Australia.

 KP80_W11                      Issue Date: 2/10/09               Version: 6                Page 3 of 4
      •     Mutual Recognition Agreement on Conformity Assessment Between the European Free
            trade Association and Australia.
      •     Australian Code of GMP for Medicinal Products (TGA).
      •     PIC/S Explanatory Notes for Industry on the Preparation of a Site Master File
            (Pharmaceutical Inspection Convention/Co-operation Scheme publication, Document PH
            4/93, April 1993).


8.0   DEFINITIONS

      MRA        Mutual Recognition Agreement of Conformity Assessment
      EU         European Union
      EFTA       European Free Trade Association
      GMP        Good Manufacturing Practice
      TGA        Therapeutic Goods Administration
      EMEA       European Medicines Agency




 KP80_W11                 Issue Date: 2/10/09          Version: 6           Page 4 of 4

				
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