GMP clearance for overseas manufacturers
16 May 2011
Good Manufacturing Practice (GMP) clearance is required for all medicines (unless exempt) supplied in Australia. The TGA has produced guidance for sponsors who rely on overseas manufacturers for any part of their production process.
The guidance has two main purposes:
- to provide adequate information about what is an acceptable form of evidence to confirm GMP compliance by overseas manufacturers
- to offer practical guidance on how to submit such evidence to the TGA for assessment.
The guidance does not provide a definitive list of acceptable or unacceptable forms of evidence.
Guidance on the GMP clearance of overseas medicine manufacturers
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- Guidance on the GMP clearance of overseas medicine manufacturers, 17th edition, May 2011 (pdf,545kb)
- Guidance on the GMP clearance of overseas medicine manufacturers, 17th edition, May 2011 (Microsoft Word,5.41Mb)
Content last updated: Monday, 16 May 2011
Content last reviewed: Monday, 29 April 2013
Web page last updated: Wednesday, 1 May 2013