EU GMP Annex 14 - Manufacture of Products Derived from Human Blood or Plasma

What it says

Manufacture of medicinal products derived from human blood or plasma requires specific controls addressing donor selection and testing, traceability from donation through to finished product, viral safety validation given the biological source material, and plasma pool documentation connecting finished batches back to the individual donations comprising them.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Traceability requirements under this annex are exceptionally stringent, requiring the ability to trace a finished batch back through the plasma pool to the individual donations that contributed to it, given the unique biological origin and associated safety considerations of this product category.
• Viral safety validation, demonstrating the manufacturing process adequately inactivates or removes potential viral contaminants, is a specific and heavily scrutinised control category given the historical safety concerns associated with blood-derived products.
• Donor selection and testing standards, governed by separate blood donation regulations, must be integrated with the manufacturing quality system to ensure only appropriately screened source material enters the manufacturing process.

What inspectors look for

• Whether traceability genuinely connects finished batches back through plasma pools to individual donations, with documentation supporting this chain being complete and retrievable.
• Whether viral safety validation data adequately supports the specific manufacturing process's ability to inactivate or remove relevant viral contaminants.
• Whether donor testing and selection standards are verified as met before plasma is accepted into the manufacturing process, not merely assumed based on supplier assurance.

Related regulations