21 CFR 212.61 - What must I do to ensure the stability of my PET drug products through expiry?
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(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.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.