PIC/S revises Annex 14 for Medicinal Products derived from Human Blood or Plasma

Recommendation

6/7 February 2024

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On 31 January, the PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S) published the revised Annex 14 of the PIC/S GMP Guide (PE 009-11). This Annex will apply to medicinal products derived from human blood or plasma, fractionated in or imported into the country as well as to starting materials for these products. The document provides specific guidance on GMP practices related to the collection, processing, storage and transport.

Furthermore the Annex can also be used for stable derivatives of human blood or human plasma (e.g. Albumin) incorporated into medical devices. In this case, it should be used in line with the national legislation. Additionally, the Annex 14 addresses specific provisions for when starting material is imported from other countries and for contract fractionation programs for other countries.

The revised document includes the following parts:

• Glossary
• 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

For the complete document please look at the PIC/S GMP Guide (PE 009-11).