ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 7.4-7.5: Store materials to prevent degradation and contamination, off the floor, oldest first, with rejected stock quarantined, and re-evaluate materials after prolonged storage or exposure

What does 7.4-7.5 require?

Materials should be handled and stored so they do not degrade, become contaminated or cross-contaminate others. Materials in fibre drums, bags or boxes should be kept off the floor and spaced for cleaning and inspection where appropriate. Storage conditions and duration should not harm quality, and stock should normally be rotated so the oldest is used first. Some materials in suitable containers may be stored outdoors if labels stay legible and containers are cleaned before opening. Rejected materials should be identified and kept under a quarantine system that prevents unauthorised use. Materials should be re-evaluated where appropriate to confirm they are still fit for use, for example after long storage or after heat or humidity exposure.