GMP: Revision of relevant PIC/S Guidance Documents in 2014
Amongst the guidance documents of the European Union and of the US authorities, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) published the revisions of two relevant guidance documents on blood, plasma or biological medicinal products in January 2014. They became effective on 1 March 2014. The first document is the Revised Annex 2 of the PIC/S GMP Guide \"Manufacture of biological medicinal substances and products for human use\". This annex provides guidance on the full range of medicinal substances and products defined as biological.