EU GMP Part II - Basic Requirements for Active Substances Used as Starting Materials

What it says

Active substances used as starting materials in the manufacture of medicinal products must be manufactured in accordance with GMP principles specific to active substance manufacturing, covering quality management, personnel, buildings, equipment, documentation, materials management, production and laboratory controls, closely aligned with ICH Q7.

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

What it means in practice

• EU GMP Part II is the EU's active substance counterpart to the finished dosage form requirements in Part I, recognizing that API manufacturing has different risk profiles and controls than finished product manufacturing.
• Because Part II is closely harmonized with ICH Q7, a site already compliant with ICH Q7 principles will generally align well with Part II, but Part II remains the operative EU regulatory text for EU inspections.
• The transition point between where API manufacturing ends and finished dosage form manufacturing begins, and which GMP part applies, is itself a point of regulatory judgment that sites must document clearly.

What inspectors look for

• Whether the API manufacturing site's quality system correctly applies Part II requirements rather than the finished dosage form requirements of Part I, or an inconsistent blend of both.
• Whether critical process parameters and quality attributes for the active substance are defined and controlled with the same rigor expected under ICH Q7.
• Whether the boundary between API manufacturing steps and finished product manufacturing steps is clearly defined and consistently applied across batch documentation.

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