ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 10.1-10.2: Store materials under recorded appropriate conditions with segregated quarantine, rejected, returned and recalled stock, distribute only quality-released product, control transport and keep distribution records that allow recall

What does 10.1-10.2 require?

Storage facilities should hold all materials under suitable conditions, such as controlled temperature and humidity where needed, with records kept where conditions are critical. Unless another system prevents unintended or unauthorised use, quarantined, rejected, returned or recalled materials should have separate storage until their future use is decided. APIs and intermediates should be released to third parties only after quality unit release, though they may move under quarantine to another unit within the company when the quality unit authorises it with suitable controls and records. Transport should not harm quality, special transport or storage conditions should appear on the label, and the manufacturer should make sure the transport contractor knows and follows them. A system should allow the distribution of each batch to be readily traced to permit recall.