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This assistance will not be intended to determine registration and/or submitting demands or modify pharmacopoeial demands. This assistance doesn't impact the power of the responsible regulatory company to determine precise registration/submitting demands relating to APIs in the context of promoting/production authorizations or drug applications. Al

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It's because airlock rooms commonly do not have adequate surplus supply air to keep up the demanded tension differential required to prevent reverse stream because of air turbulence all through door operation. Although a room is provided by using a rapid-response (1 to three seconds) VAV air provide system to offer added surplus air, It is far from

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