Guidance on the GMP clearance of overseas medicine manufacturers

More documents

Recommendations

Info

GMP Clearance for Overseas Manufacturers, 17 th Edition Version 1.0, May 2011 Therapeutic Goods Administration • translated documents must be accompanied by a signed and dated statement, by the certified translator, stating that it is a true and accurate translation of the original document; • documents must be the most recent and reflect current manufacturing conditions and practices and dated (expired/superseded documentation cannot be used); • documents must provide sufficient information to cover the scope of dosages for which clearance is sought; and • documented evidence must be unambiguous, clearly demonstrating that the overseas manufacturer operates with an adequate level of GMP Compliance (ambiguous material will be disregarded). All documents are to be submitted electronically and are not required to be certified as original copies unless requested by the TGA. Certification of a document may be requested if for example, there was concern over the validity of the supplied documents. The TGA can request certified copies of original documents at any time. Certified copies must be legible and authenticated as true copies by any one of the following: • an official of the regulatory agency of a country that is a party to an MRA or is a Memorandum of Understanding (MOU) partner; • an Australian embassy or consulate office; or • a Justice of the Peace, Public Notary or a lawyer, solicitor or accountant (include details of the relevant practice certificate or licence number). The following is an example of a declaration that should appear on the front page of the document being certified: Declaration of Authenticity As a ………. for the state of (xxxxx), (country xxxxx), I declare that the attached copy of the document issued by (xxxxx) (certificate) is a true and accurate copy of an original certificate presented to me for review. Signed (xxxxx) Date (xxxxx) GMP Certificates GMP Certificates provided with an application must be: • current, and whenever possible, should be not more than two years since the date of the last inspection in order to avoid a short expiry date on a GMP Clearance; • for the products, APIs, steps of manufacture and/or dosage forms requested in the GMP Clearance application; and • clear in identifying the expiry date and the name of the person authorised to issue the certificate and be duly signed and dated. • For MRA-based applications, GMP Certificates must also be: • issued by a regulator of an overseas country that is a party to the MRA; and • relate to a manufacturing site located within the borders of that country. Where the sponsor has been unable to obtain the GMP certification issued by the MRA country, the sponsor may request that the TGA attempt to obtain evidence from the relevant MRA regulator. An additional fee is payable for this service. Page 18 of 39
Manufacturer’s declarations for Active Pharmaceutical Ingredients GMP Clearance for Overseas Manufacturers, 17 th Edition Version 1.0, May 2011 Therapeutic Goods Administration Sometimes various types of APIs are produced using similar manufacturing processes and the same quality system. A GMP Certificate for a site issued by another overseas regulatory agency may only list one or some of the APIs which are of interest to the country inspecting the site. The TGA therefore permits a sponsor to submit a declaration consisting of a dated and signed letter from the manufacturer that the API for which a clearance is sought is manufactured by the same process, in the same plant and under the same quality system as those specified on a GMP Certificate. The form for a manufacturer’s declaration is in Appendix D (Manufacturer’s Declaration for APIs). If such a declaration cannot be submitted in these circumstances, a TGA on-site audit may be required. Documents for a TGA on-site audit A TGA on-site audit of an overseas manufacturer will be required where: • the evidence supplied is inadequate to support clearance for supply to the Australian market, or • where there has not been a recent inspection by a recognised competent regulatory agency covering the scope of the GMP Clearance application, or • where GMP compliance was rated as unacceptable by another regulatory agency. After receiving an application, but prior to confirming an audit, the TGA will require the Site Master File (SMF). The sponsor should ensure the manufacturer supplies a current, up-to-date SMF. The SMF provides an overview of the manufacturer, its manufacturing activities and its quality system. The SMF is necessary to allow effective planning of the audit. <strong>Guidance</strong> for preparing a SMF can be found in PIC/S document PE 008, Explanatory Notes for Industry on the preparation of a Site Master File that is available at: http://www.tga.gov.au/industry/manuf-pics-site-master-file.htm. Sponsors may submit other documents from the manufacturer, such as a Plant/Equipment File or a Quality Manual, which individually or collectively provides the same details. Where the TGA will be undertaking an initial audit in a non-English speaking country, English translations/versions of the following will be required: • Site Master File • Validation Master Plan. • Deviation/Out of Specification Procedures. • Release for Supply Procedures. • Product Quality Reviews (as requested). For any subsequent TGA audit, a list of products (with batch numbers) manufactured over the last 2 years for Australia will also be required. The TGA lead auditor may request other documents prior to commencing an audit overseas. Sharing of documentary evidence between sponsors and manufacturers To reduce the regulatory burden on industry and avoid unnecessary re-assessments of clearance applications, the TGA has established Manufacturer Master Files in a limited number of cases. By employing a Manufacturer Master File an overseas manufacturer may be invited to submit all necessary documentation for GMP Compliance Verification (of a site) on behalf of multiple Page 19 of 39
Page 1 and 2: Australian Regulatory Guidelines Go
Page 3 and 4: Version history GMP Clearance for O
Page 5 and 6: GMP Clearance for Overseas Manufact
Page 13 and 14: - A new GMP Clearance application m
Page 17: Evidence List D Contract testing la
Page 23 and 24: 3. Maintenance of a Clearance In or
Page 27 and 28: Medicinal products MRA MRA regulato
Page 29 and 30: Appendix B - International agreemen
Page 37 and 38: What they are Appendix H - Manufact
Page 39: Therapeutic Goods Administration PO

Guidance on the GMP clearance of overseas medicine manufacturers

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?