Good Manufacturing Practices Archives

Good Manufacturing Practices, mutual recognition agreement, TGA (Australia)

TGA updates on GMP clearance for an overseas manufacturing site

This post the following TGA updates on GMP clearance for an overseas manufacturing site: 1. GMP clearance sponsor information dashboard and guidance updates This update concerns sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site…

12 December 2023

Good Manufacturing Practices, Manufacturer's Authorisations, TGA (Australia)

TGA updates guidance on aspects of Australian manufacturing licences and overseas GMP certification

The TGA, Australia has updated several updated guidance documents on aspects of Australian manufacturing licences and overseas GMP certification. 1) Applying for a manufacturing licence for an Australian manufacturing site This updated step-by-step, 47 page guide (version 2.2, Dec 2021) with…

1 December 2021