gmp | ARQon

Aug 141 min read

PIC/S: Revised PIC/S GMP Guide on Manufacture of Sterile Products (Lyophilization - w.e.f 25 August 2024)

Annex 1 of the PIC/S Good Manufacturing Practise (GMP) Guide on the manufacture of sterile products has been revised and published. The...

Jun 191 min read

Australia: TGA Adopts PIC/S Guide to GMP Version 16: Manufacturing Principles for Medicines, APIs & Sunscreens (w.e.f 3 September 2024)

On 3 June 2024, the Therapeutic Goods Administration (TGA) amended its Therapeutic Goods (Manufacturing Principles) Determination...

May 71 min read

Brazil: ANVISA Announces to Extend B-GMP Certificates for MDSAP-Certified Medical Device Manufacturers (w.e.f 1 April 2024)

On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing...