Timely and accurate evaluation of identity, strength, quality, purity and potency are key to successfully managing stability and release programs.
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Timely and accurate evaluation of identity, strength, quality, purity and potency are key to successfully managing stability and release programs. IPEC’s new stability testing guide takes into account the full supply chain’s storage conditions. The author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies. A database coupled to a statistical analysis program is an effective means of defining a control space, determining process capability of components, establishing specifications for components and drug product and potentially correlating leachable levels to component extractable levels. Statistical analysis and modeling can be used to assess correlations, provide real-time process capability, and provide predictive stability plots. |
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