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This steerage is not meant to outline registration and/or filing prerequisites or modify pharmacopoeial specifications. This guidance will not affect the flexibility of the responsible regulatory company to determine certain registration/filing needs with regards to APIs within the context of marketing/producing authorizations or drug applications.
Information needs to be created, manually or electronically, in the course of manufacture that display that all the actions necessary by the outlined methods and instructions were in fact taken and that the amount and high quality on the food items or drug was as expected. Deviations should be investigated and documented.(b) Legitimate in-process r
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