EU GMP Annex 13 - Investigational Medicinal Products

What it says

Investigational medicinal products used in clinical trials must be manufactured under GMP principles adapted for their specific context, including special considerations for blinding, randomisation, comparator sourcing, batch documentation despite typically smaller batch sizes, and Qualified Person certification specific to the investigational product.

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

What it means in practice

• Investigational products are held to GMP expectations adapted for a different context than commercial manufacturing, smaller batch sizes, evolving specifications during development, and the need to maintain blinding, rather than a relaxed standard.
• Blinding and randomisation controls, where applicable, add a layer of process control specific to clinical trial material that has no direct equivalent in commercial batch production.
• Comparator product sourcing and, where necessary, re-packaging or re-labeling of a comparator product to maintain blinding carries its own documented control expectations under this annex.

What inspectors look for

• Whether blinding and randomisation controls are documented and verifiably maintained throughout manufacturing, packaging and distribution of the investigational product.
• Whether batch documentation, despite smaller batch sizes typical of clinical trial material, remains as complete and traceable as commercial batch documentation.
• Whether comparator product handling, including any re-packaging or re-labeling, is controlled with the same rigor as the investigational product itself.

Related regulations