美国cGMP 中英文对照
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PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
210部分 有关于生产、加工、包装和药品的储存的现行GMP；一般准则
Sec. Status of current good manufacturing
practice regulations. cGMP的法规地位。
(a) The regulations set forth in this part and in
parts 211 through 226 of this chapter contain
the minimum current good manufacturing
practice for methods to be used in, and the
facilities or controls to be used for, the
manufacture, processing, packing, or holding
of a drug to assure that such drug meets the
requirements of the act as to safety, and has
the identity and strength and meets the quality
and purity characteristics that it purports or is
represented to possess.
(a)在本部分及本章第211－226部分中所陈述的法规，为现行GMP最低要求，适用于药品制造、加工、包装或贮存中所采用的方法及所使用的设施或控制手段，以保证该药品符合《联邦食品、药品及化妆品法案》（以下简称法案）对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。
(b) The failure to comply with any regulation
set forth in this part and in parts 211 through
226 of this chapter in the manufacture,
processing, packing, or holding of a drug shall
render such drug to be adulterated under
section 501(a) (2)(B) of the act and such drug,
as well as the person who is responsible for
the failure to comply, shall be subject to
regulatory action.
(b)凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时导致该事故发生的负责人应受相应的法规的制裁。
(c) Owners and operators of establishments
engaged in the recovery, donor screening,
testing (including donor testing), processing,
storage, labeling, packaging, or distribution of
human cells, tissues, and cellular and
tissue-based products (HCT/Ps), as defined in
(d) of this chapter, that are drugs (subject to
review under an application submitted under
section 505 of the act or under a biological
product license application under section 351
of the Public Health Service Act), are subject
to the donor-eligibility and applicable current
good tissue practice procedures set forth in
part 1271 subparts C and D of this chapter, in
addition to the regulations in this part and in
parts 211 through 226 of this chapter. Failure
to comply with any applicable regulation set
forth in this part, in parts 211 through 226 of (c)人类细胞、组织和细胞组织底物产品（HCT/Ps），根据本章§(d)的定义属药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核），从事该类药品回收、捐献者筛选、检验（包括捐献者检验）、加工、贮藏、贴标、包装或销售企业的所有者和经营者，除受本部分法规及21CFR第211－226部分约束外，还应受本章第1271部分的C子部分和D子部分陈述的捐献者合格性和适用的《现行良好组织操作规程》的约束。在药品制造、加工、包装或贮存过程中，如存在不符合本部分及21CFR第211—226部分、21CFR第1271部分的C子部分或21CFR第1271部分的D子部分中任何法规的情况，依据《法案》第501节
(a)(2)(B)，将该HCT/P视为劣药，并且对该HCT/P及事故责任人采取相应监管措施。 this chapter, in part 1271 subpart C of this
chapter, or in part 1271 subpart D of this
chapter with respect to the manufacture,
processing, packing or holding of a drug,
renders an HCT/P adulterated under section
501(a)(2)(B) of the act. Such HCT/P, as well
as the person who is responsible for the failure
to comply, is subject to regulatory action.
Sec. Applicability of current good
manufacturing practice regulations. cGMP法规的适用性
(a) The regulations in this part and in parts 211
through 226 of this chapter as they may pertain
to a drug; in parts 600 through 680 of this
chapter as they may pertain to a biological
product for human use; and in part 1271 of this
chapter as they are applicable to a human cell,
tissue, or cellular or tissue-based product
(HCT/P) that is a drug (subject to review under
an application submitted under section 505 of
the act or under a biological product license
application under section 351 of the Public
Health Service Act); shall be considered to
supplement, not supersede, each other, unless
the regulations explicitly provide otherwise. In
the event of a conflict between applicable
regulations in this part and in other parts of this
chapter, the regulation specifically applicable
to the drug product in question shall supersede
the more general.
(a)本部分及21CFR211-226适用于普通药品，21CFR 600-680适用于人用生物制品，21CFR
1271部分适用于人类的细胞、组织或是细胞组织底物产品(HCT/P) 类药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核），它们之间应该是相互补充而不是相互取代，法规另有明确规定除外。在适用本部分法规和21CFR其它部分法规发生冲突的情况下，特别法规应替代普通法规适用于所涉及的药品。
(b) If a person engages in only some
operations subject to the regulations in this
part, in parts 211 through 226 of this chapter,
in parts 600 through 680 of this chapter, and in
part 1271 of this chapter, and not in others,
that person need only comply with those
regulations applicable to the operations in
which he or she is engaged.
(b)如果一个人的具体操作仅涉及到21CFR中的本部分，211到226部分，600到680部分和1271部分，而不参与到其他部分中，这个人仅仅需要遵守他/她所涉及的相关操作的规范。
(c) An investigational drug for use in a phase 1
study, as described in (a) of this chapter, is
