Guidance on the GMP clearance of overseas medicine manufacturers

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Appendix I – Target Timeframes GMP Clearance for Overseas Manufacturers, 17 th Edition Version 1.0, May 2011 Therapeutic Goods Administration The following targets for dealing with GMP Clearance applications enable orderly processing and assessment. The TGA is usually able to meet these targets unless the level of compliance demonstrated in the evidence supplied is low or there are delays in receiving any additional documentation as requested. The relevant period starts when the TGA has received the application, supporting data and fees. Application Type Outcomes (and major task outputs) Target Timeframe Overseas Clearance - based on GMP certificate from an MRA country < 15 working days Overseas Clearance - compliance verification (lower risk products) < 30 working days Overseas Clearance - compliance verification (higher risk products) < 90 working days Certificate of GMP Compliance - based on TGA Initial Audit < 6 months Certificate of GMP Compliance - based on TGA Re-audit < 6 months Issue of Certificate of GMP or notarised copy of certificate < 15 working days • All timeframes are subject to the co-operation of manufacturers and sponsors, and in some cases, international regulatory authorities. Certification(s) will be withheld until satisfactory resolution of any deficiencies or non-conformities identified. • The TGA’s processing time excludes any delay where a sponsor has requested the TGA to obtain the GMP Certificate. • MRA agreements provide each party with 30 calendar days to supply a GMP Certificate, or 60 days if an inspection is required. On-Site Audits Where a TGA on-site audit is required, the TGA will initiate an application for a separate GMP Clearance for each of the sponsors paying for the TGA audit. GMP Clearances will be issued to each relevant sponsor after the audit has been completed and acceptable compliance has been found. Overseas TGA on-site audits involve considerable lead-time in planning to ensure efficient audit visits. The usual lead time for an initial overseas on-site audit or a renewal of a GMP Certification for a site that was previously audited by the TGA is 6 months from the date of an effective GMP Certification application. Subject to the time required to receive and assess any deficiencies at an audit, a GMP certificate will usually be processed within 15 working days of despatch of the audit close-out letter. The timeframes provided are correct at the time of publication but are subject to review. Modifications to these timeframes will be updated as required. Page 38 of 39
Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605 www.tga.gov.au Reference/Publication #
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 and 18: Evidence List D Contract testing la
Page 19 and 20: Manufacturer’s declarations for A
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: What they are Appendix H - Manufact

Guidance on the GMP clearance of overseas medicine manufacturers

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