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This advice just isn't intended to define registration and/or submitting demands or modify pharmacopoeial requirements. This advice would not impact the flexibility of your accountable regulatory agency to establish particular registration/submitting demands regarding APIs in the context of promoting/production authorizations or drug apps. All comm

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Mencantumkan batas waktu pelaksanaan perbaikan dan PIC atau penanggungjawab untuk masing-masing tahap perbaikan. Conversely, there may be various ways to solve Every trigger.  The basis lead to could be the initiating, most basic explanation for an issue that may or may not cause a series of will cause or other challenges.  Removing the foundati

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