EU GDP for Active Substances (2015/C 95/01) - Good Distribution Practice of Active Substances

What it says

Active substances distributed for use in medicinal product manufacture must be handled under good distribution practice requirements specific to active substances, covering storage, transportation, documentation and traceability, recognizing that active substances carry different handling and contamination risks than finished medicinal products.

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

What it means in practice

• These guidelines apply specifically to active substance distribution, distinct from the finished product distribution requirements in the broader EU GDP Guidelines, since bulk active substances often have different storage, packaging and handling needs than packaged finished product.
• Active substance distributors sit in the supply chain between API manufacturers, often applying ICH Q7 or EU GMP Part II, and finished product manufacturers, making their distribution practices a potential point where quality or identity issues can be introduced undetected.
• Traceability expectations here connect closely to anti-falsification goals, since active substances are a documented target for supply chain fraud given their high value and the difficulty of visually verifying their identity.

What inspectors look for

• Whether active substance storage and transportation conditions are appropriate to the specific substance's stability requirements, not treated identically to finished product handling.
• Whether active substance supplier and distributor qualification specifically addresses distribution-stage risks, not just manufacturing-stage quality.
• Whether documentation accompanying active substance shipments supports full traceability back to the original manufacturing site.

Related regulations