美国FDACGMP英汉对照版

1 美国FDA CGMP 英汉对照版 Subpart A-General Provisions § 211.1 Scope a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. b) 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 regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part. c) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice. § 211.3 Definitions. The definitions set forth in §210.3 of this chapter apply in this part. A．总则 211．1 范围 （a） 本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。 ...