Implementing Successful Stability Testing Operations

Once a candidate drug reaches use in humans, all stability storage and testing must be
conducted according to current good manufacturing practices  (CGMPs). The regulatory mandate for stability testing in the United States is contained in 21 CFR Part 211 Section 166, which states that There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include…. Although 21 CFR addresses stability data treatment and reporting for expiration dating, it says almost nothing about how to ensure control within the stability storage operation or how to design stability protocols. There are many ways to run a stability operation in a GMPcompliant manner, but the bottom line is to have written procedures and protocols with documented evidence that they are followed.

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