CGMP--CurrentGoodManufacturingPractice(中英文对照版).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 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. 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 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）。 在本章里的这些针对药品的现行GMP条例和本章600～680部分的所有针对人用生物制品的现行GMP条例，除非明确另有说明外，应认为是对本部分条例的补充，而不是代替。本章其他部分或本章600～680g各部分均可适用的条例，前部分的条例可以代替本部分条例。 在考虑经提议的，发表在 1978年9月29日联邦注册表（FR）上一项免除时，若产品及其所有成分是以人用物品形式作一般销售和消费，且这些产品根据其预期用途，亦可列入药品的范围，则不应对这些非处方药（OTC）实施本部分条例，直至进一步的通知为止。本章110部分和113至119部分的条例用于鉴别这些亦是食品的OTC药品是否按照GMP的要求生产、加工、包装＆贮存。 211．3定义 本章211．3中的定义使用于本部分。 good manufact