ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Sections 14 to 17: rejection and re-use, complaints and recalls, contract manufacturers, agents, brokers, traders and distributors – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 14.4: Recover reactants, intermediates, APIs and solvents only under approved, controlled and monitored procedures with documented use and proven suitability

What does 14.4 require?

Recovering reactants, intermediates or the API (for example from mother liquors or filtrates) is acceptable if approved recovery procedures exist and recovered materials meet specifications fit for their use. Solvents may be recovered for reuse in the same process or another if recovery is controlled and monitored so solvents meet standards before reuse or mixing with other approved materials. Fresh and recovered solvents and reagents may be combined if testing shows them suitable for every process in which they may be used. Any use of recovered solvents, mother liquors or other reclaimed materials should be documented.

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Other controls in Sections 14 to 17: rejection and re-use, complaints and recalls, contract manufacturers, agents, brokers, traders and distributors – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.