ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 18.2: Restrict access to cell banks, store them to keep viability and prevent contamination, record vial use and storage and monitor suitability

What does 18.2 require?

Only authorised people should have access to cell banks. Cell banks should be stored in conditions chosen to keep the cells viable and free of contamination, records of vial use and storage conditions kept, and banks periodically monitored for suitability where appropriate. ICH Q5D gives fuller guidance on cell banking.