Revision of relevant PIC/S Guidance Documents in 2014

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

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.

The document  is divided into two main 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 second document is the Annex 14 "Manufacture of medicinal products derived from human blood or plasma".

Medicinal products derived from human blood or plasma (and their active substances which are used as starting materials) must comply with the principles and guidelines of Good Manufacturing Practice as well as the relevant marketing authorisation. They are considered to be biological medicinal products and the starting materials include biological substances, such as cells or fluids (including blood or plasma) of human origin.

Therefore, following the scope of this Annex:

• The provisions of this Annex apply to medicinal products derived from human blood or plasma, fractionated in or imported into the country. The Annex applies also to the starting material (e.g. human plasma) for these products. In line with national legislation the requirements may apply also for stable derivatives of human blood or human plasma (e.g. Albumin) incorporated into medical devices.
• This Annex defines specific Good Manufacturing Practices (GMP) requirements for collection, processing, storage and transport of human plasma used for fractionation and for the manufacture of medicinal products derived from human blood or plasma.
• The Annex addresses specific provisions for when starting material is imported from other countries and for contract fractionation programs for other countries.
• The Annex does not apply to blood components intended for transfusion.

The complete Annexes can be found at the PIC/S Website.