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 6.3: Record receipt, testing, use and disposition of raw materials, intermediates, labels and packaging materials, and keep master labels for comparison

What does 6.3 require?

Records should include for every batch in every delivery of raw materials, intermediates, labels and packaging: the manufacturer's name, identity and quantity, the supplier's name, the supplier's control or other identification number if known, the receipt number given and the date of receipt; results of tests or examinations and the conclusions drawn; records tracing use; evidence that API labels and packaging were examined and checked against specification; and the final decision on rejected materials. Approved master labels should be kept for comparison with issued labels.

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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