Guidance on the GMP clearance of overseas medicine manufacturers

GMP Clearance for Overseas Manufacturers, 17 th Edition
Version 1.0, May 2011
Therapeutic Goods Administration
Appendix D - Manufacturer’s declaration for APIs
There is no set format for the “manufacturer declaration”. The document must:
• be in English, or presented with a certified English translation
• carry the company letterhead (or other identifier of the manufacturer); and
• be authorised by an officer of that company at the senior management level.
The letter should also provide the tracking numbers of the relevant Clearance application(s)
submitted by the sponsor.
A manufacturer’s declaration must include the following:
1. Confirmation that the API(s) included in the application (include names of APIs) are
manufactured at the nominated facility under the same quality system and in the same facility
(buildings) as the APIs stated in the audit report provided to the TGA.
2. Details of starting materials (include names) for the API(s) included in the application, and
confirmation that all steps of manufacture (for each API) are carried out at the nominated site.
If any steps of manufacture are carried out at another site or company, please provide details.
3. Details of whether any previous audits by any other regulatory agencies have covered the API(s)
included in the application. If so, a copy of the audit report should be provided.
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