ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Sections 7 to 10: materials management, production and in-process controls, packaging and labelling, storage and distribution – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 9.4: Run packaging and labelling to prevent mix-ups, label containers with the required identity, batch, storage, manufacturer and dating information, line-clear before use, check labelled packs and apply tamper-evident seals

What does 9.4 require?

Documented procedures should make sure the right packaging and labels are used, and labelling operations should be physically or spatially separated from other products to prevent mix-ups. Container labels should show the name or code, batch number and, where critical, storage conditions; for material leaving the manufacturer's material management system, also the manufacturer's name and address, quantity, special transport conditions and any legal requirements, with any expiry date on both the label and the certificate of analysis, or the retest date on the label and/or certificate. Packaging and labelling areas should be inspected just before use to confirm all unneeded materials are gone, with the check recorded. Packed and labelled containers should be examined for correct labels as part of the operation and the results recorded. Containers that leave the manufacturer's control should carry a seal so that a broken or missing seal alerts the recipient that contents may have been altered.

Maintained by Gerard Blokdyk

Other controls in Sections 7 to 10: materials management, production and in-process controls, packaging and labelling, storage and distribution – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Query this from an agent

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