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GMP clearance for overseas manufacturers
3. Maintenance of a Clearance
In order to maintain a clearance, sponsors are required to:
- Advise the TGA of any significant changes to the manufacturing site, QMS, products, product range. Significant changes are changes that could potentially affect GMP compliance.11
- Maintain evidence of GMP compliance of all overseas manufacturing sites used, and notify the TGA immediately of any changes in circumstances or regulatory compliance of the overseas manufacturer.
- Please refer to the Responsibilities of Australian Sponsors of Overseas Manufacturers on pages 7-8.
The expiry of GMP Clearances will depend on the type of product(s) and/or APIs manufactured and the outcome of the assessment (MRA or Compliance Verification).
The period of GMP Clearance given to a manufacturing site is normally a maximum of the certification expiry plus 6 months; or three years plus 6 months from the date of inspection. (The additional 6 month period facilitates the completion and assessment of re-inspections/audits.) The expiry period may be reduced based on a risk assessment or other justification.
Where a GMP Clearance has expired, or is about to expire, a new GMP Clearance application must be submitted for assessment.
The TGA may also require information from a sponsor under Section 31 of the Act to obtain evidence of GMP compliance for a manufacturing site outside of Australia.
11. The TGA is introducing a Periodic Manufacturer Update form to assist sponsors in meeting this requirement.