GMP for Active Ingredient Manufacturers: Change Control
Form Template
The GMP for Active Ingredient Manufacturers: Change Control
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mobile app is part of a GMP Program. Changes to manufacturing processes for A.I.s can affect the quality of medicinal products manufactured from such changed A.I.s. A.I. producers should therefore have a system in place to evaluate and approve changes and notify, when appropriate, not only the authorities, but also the user. The amount of information to be forwarded to the authorities and/or the user, if any, will depend on the significance of the change. The app covers Change control procedures, and Implementation of changes. Dispatch is perfect for Project and Case Managers.
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