21 CFR § 212.61 - What must I do to ensure the stability of my PET drug products through expiry?

prev next
§ 212.61 What must I do to ensure the stability of my PET drug products through expiry?

(a) Stability testing program. You must establish, follow, and maintain a written testing program to assess the stability characteristics of your PET drug products. The test methods must be reliable, meaningful, and specific. The samples tested for stability must be representative of the lot or batch from which they were obtained and must be stored under suitable conditions.

(b) Storage conditions and expiration dates. The results of such stability testing must be documented and used in determining appropriate storage conditions and expiration dates and times for each PET drug product you produce.