CGMP英文.doc

Subpart A-General Provisions § 211.1 Scope The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. The current good manufacturing practice regulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regu