ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 9.1-9.2: Control receipt, testing and release of packaging and labelling materials, reject non-conforming ones, and use clean, non-reactive containers that protect the product

What does 9.1-9.2 require?

Written procedures should cover receipt, identification, quarantine, sampling, examination or testing, release and handling of label stock and packaging, which should meet their specifications; non-conforming items should be rejected. Each shipment of labels and packaging should be recorded with its receipt, examination or testing and acceptance or rejection. Containers should protect intermediates and APIs against deterioration or contamination during transport and recommended storage, be clean and sanitised where the product requires, and not be reactive, additive or absorptive in a way that pushes quality outside limits. Reused containers should be cleaned under documented procedures with all earlier labels removed or defaced.