ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Section 6: documentation and records – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 6.2: Keep equipment use, cleaning, sanitisation, sterilisation and maintenance logs that identify the date, product, batch and person

What does 6.2 require?

Records of use, cleaning, sanitisation or sterilisation and maintenance of major equipment should show the date, time where relevant, product and batch processed, and who did the cleaning and maintenance. For equipment dedicated to one intermediate or API, separate equipment records are not needed if batches follow in a traceable sequence, and the cleaning, maintenance and use records may sit in the batch record or apart from it.

Maintained by Gerard Blokdyk

Other controls in Section 6: documentation and records – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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