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:
Part A contains supplementary guidance on the manufacture of biological medicinal substances and products, from control over seed lots and cell banks or starting material through to finishing activities and testing.
Part B contains further guidance on selected types of biological medicinal substances and products.
The Annex 2 will give guidance and recommendation for the different types of biological products:
Animal Sourced Products
Allergen Products
Animal Immunosera Products
Vaccines
Recombinant Products
Monoclonal Antibodies
Transgenic Animal Products
Transgenic Plant Products
Gene Therapies
Somatic and Xenogenic Cell Therapies and Tissue Engineering
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.