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GMP clearance for overseas manufacturers

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16 May 2011

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.

Clearance expiry

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.


Footnotes

11. The TGA is introducing a Periodic Manufacturer Update form to assist sponsors in meeting this requirement.

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