9/10 November 2021
End of January, the PIC/S published the current revision of their GMP Guide (PE 009-11). The revised Guide will become effective on 1 March 2014. Amongst other parts, the Annex 2 "Manufacture of biological medicinal substances and products for human use" was revised. Like the Annex 2 of the EU GMP Guide, the PIC/S Annex is divided in two parts:
The Annex 2 will give guidance and recommendation for the different types of biological products:
For specific products or starting materials there are further legislations as, for example, for blood or blood components. Thus, the Annex should be read in conjunction with the necessary national legislation.
For further details see PIC/S GMP Guide (PE 009-11).