PIC/S GMP Guideline - Revised Annex 2 for biological Substances and Products adopted

Recommendation

6/7 February 2024

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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.

For further details see PIC/S GMP Guide (PE 009-11).