ICH Q7 - Good Manufacturing Practice for Active Pharmaceutical Ingredients

What it says

Active pharmaceutical ingredient manufacturers must apply GMP principles across the full manufacturing process, with the degree of control increasing as the process progresses from early intermediate steps toward the final API, and specific requirements for critical process steps, reprocessing, and change control.

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

What it means in practice

• ICH Q7 applies a graduated GMP expectation - early synthesis steps carry lighter documentation and control expectations than steps closer to the final API, reflecting proportionate risk rather than uniform rigor throughout.
• Reprocessing, reworking an intermediate or API that does not conform to standards, is permitted but requires its own documented justification and evaluation, not treated as routine production.
• Critical process steps and critical process parameters must be identified and specifically controlled and monitored, distinguishing them from steps where broader operating ranges are acceptable.

What inspectors look for

• Whether the site's own risk-based determination of which process steps are critical is documented and defensible, not simply assumed.
• Whether reprocessing and reworking activities are distinguished from one another and each carries its own documented justification.
• Whether change control scales its rigor to how close the changed step is to the final API, consistent with the graduated control principle.

Related regulations