How to set analytical specification for combination products?
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Answer / Monika Sirohi
Setting analytical specifications for combination products involves establishing test methods, acceptable quality limits (AQLs), and requirements for each component as well as the final product. This includes identifying the active and inactive ingredients, excipients, and degradation products if applicable. Additionally, appropriate test methods should be validated to ensure they can accurately determine the identity, purity, strength, and quality of the individual components and the final product. This may involve collaborating with regulatory bodies such as the FDA or EMA for guidance.
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