cgmp--currentgoodmanufacturingpractice(中英文对照版).docxVIP

A A ?总则 Subpart A-General Provisions 211. 1范围 § 211.1 Scope (a) The regulations in this part contain the minimum curre nt good manu facturi ng practice for preparati on of drug products for administration to humans or animals. The current good manufacturing practice (b) 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 huma n use, shall be con sidered to supplement, not supersede the regulations in this part uni ess the regulati ons explicitly provide otherwise. In the eve nt it is impossible to comply with applicable regulati ons 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 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。 product in question shall supersede the regulation in this part. c) Pending con siderati on of a proposed exempti on, 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 defi niti on of drugs by virtue of their inten ded use. Therefore, un til further no tice, regulati ons under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determ ining whether these OTC drug products that are also foods are manufactured, processed, packed, or held un der curre nt good manu facturi ng practice. § 211.3 Definitions. （c）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 The definitions set forth in §210.3 of th