PIC/S: Publication of Revised GMP Annex 1
The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close co-operation with the European Commission (EC) and the World Health Organization (WHO).
Annex 1 was first published in 1971 based on a PIC/S recommendation to ensure the sterility of medicinal products for the benefits of patients. It has undergone a number of partial revisions since its publication. This is, however, the first full revision aiming at restructuring this Annex, adding clarity to the requirements on the sterile manufacturing of medicinal products and introducing the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes.
Source:
PIC/S News: Publication of revised PIC/S Annex 1
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
