ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 7.2: Inspect each incoming container, quarantine materials until released, prevent wrong discharge into existing stock, assure tanker cleanliness and give every lot a distinctive code and status

What does 7.2 require?

When a delivery arrives and before it is accepted, every container or group of containers should be checked visually for correct labelling (including the link between supplier and in-house names), damage, broken seals and signs of tampering or contamination, and kept in quarantine until it has been sampled, examined or tested as needed and released. Before incoming materials join existing stocks such as solvents or silo contents, they should be confirmed correct, tested where needed and released, with procedures preventing wrong discharge. Bulk deliveries in non-dedicated tankers need assurance against cross-contamination, for example a cleaning certificate, trace impurity testing or supplier audit. Large storage containers and their manifolds and lines should be identified. Each container or batch should be given its own code, batch or receipt number used to record its disposition, and a system should show each batch's status.