galeno美国cGMP-中英文对照

2021年1月19日发(作者：奶子)

PART 210
CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PROCESSING, PACKING, OR
HOLDING OF DRUGS; GENERAL


Sec. 210.1 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.
在本部分及本章第
211
－
226
部分中所陈述的法规，为现行良好制造规 范的最低要求，
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< br>证该药品符合《法案》对安全性的要求，
具有其声称的或表明拥有的同一性和药物规格，
并符合质量及纯度特征。



(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.
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本章

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
50 1 (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 1271.3(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 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.

人类细胞、
组织 和细胞组织底物产品
（
HCT/Ps
）
，
根据本章
§
1271.3(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，除受本部分法规及本章第
211
－
226
部分约束外，还应受本 章第
1271
部分的
C
子部和
D
子部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 合本部分及本章第
211
—
226
部分、
本章第
1271< br>部分的
C
子部或本章第
1271
部
分的
D
子 部中任何法规的情况，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。


Sec. 210.2 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.
本部分及本章
211
—
226
适用于普通药品，本章
600
—
680
适用于人用生物制品，本章
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)

）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）的法规，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本章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.
如果一个人参与到了
21CFR
中相关法规的一些具体操作中，
21CFR
的
211
到
226
部分，
600
到
680
部 分和
1271
部分，而不参与到其他部分的，这个人仅仅需要遵守他
/
她所涉
及的相关操作的相关规范。

(c) An investigational drug for use in a phase 1 study, as described in 312.21(a) of this
chapter, is subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B).
The production of such drug is exempt from compliance with the regulations in part 211
of this chapter. However, this exemption does not apply to an investigational drug for
use in a phase 1 study once the investigational drug has been made available for use

by or for the sponsor in a phase 2 or phase 3 study, as described in 312.21(b) and (c)
of this chapter, or the drug has been lawfully marketed. If the investigational drug has
been made available in a phase 2 or phase 3 study or the drug has been lawfully
marketed, the drug for use in the phase 1 study must comply with part 211.
在本章

312.21(a)
部分描述的要调查研究第一阶段研究的药品要服从在
21 U.S.C.
351(a)(2)(B)
中的陈述的法定的要求。这种药物的生产
免 予
21CFR
第
211
部分法规的要
求
。然而，一旦这个要 调研的新药可以被申请者应用到第二，三阶段的研究中，如本章
中
312.21(b) and (c)
描述的那样，或是药品已经合法上市，那前面所述的不一致并不适
用于一个要用到的调研 新药的第一阶段的研究。如果要调研的新药已经在第二阶段和第
三阶段中应用或是药品已经合法上市了， 那么药品的第一阶段的研究必须遵守
211
部分
的要求。

[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008]
[
《联邦公报》
69
卷第
2982 8
页，
2004
年
5
月
25
日，
联邦公报 》
71
卷第
2462
页修订，
2006
年
1月
17
日
]

Sec. 210.3 Definitions.
定义


(a) The definitions and interpretations contained in section 201 of the act shall be
applicable to such terms when used in this part and in parts 211 through 226 of this
chapter.
在联邦食品、药品及化妆品法
201
部分中包含的定义和解释、说明适用于本章

211
—
226
部分中的术语。

(b) The following definitions of terms apply to this part and to parts 211 through 226 of this
chapter.
在联邦食品、
药品及化妆品法
201
部分中包含的定义和解释、
说明 同样适用于本章
211
—
226
部分中的术语

(1)
Act
means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301
et
seq.
).
法案
(Act)
指联邦食品、药品及化妆品法，修订版
(21 U.S.C

301 et seq.)
。

(2)
Batch
means a specific quantity of a drug or other material that is intended to have
uniform character and quality, within specified limits, and is produced according to a single
manufacturing order during the same cycle of manufacture.
批
(Batch)
指在规定限度内， 按照某一生产指令在同一生产周期内生产出来的，具有同一性
质和质量的一定数量的药品或其它物料。< br>

(3)
Component
means any ingredient intended for use in the manufacture of a drug
product, including those that may not appear in such drug product.
组分
(Component)
指用于药品生产过程中的所有成份，包括那些未在药品中出现的成份。

(4)
Drug product
means a finished dosage form, for example, tablet, capsule, solution, etc.,
that contains an active drug ingredient generally, but not necessarily, in association with
inactive ingredients. The term also includes a finished dosage form that does not contain
an active ingredient but is intended to be used as a placebo.
药品
(Drug Product)
指成品制剂
(
如：片剂、胶囊剂、口服液等
)
，通 常含有一种活性成份并
伴有非活性成份
(
但不是必需的
)
。本术语也 包括不含有活性成份但作为安慰剂使用的成品制
剂。

(5)
Fiber
means any particulate contaminant with a length at least three times greater than
its width.
纤维
(Fiber)
指 长度大于其宽度的
3
倍的任何微粒状污染物。

(6)
Nonfiber releasing filter
means any filter, which after appropriate pretreatment such as
washing or flushing, will not release fibers into the component or drug product that is being
filtered.
无纤维脱落的过滤器
(Non-fiber- releasing filter)
指任何经过适当的预处理
(
如清洗或冲洗
)
后，不会将纤维脱落到已过滤的组分或药品中的所有过滤器。

(7)
Active ingredient
means any component that is intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of
disease, or to affect the structure or any function of the body of man or other animals. The
term includes those components that may undergo chemical change in the manufacture of
the drug product and be present in the drug product in a modified form intended to furnish
the specified activity or effect.
活性成份
(Active Ingredient)
是指任何用于保 证药物活性或其他在疾病的诊断、
治愈、
缓解、
治疗或预防中起直接作用，
或 影响人或其他动物身体结构或功能的组分。
本术语包括那些在
药品制造中发生化学变化并为了发 挥其特定的活性或疗效而以一种修饰的形式存在于药品
中的组份。

(8)
Inactive ingredient
means any component other than an
active ingredient.


非活性成份
(Inactive ingredient)

指不同于
“
活性成份
”
的其他任何组分。



















(9)
In- process material
means any material fabricated, compounded, blended, or derived

by chemical reaction that is produced for, and used in, the preparation of the drug product.
中间产品
(In-process material)
是指所有经制备、复合、混合 或经由化学反应得到的用于药
品生产或制备的物料。

(10)
Lot
means a batch, or a specific identified portion of a batch, having uniform character
and quality within specified limits; or, in the case of a drug product produced by continuous
process, it is a specific identified amount produced in a unit of time or quantity in a manner
that assures its having uniform character and quality within specified limits.
批（
lot
）
指一批或是一批中特定的均一部分，在指定的 范围内具有相同的性质和质量；或
者若为由连续的生产过程制造出的药品，
“
批
”
指在单位时间或单位数量生产出的特定的、均
一的部分，并且确保该部分在指定的范围内具 有均一性质与质量。

(11)
Lot number, control number, or batch number
means any distinctive combination of
letters, numbers, or symbols, or any combination of them, from which the complete history
of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug
product or other material can be determined.
批号
(Lot number, control number
，
batch number)
指由字母、数字、符号 或他们的组合
组成，由此可确定某批药品或物料的生产、加工、包装、贮存或销售的情况。

(12)
Manufacture, processing, packing, or holding of a drug product
includes packaging
and labeling operations, testing, and quality control of drug products.
药品的生产、
加工、
包装或贮存
(Manufacture, processing, packing, or holding of a drug
product)
包括药品的包装和标签操作、检验、质量控制。

(13) The term
medicated feed
means any Type B or Type C medicated feed as defined in
558.3 of this chapter. The feed contains one or more drugs as defined in section 201(g) of
the act. The manufacture of medicated feeds is subject to the requirements of part 225 of
this chapter.
药用物料
(medicated
feed)
指在本章
558.3< br>中定义的
B
型和
C
型药用物料。该物料含有联
邦食品、
药品及化妆品法
201(g)
部分中定义的一种或一种以上的药物，
药用物料的生产 应符
合
21CFR 225
部分中的要求。

(14) The term
medicated premix
means a Type A medicated article as defined in 558.3 of
this chapter. The article contains one or more drugs as defined in section 201(g) of the act.
The manufacture of medicated premixes is subject to the requirements of part 226 of this
chapter.
药用预混合料
(medicated premix)
指本章

558.3
中定义的
A
型药用物质。该预混合料含有

联邦 食品、
药品及化妆品法
201(g)
部分中定义的一种或一种以上的药物。
药 用预混合料生产
应符合
21CFR 226
部分中的要求

(15)
Quality control unit
means any person or organizational element designated by the
firm to be responsible for the duties relating to quality control.
质量控制部门
(Quality
control
unit)
指由企业任命负责质量控制相关责任的任何人员或组
织机构

(16)
Strength
means:
(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or
unit dose/volume basis), and/or
(ii) The potency, that is, the therapeutic activity of the drug product as indicated by
appropriate laboratory tests or by adequately developed and controlled clinical data
(expressed, for example, in terms of units by reference to a standard).
规格（
Strength
）

(
Ⅰ
)

原料药的浓度
(
如：以重量
/
重量、重量
/
体积、 单位剂量
/
体积为基础
)
；和
/(
或
)
(
Ⅱ
)

活性
(
效价
)
即根据适当的实验室检测或足够的临床研究可靠数据而得出的药品治疗
活性
(
例如 可表达为相对当于多少单位的标准物质
)
。


(17)
Theoretical yield
means the quantity that would be produced at any appropriate phase
of
manufacture,
processing,
or
packing
of
a
particular
drug
product,
based
upon
the
quantity
of
components
to
be
used,
in
the
absence
of
any
loss
or
error
in
actual
production.
理论产量
(Theoretical
yield)
指在生产、加工或包装某 种药品的任一适当阶段中，并且基于
所使用的组分的数量在实际生产中无任何损失或错误的情况下，应能 生产的数量。

(18)
Actual yield
means the quantity that is actually produced at any appropriate phase of
manufacture, processing, or packing of a particular drug product.
实际产量
(Actual
yield)
指某种药品在生产、加工、包装的任 一适当的阶段实际生产出的数
量。

(19)
Percentage of theoretical yield
means the ratio of the actual yield (at any appropriate
phase of manufacture, processing, or packing of a particular drug product) to the
theoretical yield (at the same phase), stated as a percentage.
理论收率
(Percentage of theoretical yield)

指制造、加工或包装某种药品的任一适当阶段
的实际产量与该阶段理论产量的比率，以百分数表 示。



(20)
Acceptance criteria
means the product specifications and acceptance/rejection
criteria, such as acceptable quality level and unacceptable quality level, with an
associated sampling plan, that are necessary for making a decision to accept or reject a lot
or batch (or any other convenient subgroups of manufactured units).
接受标准
(Acceptance criteria)
指与取样检验方法相联系的 产品技术规定和接受
/
拒绝标
准，诸如可接受的质量水平及不可接受的质量水平，这是 对一批或一整批（或其它产出单元
中方便表示的小集合）做出接受或拒绝的必要依据。

(21)
Representative sample
means a sample that consists of a number of units that are
drawn based on rational criteria such as random sampling and intended to assure that the
sample accurately portrays the material being sampled.
代表性样品
(Representative sample)
指 一个样品包含若干单位
（元）
按合理的标准抽取
（如
随机取样法）
， 以能保证样品准确描绘被取样品的物料。

(22) Gang-printed labeling means labeling derived from a sheet of material on which more
than one item of labeling is printed.
多项印刷贴标
(Gang-printed labeling)

指从物料表所演变来的贴标，上面印刷有一个以上
的条目。

[
《联 邦公报》
43
卷第
45076
页，
1978
年
9< br>月
29
日，
《联邦公报》
51
卷第
7389
页修订，
1986
年
3
月
3
日；
《联邦公报》58
卷第
41353
页，
1993
年
8
月3
日；
《联邦公报》
73
卷第
51931
页，
2008
年
9
月
8
日
]

[43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353,
Aug. 3, 1993; 73 FR 51931, Sept. 8, 2008]



PART 211
CURRENT GOOD MANUFACTURING PRACTICE FOR
FINISHED PHARMACEUTICALS



Subpart A--General Provisions

总则


§
211.1
- Scope.
范围


§
211.3
- Definitions.
定义

Subpart B--Organization and Personnel

组织机构及人员


§
211.22
- Responsibilities of quality control unit.
质量控制部门的职责


§
211.25
- Personnel qualifications.
人员资质


§
211.28
- Personnel responsibilities.
人员职责


§
211.34
- Consultants.
顾问

Subpart C--Buildings and Facilities

建筑和设备


§
211.42
- Design and construction features.
设计与建造特征


§
211.44
- Lighting.
照明


§
211.46
- Ventilation, air filtration, air heating and cooling.
通风、空气过滤、空气加热
与冷却


§
211.48
- Plumbing.
管件


§
211.50
- Sewage and refuse.
污水和废料


§
211.52
- Washing and toilet facilities.
洗涤和盥洗设备



§
211.56
- Sanitation.
卫生


§
211.58
- Maintenance.
保养

Subpart D--Equipment

设备


§
211.63
- Equipment design, size, and location.
设备的设计、尺寸及位置


§
211.65
- Equipment construction.
设备的建造


§
211.67
- Equipment cleaning and maintenance.
设备的清洁和维护


§
211.68
- Automatic, mechanical, and electronic equipment.
自动化设备、机械化设备
和电子设备


§
211.72
- Filters.
过滤器

Subpart E--Control of Components and Drug Product Containers and Closures
成
分、药品容器和密封件控制


§
211.80
- General requirements.
总体要求


§
211.82
- Receipt and storage of untested components, drug product containers, and
closures.
未检验的成份、药品容器和密封件的接收与贮存


§
211.84
- Testing and approval or rejection of components, drug product containers,
and closures.
成份、药品容器和封口物品的试验、批准或拒收


§
211.86
- Use of approved components, drug product containers, and closures.
批准的
组分，药物的容器和密封件的应用




§
211.87
- Retesting of approved components, drug product containers, and closures.

获准的组分、药品容器和密封件的复检
.

§
211.89
- Rejected components, drug product containers, and closures.
拒收的成份、

药品容器和密封件


§
211.94
- Drug product containers and closures.
药品容器和密封件

Subpart F--Production and Process Controls

生产和加工控制


§
211.100
- Written procedures; deviations.
成文的规程、偏差


§
211.101
- Charge-in of components.
成分的进料


§
211.103
- Calculation of yield.
产量计算


§
211.105
- Equipment identification.
设备鉴别


§
211.110
- Sampling and testing of in-process materials and drug products.
中间体和
药品的取样与检验


§
211.111
- Time limitations on production.
生产时间限制


§
211.113
- Control of microbiological contamination.
微生物污染的控制


§
211.115
- Reprocessing.
返工

Subpart G--Packaging and Labeling Control

包装和标签控制


§
211.122
- Materials examination and usage criteria.
材料的检查和使用标准


§
211.125
- Labeling issuance.
标签的发放


§
211.130
- Packaging and labeling operations.
包装和标签操作


§
211.132
- Tamper-evident packaging requirements for over- the-counter (OTC) human
drug products.
人用非处方药（
OTC
）保险包装的要求


§
211.134
- Drug product inspection.
药品检查


§
211.137
- Expiration dating.
有效期

Subpart H-- Holding and Distribution

贮存和销售


§
211.142
- Warehousing procedures.
入库程序


§
211.150
- Distribution procedures.
销售程序

Subpart I--Laboratory Controls

实验室控制


§
211.160
- General requirements.
总体要求


§
211.165
- Testing and release for distribution.
销售的检验与发放


§
211.166
- Stability testing.
稳定性实验


§
211.167
- Special testing requirements.
特别检验要求


§
211.170
- Reserve samples.
样品保存


§
211.173
- Laboratory animals.
实验动物


§
211.176
- Penicillin contamination.
青霉素污染

Subpart J-- Records and Reports

记录和报告


§
211.180
- General requirements.
总体要求


§
211.182
- Equipment cleaning and use log.
设备清洁和使用记录


§
211.184
- Component, drug product container, closure, and labeling records.
成份、
药
品容器、密封件及标签记录


§
211.186
- Master production and control records.
主要生产和控制的记录


§
211.188
- Batch production and control records.
批生产和控制记录


§
211.192
- Production record review.
产品记录复查


§
211.194
- Laboratory records.
实验记录


§
211.196
- Distribution records.
销售记录


§
211.198
- Complaint files.
投诉档案


Subpart K--Returned and Salvaged Drug Products

退回的药品和回收处理


§
211.204
- Returned drug products.
药品的退回


§
211.208
- Drug product salvaging.

药品的挽回处理



PART 211
CURRENT GOOD MANUFACTURING PRACTICE FOR
FINISHED PHARMACEUTICALS


Subpart A--General Provisions
一般性法则

Sec. 211.1 Scope.
范围


(a) The regulations in this part contain the minimum current good manufacturing
practice for preparation of drug products for administration to humans or animals.
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质量管理规范
（
GMP
）

(b) The current good manufacturing practice regulations in this chapter as they pertain
to drug products; in parts 600 through 680 of this chapter, as they pertain to drugs that
are also biological products for human use; and in part 1271 of this chapter, as they
are applicable to drugs that are also human cells, tissues, and cellular and
tissue-based products (HCT/Ps) and 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); supplement and do not
supersede the regulations in this part 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, or in parts 600 through 680 of this chapter, or in part 1271 of
this chapter, the regulation specifically applicable to the drug product in question shall
supersede the more general.
在本章里的这些针对药品的现行
GMP
条例和本章
600
至
800
的所有部分针对人用生物
制品的现行
GMP
条例，在本章的
1271
部分中，法规适用于人类 细胞，组织和细胞组织
为底物的产品（
HCT/Ps
）和一些药品，这些药品（服从联 邦法律
505
部分的关于提交
申请的复查部分或是公共卫生法的
351
部分的生物产品的申请许可）除非明确另有说明
者外，应认为是对本部分条例的补充，而是不代替。在 本章的这部分和其他部分，或者
是在本章的
600
到
680
的部分， 或是
1271
部分法规有发生冲突的情况下，则可用存在
争议药品的特定具体的法规来 替代一般性的。

(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.
在考虑经提议的，发表在
197 8
年
9
月
29
日联邦注册表（
FR
）上的一项免除 项是，若

产品及其所有成份是以人用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
列入药品的范围内，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< br>部分的条例用于鉴别这些
OTC
药品是否按照
GMP
的要求生产、加工 、包装和贮存。

[43 FR 45077, Sept. 29, 1978, as amended at 62 FR 66522, Dec. 19, 1997; 69 FR
29828, May 25, 2004]

Sec. 211.3 Definitions.

The definitions set forth in 210.3 of this chapter apply in this part.
本章
210?3
中解释的定义适用于本部分

Subpart B --Organization and Personnel
组织机构和人员

Sec. 211.22 Responsibilities of quality control unit.
质量控制部门的职责

(a) There shall be a quality control unit that shall have the responsibility and authority
to approve or reject all components, drug product containers, closures, in-process
materials, packaging material, labeling, and drug products, and the authority to review
production records to assure that no errors have occurred or, if errors have occurred,
that they have been fully investigated. The quality control unit shall be responsible for
approving or rejecting drug products manufactured, processed, packed, or held under
contract by another company.
本部门有批准和 拒收所有成份、药品包装容器、密封件、中间体、包装材料、标签及药
品的职责与权力。复查生产记录和 权力，保证不产生差错，或若发生差错，保证他们充
分调查这差错。本部门负责根据合同，批准或拒收由 其它公司生产、加工、包装或贮存
的药品。

(b) Adequate laboratory facilities for the testing and approval (or rejection) of
components, drug product containers, closures, packaging materials, in- process
materials, and drug products shall be available to the quality control unit.
质量控制部门要 可以获得足够的实验室检验设备用于批准（或拒收）各种成份、药品容
器、密封件、包装材料及中间体。

(c) The quality control unit shall have the responsibility for approving or rejecting all
procedures or specifications impacting on the identity, strength, quality, and purity of
the drug product.
本部门有批准或驳回影响药品的均一性、规格、质量和纯度的所有程序或 规格标准的职
责。


(d) The responsibilities and procedures applicable to the quality control unit shall be in
writing; such written procedures shall be followed.

适用于本部门的职责与程序，应成文字材料，并应遵循执行。

Sec. 211.25 Personnel qualifications.
人员资质

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug
product shall have education, training, and experience, or any combination thereof, to
enable that person to perform the assigned functions. Training shall be in the particular
operations that the employee performs and in current good manufacturing practice
(including the current good manufacturing practice regulations in this chapter and
written procedures required by these regulations) as they relate to the employee's
functions. Training in current good manufacturing practice shall be conducted by
qualified individuals on a continuing basis and with sufficient frequency to assure that
employees remain familiar with CGMP requirements applicable to them.
每位从事药品生产 、加工、包装或仓贮工作人员，应接受培训、教育及有实践经验，完
成委派的各项任务。培训是按照现行
GMP
（包括本章中的现行
GMP
条例和这些条例要
求的成文程序） 中涉及雇员的内容。邀请有资质的人员指导，并连续多次培训，保证雇
员熟悉现行
GMP
对他们的要求。

(b) Each person responsible for supervising the manufacture, processing, packing, or
holding of a drug product shall have the education, training, and experience, or any
combination thereof, to perform assigned functions in such a manner as to provide
assurance that the drug product has the safety, identity, strength, quality, and purity
that it purports or is represented to possess.
负责监督药品的生产、加工、包装或仓贮工作的每一个工作人员，应受教育、培训及有
经验，完 成委派的各项职务。以此作为提供药品具有安全性、均一性、规格、质量及纯
度的保证。

(c) There shall be an adequate number of qualified personnel to perform and supervise
the manufacture, processing, packing, or holding of each drug product.

有足够人数的合格人员进行和监督每种药品的生产、加工、包装或仓贮的。

Sec. 211.28 Personnel responsibilities.
人员职责

(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug
product shall wear clean clothing appropriate for the duties they perform. Protective
apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to
protect drug products from contamination.
从事药品生产、加工、包装或仓贮的人员，应穿着适合于其履行职责的清洁衣服。按需

要，头部、脸部、手部、臂部要戴上保护性的装置，防止药物受污染。

(b) Personnel shall practice good sanitation and health habits.
























人员要保持良好的个人卫生和健康。

(c) Only personnel authorized by supervisory personnel shall enter those areas of the
buildings and facilities designated as limited-access areas.
只有监督人员授权的人员可以进入限制区域的建筑物和设施。

(d) Any person shown at any time (either by medical examination or supervisory
observation) to have an apparent illness or open lesions that may adversely affect the
safety or quality of drug products shall be excluded from direct contact with
components, drug product containers, closures, in-process materials, and drug
products until the condition is corrected or determined by competent medical personnel
not to jeopardize the safety or quality of drug products. All personnel shall be instructed
to report to supervisory personnel any health conditions that may have an adverse
effect on drug products.
任何人，在任何时间
（无论是通过医学检查或是监管观察出）
，明显地表现出有可能影响
药品安全性和质量的疾病或开放性损伤，应避免接触各种成份、药品 容器、包装设备、
密封件、中间体和最终产品，直至状况改善或是相关权威的监督人员认为不会对药品安
全性和质量有危害。所有的人员都要被告知如果发生任何可能对药品产生不良影响的健
康状况， 都要向相关的监督人员报告。

Sec. 211.34 Consultants.
顾问



Consultants advising on the manufacture, processing, packing, or holding of drug
products shall have sufficient education, training, and experience, or any combination
thereof, to advise on the subject for which they are retained. Records shall be
maintained stating the name, address, and qualifications of any consultants and the
type of service they provide.
顾问应对药品生产、加工、包装或仓贮提出建议 ，他们要受过足够的教育、培训，且有
丰富的实践经验，来对他们在行的领域的问题提出意见。有关他们 的姓名、地址、任何
的顾问资格证明及服务形式等履历资料要保存。

Subpart C--Buildings and Facilities

Sec. 211.42 Design and construction features.
设计与建造特征

(a) Any building or buildings used in the manufacture, processing, packing, or holding
of a drug product shall be of suitable size, construction and location to facilitate
cleaning, maintenance, and proper operations.

任何用于某类药品生产、加工、包装或贮存的厂房或建筑群，大小要适宜，结构与位置
要使其易于清洁、保养、适合操作。

(b) Any such building shall have adequate space for the orderly placement of
equipment and materials to prevent mixups between different components, drug
product containers, closures, labeling, in- process materials, or drug products, and to
prevent contamination. The flow of components, drug product containers, closures,
labeling, in-process materials, and drug products through the building or buildings shall
be designed to prevent contamination.
建筑物有足够空间来有条理地安装设备和放置材料， 避免不同类的成份、药品容器、密
封件、标签、中间体或药品等相互混放，防止污染。通过厂房的上述物 料其流向在设计
时要防止污染。

(c) Operations shall be performed within specifically defined areas of adequate size.
There shall be separate or defined areas or such other control systems for the firm's
operations as are necessary to prevent contamination or mixups during the course of
the following procedures:
操作应在明确规定的、大小适 中的区域内进行。在下列公司的操作过程中，
操作要分开，
在特定的区域或其他控制系统中进行 ，这个对于防止污染或是混淆是必要的。

(1) Receipt, identification, storage, and withholding from use of components, drug
product containers, closures, and labeling, pending the appropriate sampling, testing,
or examination by the quality control unit before release for manufacturing or
packaging;
发放给生产或包装前，由质量控 制部门取样、检测和检查药品的成份、容器、密封件及
标签，监督接收、鉴别、贮存及拒收的过程。
(2) Holding rejected components, drug product containers, closures, and labeling
before disposition;
在处理前，拒收的成份、药品容器、密封件及标签的贮存过程；

(3) Storage of released components, drug product containers, closures, and labeling;



已发放的成份、药品容器、密封件及标签的贮存过程；

(4) Storage of in-process materials;















































中间体的贮存；

(5) Manufacturing and processing operations;






































生产与加工操作；

(6) Packaging and labeling operations;













































包装和贴标签操作；

(7) Quarantine storage before release of drug products;





























药品发放前的隔离贮存；

(8) Storage of drug products after release;









































发放后药品的贮存；

(9) Control and laboratory operations;













































控制室与实验室操作；

(10) Aseptic processing, which includes as appropriate:





























无菌操作及有关适当操作；

(i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable;








地板、墙壁和天花板平滑、坚硬、表面易清洁；

(ii) Temperature and humidity controls;












































温度与湿度控制；

(iii) An air supply filtered through high-efficiency particulate air filters under positive
pressure, regardless of whether flow is laminar or nonlaminar























空气经高效过滤器、在正压下过滤、层流或非层流均可；


(iv) A system for monitoring environmental conditions;































环境监测系统；

(v) A system for cleaning and disinfecting the room and equipment to produce aseptic
conditions;




































































创造无菌环境、房间和设备清洁、消毒系统；

(vi) A system for maintaining any equipment used to control the aseptic conditions.






控制无菌环境的设备维修系统；

(d) Operations relating to the manufacture, processing, and packing of penicillin shall
be performed in facilities separate from those used for other drug products for human
use.


青霉素生产、加工及包装设备与生产其他人用药品的设备分开；


[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]

Sec. 211.44 Lighting
照明
.

Adequate lighting shall be provided in all areas.
所有地区均须提供充足的照明

Sec. 211.46 Ventilation, air filtration, air heating and cooling.


通风、空气过滤、空气加热与冷却

(a) Adequate ventilation shall be provided.
提供足够的通风

(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity,
and temperature shall be provided when appropriate for the manufacture, processing,
packing, or holding of a drug product.














































提供足够能控制空气正压、微生物、灰尘、温度和湿度的设备，适应药品生产、加 工、
包装和贮存需要。

(c) Air filtration systems, including prefilters and particulate matter air filters, shall be
used when appropriate on air supplies to production areas. If air is recirculated to
production areas, measures shall be taken to control recirculation of dust from
production. In areas where air contamination occurs during production, there shall be
adequate exhaust systems or other systems adequate to control contaminants.









空气过滤系统 ，包括预过滤器和微粒物质空气过滤器是用来在合适情况过滤空气送至生
产区，如果空气是再循环到生产 区，应测量尘埃含量，控制从生产区带来的尘埃。在生
产区、生产中发生空气污染，应以排气系统或其他 系统充分抽出空气，控制污染。

(d) Air-handling systems for the manufacture, processing, and packing of penicillin
shall be completely separate from those for other drug products for human use.









青霉素生产、加工和包装的空气输送系统应与其他人用药品的空气输送系统完全分开。

Sec. 211.48 Plumbing.
管件

(a) Potable water shall be supplied under continuous positive pressure in a plumbing
system free of defects that could contribute contamination to any drug product. Potable
water shall meet the standards prescribed in the Environmental Protection Agency's
Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting
such standards shall not be permitted in the potable water system.




















在持续正压下 ，应对药品无污染的管道系统内供应饮用水，管道系统内应没有可能导致
药品污染的缺陷。
饮用 水应符合环境保护机构制订的
“
基本饮用水条例
”
标准
（
4 0CFR141
部分）
。不符合该标准的水，不许进入水系统。

(b) Drains shall be of adequate size and, where connected directly to a sewer, shall be
provided with an air break or other mechanical device to prevent back-siphonage.






排水设备应有足够的大小，可直接连接排水管及安装防止虹吸倒流的空 气破坏设备或其
他机械设备。

[43 FR 45077, Sept. 29, 1978, as amended at 48 FR 11426, Mar. 18, 1983]

Sec. 211.50 Sewage and refuse.
污水和废料

Sewage, trash, and other refuse in and from the building and immediate premises shall

be disposed of in a safe and sanitary manner.






































来自水厂和附近建筑物或在建筑内的污水、垃圾及其他废料，用安全、卫生的方法处理

Sec. 211.52 Washing and toilet facilities
洗涤和盥洗设备
.

Adequate washing facilities shall be provided, including hot and cold water, soap or
detergent, air driers or single-service towels, and clean toilet facilities easily accesible
to working areas.































































提供洗涤和盥洗设备，包括热、冷水、肥皂、清洁剂、空气干燥器、专 用毛巾和干净的
进入工作区域的厨卫设备。

Sec. 211.56 Sanitation.
卫生


(a) Any building used in the manufacture, processing, packing, or holding of a drug
product shall be maintained in a clean and sanitary condition, Any such building shall
be free of infestation by rodents, birds, insects, and other vermin (other than laboratory
animals). Trash and organic waste matter shall be held and disposed of in a timely and
sanitary manner.
































































所有用作药品生产、加工、包装及贮存的建筑应保持清洁、卫生的环境，这种建筑不受
啮齿动物、鸟类及其他害虫侵害扰（实验动物除外）
。垃圾和有机废料，及时以卫生的方
法控 制处理。

(b) There shall be written procedures assigning responsibility for sanitation and
describing in sufficient detail the cleaning schedules, methods, equipment, and
materials to be used in cleaning the buildings and facilities; such written procedures
shall be followed.










填写分配卫生清洁任务的详细的清洁项目、方法、设备、用于清洁厂房和设施的材 料的
一览表，这些内容要依照执行。

(c) There shall be written procedures for use of suitable rodenticides, insecticides,
fungicides, fumigating agents, and cleaning and sanitizing agents. Such written
procedures shall be designed to prevent the contamination of equipment, components,
drug product containers, closures, packaging, labeling materials, or drug products and
shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless
registered and used in accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 135).


填写适用的杀鼠剂、杀昆虫剂、杀真菌剂、熏蒸剂、 去垢剂和消毒剂一览表。这个文件
要设计成是防止这些物品对设备、成份、药品容器密封件、包装材料、 标签或药品污染。
除依据联邦杀虫剂、杀真菌剂及杀鼠剂法规（
7U.S.C135
） 已登记和使用的品种外，其
他的杀虫剂、杀真菌剂及杀鼠剂不能使用。

(d) Sanitation procedures shall apply to work performed by contractors or temporary

employees as well as work performed by full- time employees during the ordinary
course of operations.
卫生程序要在临时承包人和临时雇员的工作中应用，同时也要在全职工作的雇 员日常操
作中应用。

Sec. 211.58 Maintenance.
保养

Any building used in the manufacture, processing, packing, or holding of a drug
product shall be maintained in a good state of repair.
































任何用于药品生产、加工、包装或贮存的建筑应保持良好保养状态。

Subpart D--Equipment
设备

Sec. 211.63 Equipment design, size, and location.
设备的设计、尺寸及位置

Equipment used in the manufacture, processing, packing, or holding of a drug product
shall be of appropriate design, adequate size, and suitably located to facilitate
operations for its intended use and for its cleaning and maintenance.


















药品生产、加 工、包装或贮存的设备，设计合理，大小适当，布置合理，便于操作、清
洁和保养。

Sec. 211.65 Equipment construction.
设备制造

(a) Equipment shall be constructed so that surfaces that contact components,
in-process materials, or drug products shall not be reactive, additive, or absorptive so
as to alter the safety, identity, strength, quality, or purity of the drug product beyond the
official or other established requirements.










































设备的制造要使表面与各 种中间体材料或药品成品接触，
不产生反应、
添加和吸附作用。
保证在官方的和其他的 设立的要求中，药品的安全性、均一性、效价或含量、质量或纯
度不发生改变。

(b) Any substances required for operation, such as lubricants or coolants, shall not
come into contact with components, drug product containers, closures, in-process
materials, or drug products so as to alter the safety, identity, strength, quality, or purity
of the drug product beyond the official or other established requirements.














操作所需之物质，如润滑 剂、冷却剂等不能接触组分、药品成品的容器、封口物品、中
间体和药品，保证在官方的和其他的设立的 要求中，药品的安全性、均一性、效价或含
量、质量或纯度不发生改变。

Sec. 211.67 Equipment cleaning and maintenance.
设备清洁与保养

(a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the
nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent

malfunctions or contamination that would alter the safety, identity, strength, quality, or
purity of the drug product beyond the official or other established requirements.









相隔一定时间，对设备与工具进行清 洁、保养和消毒，防止出故障与污染，影响药品的
安全性、均一性、效价或含量、质量或纯度，超出了官 方的和其他的设立的要求。

(b) Written procedures shall be established and followed for cleaning and maintenance
of equipment, including utensils, used in the manufacture, processing, packing, or
holding of a drug product. These procedures shall include, but are not necessarily
limited to, the following:


























































制订并执行设备的清洁维护，包括在药品生产、加工包装或贮存设备的工具的清洁 和保
养的文字程序。这些程序包括，但不限于以下内容：

(1) Assignment of responsibility for cleaning and maintaining equipment;














分配清洁、保养任务

(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing
schedules;




































































保养和清洁细目一览表，包括清洁的日程；

(3) A description in sufficient detail of the methods, equipment, and materials used in
cleaning and maintenance operations, and the methods of disassembling and
reassembling equipment as necessary to assure proper cleaning and maintenance;





详细说明用于清洁 和保养的设备、物品和方法。拆卸和装配设备的方法必须保证适合清
洁和保养的要求；

(4) Removal or obliteration of previous batch identification;



























除去或擦去前批遗留物的鉴定；

(5) Protection of clean equipment from contamination prior to use;

已清除了污染的清洁设备的保护；

(6) Inspection of equipment for cleanliness immediately before use.



















使用前检查清洁的设备；

(c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as
specified in 211.180 and 211.182.

















































保留保养、清洁、消毒的记录。按
211?180
及
211?18 2
的说明检查。

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008]

Sec. 211.68 Automatic, mechanical, and electronic equipment.























自动化设备、机械化设备和电子设备

(a) Automatic, mechanical, or electronic equipment or other types of equipment,

including computers, or related systems that will perform a function satisfactorily, may
be used in the manufacture, processing, packing, and holding of a drug product. If
such equipment is so used, it shall be routinely calibrated, inspected, or checked
according to a written program designed to assure proper performance. Written
records of those calibration checks and inspections shall be maintained.















用于药品生产、加工、包装和贮存的自动化、机械化或电子包括计算机或其它类型 的设
备，如果使用了这样的仪器，要对设计成文的条款作标定、检查或核对，来保证其工作
性能 良好。保留检查、标定、核对等文字记录。

(b) Appropriate controls shall be exercised over computer or related systems to assure
that changes in master production and control records or other records are instituted
only by authorized personnel. Input to and output from the computer or related system
of formulas or other records or data shall be checked for accuracy. The degree and
frequency of input/output verification shall be based on the complexity and reliability of
the computer or related system. A backup file of data entered into the computer or
related system shall be maintained except where certain data, such as calculations
performed in connection with laboratory analysis, are eliminated by computerization or
other automated processes. In such instances a written record of the program shall be
maintained along with appropriate validation data. Hard copy or alternative systems,
such as duplicates, tapes, or microfilm, designed to assure that backup data are exact
and complete and that it is secure from alteration, inadvertent erasures, or loss shall be
maintained.


























对保障重要生产变化的计算机或有关系统进行适 当的控制来保证大生产过程中的变化。
操作记录或其他记录只能由权威的人员制订。向计算机或有关系统 输入或从中输出的各
种方案、其他记录或资料，应核查其准确性。输入或输出的验证的频率和程度要基于 计
算机系统和相关系统的复杂和可信度。输入计算机或有关系统内的档案资料，除与实验
室共同 分析计算的结果或其他自动程序可消除外，其他的应保留。在这种情况下，文字
记录与相应的证明资料一 起保存。事先设计好的硬件复制品或各选择系统，如复印件、
磁带或微型胶卷等，保证其备用资料的正确 、可靠及完整。出现资料改动、非人为消除
或遗失时，可以安全的保存下来。

(c) Such automated equipment used for performance of operations addressed by
211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements
included in those sections relating to the performance of an operation by one person
and checking by another person if such equipment is used in conformity with this
section, and one person checks that the equipment properly performed the operation.
在
211.101(c) or (d), 211.103, 211.182, or 2 11.188(b)(11)
中说明的用于操作的自动仪器
要满足要求。这些要求包含在一个特 定的章节中，
这个章节讲述了，一个人员操作执行，
另一个人员复核。如果这种仪器的应用和本 部分的要求一致，一个人员检查仪器操作的
适宜性。

[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995; 73 FR
51932, Sept. 8, 2008]


Sec. 211.72 Filters.
过滤器

Filters
for
liquid
filtration
used
in
the
manufacture,
processing,
or
packing
of
injectable
drug
products
intended
for
human
use
shall
not
release
fibers
into
such
products. Fiber-releasing filters may be used when it is not possible to manufacture
such
products
without
the
use
of
these
filters.
If
use
of
a
fiber-releasing
filter
is
necessary, an additional nonfiber-releasing filter having a maximum nominal pore size
rating
of
0.2
micron
(0.45
micron
if
the
manufacturing
conditions
so
dictate)
shall
subsequently be used to reduce the content of particles in the injectable drug product.
The use of an asbestos- containing filter is prohibited.

用于生产、加工的 液体过滤器或人用注射药品的包装材料不许释放出纤维的进入产品。
除非这种产品没有这种过滤器就不可 能生产，不在生产、加工中使用释放纤维的过滤器
或注射药品的包装材料。若必须使用一种能释放纤维素 的过滤器，最后应使用一非释放
纤维物、平均最大孔径为
0.22μm(
如实际生产条 件限制，可用
0.45μm)
的附加过滤器过
滤，降低注射剂内微粒量。含石棉的过滤 器是禁止使用的。

[73 FR 51932, Sept. 8, 2008]

Subpart E--Control of Components and Drug Product Containers and Closures






成分、药品容器和密封件控制

Sec. 211.80 General requirements.
总体要求

(a) There shall be written procedures describing in sufficient detail the receipt,
identification, storage, handling, sampling, testing, and approval or rejection of
components and drug product containers and closures; such written procedures shall
be followed.













有文字详细说 明成份、药品容器、密封件的签收、鉴定、贮存、处理、取样、检验和批
准或拒收程序，并遵循执行。< br>
(b) Components and drug product containers and closures shall at all times be handled
and stored in a manner to prevent contamination.



































成份、药品容器和密封件应一直在防止污染的环境下贮存和管理。

(c) Bagged or boxed components of drug product containers, or closures shall be
stored off the floor and suitably spaced to permit cleaning and inspection.














药品容器的包装袋或包装箱或密封件应离地面放置保持适当间隔，可以清洁和检查。

(d) Each container or grouping of containers for components or drug product
containers, or closures shall be identified with a distinctive code for each lot in each
shipment received. This code shall be used in recording the disposition of each lot.

Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or
rejected).










用明显的已接收的每装货量中的批号代码对成分、药品容器或密
封件加以鉴别。此代码用于记录 每批货的放置地方。对每批货的情况，如隔离、批准或
拒收等鉴别。

Sec. 211.82 Receipt and storage of untested components, drug product containers,
and closures.
未检验的成份、药品容器和密封件的接收与贮存

(a) Upon receipt and before acceptance, each container or grouping of containers of
components, drug product containers, and closures shall be examined visually for
appropriate labeling as to contents, container damage or broken seals, and
contamination.
接收时和验收前，对每个或编组的成份容器、药品容器和密封 件进行目
检，内容物、容器损坏或拆封和污染等情况作适当的标识。

(b) Components, drug product containers, and closures shall be stored under
quarantine until they have been tested or examined, whichever is appropriate, and
released. Storage within the area shall conform to the requirements of 211.80.










成份、药品容器各密封件应隔离贮存，直至经检验为止。合格，可发放。在符合
211?80< br>要求的区域中贮存。

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]

Sec. 211.84 Testing and approval or rejection of components, drug product containers,
and closures.

成份、药品容器和封口物品的试验、批准或拒收。

(a) Each lot of components, drug product containers, and closures shall be withheld
from use until the lot has been sampled, tested, or examined, as appropriate, and
released for use by the quality control unit.









































每批成份、药品容器和封口物品，在未经质量部门取样、检查合格前，不准使用。检验
合格后由质量控制部门发放使用。

(b) Representative samples of each shipment of each lot shall be collected for testing
or examination. The number of containers to be sampled, and the amount of material
to be taken from each container, shall be based upon appropriate criteria such as
statistical criteria for component variability, confidence levels, and degree of precision
desired, the past quality history of the supplier, and the quantity needed for analysis
and reserve where required by 211.170.











































收集每批的每一装货量的代表性样品，供检验用。内容数量和每一容器里物质的取 样量
是有适当的标准的，例如，成份的变异性统计学标准、可信限、要求的精密度、供应商
过去 的质量历史、
21?170
要求分析和留样所需的数量等。

(c) Samples shall be collected in accordance with the following procedures:













根据以下程序收集样品。

(1) The containers of components selected shall be cleaned when necessary in a
manner to prevent introduction of contaminants into the component.



















用可以避免污染物的适当的方法，在必要的时候清洁选出来的装载成份的容器。

(2) The containers shall be opened, sampled, and resealed in a manner designed to
prevent contamination of their contents and contamination of other components, drug
product containers, or closures.


















































打开容器，取样，重新封口，防止其内容物受污染和其他成分、药品容 器或密封件的污
染。

(3) Sterile equipment and aseptic sampling techniques shall be used when necessary.


必要时，要使用灭菌设备和无菌取样技术。

(4) If it is necessary to sample a component from the top, middle, and bottom of its
container, such sample subdivisions shall not be composited for testing.















如果需要从容器顶部、中部和底部的成分中取样，样品检测时不能混合。

(5) Sample containers shall be identified so that the following information can be
determined: name of the material sampled, the lot number, the container from which
the sample was taken, the date on which the sample was taken, and the name of the
person who collected the sample.

















































标记样品容器，来确定如下资料：被取样的材料名称、批号 、被取样的容器，取样日期
及样品收集人的名字等。

(6) Containers from which samples have been taken shall be marked to show that
samples have been removed from them.











































已取样的容器，应作标志，表示样品已取出。

(d) Samples shall be examined and tested as follows:
样品检验程序：

(1) At least one test shall be conducted to verify the identity of each component of a
drug product. Specific identity tests, if they exist, shall be used.























一个药品的每个成分，最少做一个特性用于鉴别的试验。如有专一特性实验就要采用。

(2) Each component shall be tested for conformity with all appropriate written
specifications for purity, strength, and quality. In lieu of such testing by the
manufacturer, a report of analysis may be accepted from the supplier of a component,
provided that at least one specific identity test is conducted on such component by the
manufacturer, and provided that the manufacturer establishes the reliability of the
supplier's analyses through appropriate validation of the supplier's test results at
appropriate intervals.














依照所有成文的规格标准，为了一致性检验每个成份的纯度、含量和质量。如果生产厂
家代替上 述试验并且生产厂家每个组分最少做了一个特性试验，一份关于这个试验的分

析报告要可以从 生产厂家处获得；一定时间，生产厂家定期验证提供的试验结果，证明
供应者的分析结果是正确的。
(3) Containers and closures shall be tested for conformity with all appropriate written
specifications. In lieu of such testing by the manufacturer, a certificate of testing may
be accepted from the supplier, provided that at least a visual identification is conducted
on such containers/closures by the manufacturer and provided that the manufacturer
establishes the reliability of the supplier's test results through appropriate validation of
the supplier's test results at appropriate intervals.



































依照成文规程，检验容器和密封件。如果对容器或密封件进行了目检，并且生产厂 商建
立的在何时的期间，建立了合适的验证结果，生产厂家代替上述试验要出相应的检验报
告， 对这些容器或封口物品，最少做一次目检。证明其试验结果是正确的。

(4) When appropriate, components shall be microscopically examined.
















必要时，用显微镜检测成分。

(5) Each lot of a component, drug product container, or closure that is liable to
contamination with filth, insect infestation, or other extraneous adulterant shall be
examined against established specifications for such contamination.


















每批易受污物、昆虫或其他外来杂物污染的某一成份、药品容器或密封 件，根据检验标
准，应对这些污染进行检验。

(6)
Each
lot
of
a
component,
drug
product
container,
or
closure
with
potential
for
microbiological contamination that is objectionable in view of its intended use shall be
subjected to microbiological tests before use.

每一组分的每一 批，药品的容器或密封件有可能被微生物污染的，这种污染对于要应用
的目的是有害的，就要在使用前进 行微生物检测实验。


(e)
Any
lot
of
components,
drug
product
containers,
or
closures
that
meets
the
appropriate written specifications of identity, strength, quality, and purity and related
tests under paragraph (d) of this section may be approved and released for use. Any
lot of such material that does not meet such specifications shall be rejected.
< br>任何批号的成份、药品容器或密封件，若符合已成文的均一性、规格、质量、纯度等的
规格标准和 本部分（
d
）的有关试验，可批准放行使用。任何批号的上述材料，不符合这
些规格， 应拒收。

[43 FR 45077, Sept. 29, 1978, as amended at 63 FR 14356, Mar. 25, 1998; 73 FR
51932, Sept. 8, 2008]

Sec. 211.86 Use of approved components, drug product containers, and closures.
批准的组分，药物的容器和密封件的应用


Components, drug product containers, and closures approved for use shall be rotated

so that the oldest approved stock is used first. Deviation from this requirement is
permitted if such deviation is temporary and appropriate.





























获准使用的成份、药品容器和密封件要轮流使用，先入库者先用。若产生的偏差是 暂时
的和正当的，这种偏差是容许的。

Sec. 211.87 Retesting of approved components, drug product containers, and closures

获准的组分、药品容器和密封件的复检
.

Components, drug product containers, and closures shall be retested or reexamined,
as appropriate, for identity, strength, quality, and purity and approved or rejected by the
quality control unit in accordance with 211.84 as necessary, e.g., after storage for long
periods or after exposure to air, heat or other conditions that might adversely affect the
component, drug product container, or closure.





































经质量控制部门批准或拒收的成份、药品容器密封件，若长期贮存或曝 露在空气、热或
其他可能对其产生不良影响的环境后，应依照
211?84
，对均一性 、规格、质量、纯度等
复检

Sec. 211.89 Rejected components, drug product containers, and closures.

拒收的成份、药品容器和密封件

Rejected components, drug product containers, and closures shall be identified and
controlled under a quarantine system designed to prevent their use in manufacturing or
processing operations for which they are unsuitable.
































拒收的成份、 药品容器和密封件应经鉴定和在隔离系统下加以控制，防止因不适当而应
用在生产和加工操作中。

Sec. 211.94 Drug product containers and closures.
药品容器和密封件

(a) Drug product containers and closures shall not be reactive, additive, or absorptive
so as to alter the safety, identity, strength, quality, or purity of the drug beyond the
official or established requirements.















































药品包装容器和密封件应不起反应、不吸着、不吸附、不致改变药品的安全性、均一性、
规格、 质量和纯度而超出制定的或其它颁布的规定要求。

(b) Container closure systems shall provide adequate protection against foreseeable
external factors in storage and use that can cause deterioration or contamination of the
drug product.



































































容器密封系统应对贮藏和使用过程中可预见的能 引起药品变质或污染的外部因素提供足
够的防护。

(c) Drug product containers and closures shall be clean and, where indicated by the
nature of the drug, sterilized and processed to remove pyrogenic properties to assure
that they are suitable for their intended use. Such depyrogenation processes shall be

validated.










药品容器和密 封件应根据药品本身的性质保持清洁、灭菌和除热原，来保证其适用于预
期目的。这种除热原过程要有效 。

(d) Standards or specifications, methods of testing, and, where indicated, methods of
cleaning, sterilizing, and processing to remove pyrogenic properties shall be written
and followed for drug product containers and closures.






























药品容器和密封件的标准或规格、检验方法（指清洁和消毒方法、除热原过程）应 成文
并遵循执行。

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]

Subpart F--Production and Process Controls
生产和加工控制

Sec. 211.100 Written procedures; deviations.
成文的规程、偏差

(a) There shall be written procedures for production and process control designed to
assure that the drug products have the identity, strength, quality, and purity they
purport or are represented to possess. Such procedures shall include all requirements
in this subpart. These written procedures, including any changes, shall be drafted,
reviewed, and approved by the appropriate organizational units and reviewed and
approved by the quality control unit.















































编写为保证药品的均一性、规格、质 量及纯度而设计的生产和加工控制程序，这些程序
包括本部分内全部要求。这些成文程序（包括变更）须 经有关部门起草、复查和批准，
然后再经质量控制部门复查与批准。

(b) Written production and process control procedures shall be followed in the
execution of the various production and process control functions and shall be
documented at the time of performance. Any deviation from the written procedures
shall be recorded and justified. 在实施各种生产和加工控制过程中，遵循已制定的生产
和加工控制程序，并在执行时以文件加以证明 。程序中出现的任何偏差，应作记录，并
提出证据。

Sec. 211.101 Charge-in of components.
成分的进料

Written production and control procedures shall include the following, which are
designed to assure that the drug products produced have the identity, strength, quality,
and purity they purport or are represented to possess:































成份的生产和控制程序包 括下面的内容，其设计应保证所生产的药品具有它应有的或是
代表的均一性、规格、质量和纯度。

(a) The batch shall be formulated with the intent to provide not less than 100 percent of
the labeled or established amount of active ingredient.
































按处方配制的药品，保证其活性成份含量不低于
100%
标示量或规定量。

(b) Components for drug product manufacturing shall be weighed, measured, or
subdivided as appropriate. If a component is removed from the original container to
another, the new container shall be identified with the following information:












生产药品用的成份应称量、
测量或适当 粉碎。
若一种成份从原来容器转移到另一容器内，
新的容器要通过以下信息加以鉴别：

(1) Component name or item code;















































成份名称或项目代码

(2) Receiving or control number;

















































接收或控制号

(3) Weight or measure in new container;











































在新容器中的重量或容量

(4) Batch for which component was dispensed, including its product name, strength,
and lot number.

































































使用此成分配制的一批药品，包含其产品名称、规格和批号

(c) Weighing, measuring, or subdividing operations for components shall be
adequately supervised. Each container of component dispensed to manufacturing
shall be examined by a second person to assure that:































成份的称重、测量或粉碎操作，应受 到严密的监督。所装成份已用于生产的每一容器，
须经第二人检查和保证。

(1) The component was released by the quality control unit;


























此成份是由质量控制人员发放的；

(2) The weight or measure is correct as stated in the batch production records;









重量或容量要正确无误，与批生产记录一致；

(3) The containers are properly identified. If the weighing, measuring, or subdividing
operations are performed by automated equipment under 211.68, only one person is
needed to assure paragraphs (c)(1), (c)(2), and (c)(3) of this section.

容器经严格鉴别。
如 果重量、
容量和详细的操作是自动的仪器遵照
211.68
进行的，
只需要一个人来确认是这部分
(c)(1), (c)(2), and (c)(3)
的章节。

(d) Each component shall either be added to the batch by one person and verified by a
second person or, if the components are added by automated equipment under
211.68, only verified by one person.















































每一成份投料时，一人操作，另一人核对；如果 物料是通过自动仪器根据
211.68
要求加
入，只需要一个人来核对。