PIC/S (Pharmaceutical Inspection Co-operation Scheme) publishes its two revised GMP guidance documents

On Jan 2014, PIC/S (Pharmaceutical Inspection Co-operation Scheme) published two revised GMP annex guidance document namely Annex 2 and Annex 14. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of Good manufacturing Practices (GMP). Under Annex 14 GMP guide for “Manufacture of Medicinal Products derived from Human blood or Plasma” is covered and Annex 2 of the PIC/S GMP Guide covers "Manufacture of biological medicinal substances and products for human use". Both were effective from 1 March 2014.

Annex 14 provides guidance on Manufacture of Medicinal Products derived from Human blood or Plasma and is divided into following sections:


  • Scope
  • Principles
  • Quality Management
  • Traceability and Post Collection Measures
  • Premises and equipment
  • Manufacturing
  • Quality Control
  • Release of intermediate and finished products
  • Retention of plasma pool samples
  • Disposal of waste

Annex 2 provides guidance on the full range of medicinal substances and products defined as biological.

This annex is divided into two main parts:

  1. a) 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.
  1. b) Part B contains further guidance on selected types of biological medicinal substances and products.

Ultimately the fruitful outcome lies in the scope of the Annex which applies to stable derivatives of Human blood or Human plasma incorporated into Medical devices but don’t apply to blood components intended for blood transfusion.