It is Never Too Late to Document Your Cold Chain Process Validation Approach
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Documentation strategy for your cold chain management validation practices has evolved over the last several years. The FDA and other regulatory agencies are requesting more and more specific information in the filing to confirm the impact to drug product during transport, and the effect transportation hazards have on shelf life. An overall strategy of providing minimal documentation in the Biologic License Application (BLA) has evolved to provide a more complete and comprehensive review of the...
