ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 17.7-17.8: Distributors and repackers record complaints and recalls, review them with the original manufacturer where warranted, keep the manufacturer's responses, and handle and document returns

What does 17.7-17.8 require?

Every agent, broker, trader, distributor, repacker and relabeller should keep complaint and recall records as in section 15 for every complaint and recall they learn of. Where warranted, they should go over the complaint with the original maker to decide on further action with other customers or the regulator, and the cause should be investigated and documented by the appropriate party. Where a complaint goes to the original manufacturer, their record should include any response received, with date and content. Returns should be handled as in section 14.52, with documentation of returned material kept.