Many of these concepts are applicable to BPCs to assure that such BPCs are manufacturered in accordance with CGMPs as required by the Act under Section 501 (a)(2)(B).

• 这其中的许多概念是适用于原料药的以确认这些原料药的制造是根据CGMP的要求的，如501（a）（2）（B）章中所要求的。