Annex 5:

《Good Manufacturing Practice (2010 revision) 》

Annex1 to Annex5 Technical Reviewed by ISPE

Michael Lee, Zhao Chunhua

Zhao Yunxia, He Guoling, Ji Yiyun

Initial Translation from NNE Pharmaplan

附录5：中药制剂

Annex 5 Chinese Medicine Preparations

第一章 范围

Chapter 1 Scope

第一条 本附录适用于中药材前处理、中药提取和中药制剂的生产、质量控

制、贮存、发放和运输。

Article 1: This annex applies to the pretreatment of Traditional Chinese

Medicinal Materials (TCMMs), extraction of Traditional Chinese Medicines

(TCMs), and the production, quality control, storage and transportation of

Chinese Medicine Preparations (CMPs).

民族药，如藏药、苗药、蒙药等参照本附录执行。

Refer to this annex for folk medicine, such as Tibetan, Miao Medicine, Mongolian,

etc.

第二章 原则

Chapter 2 Principle

第二条 中药制剂的质量与中药材和中药饮片的质量、中药材前处理和中药

提取工艺密切相关。应对中药材和中药饮片的质量以及中药材前处理、中药提取

工艺严格控制，防止在中药材前处理、中药提取、贮存和运输过程中的微生物污

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染和变质。

Article 2: The quality is closely related to quality and pretreatment of TCMMs

and the extraction process of TCMs. Therefore, the process should be strictly

controlled to prevent from the microorganism contamination and degeneration in

the process of pretreatment for TCMMs, and extraction and storage of TCMs.

第三条 中药材来源应相对稳定，必要时可监督收购。注射剂生产所用中药

材的产地应与注册申报资料中的产地一致，并尽可能采用规范化生产（如中药材

GAP）的中药材。

Article 3: The source of TCMMs should be relatively stable. The purchasing

activities could be monitored when necessary. The origin of the TCMs used for

the parenteral production should be consistent with the declared origin in the

registration, and production should follow good manufacturing practices. (for

example, TCMs GAP, Good Agriculture Practice)

第四条 为确保产品质量的控制，中药制剂质量标准在法定标准的基础上可

适当增加新的检验项目。

Article 4: New testing items for quality standards of CMPs can be added

appropriately based on the mandatory specifications to ensure the quality of the

products is in control.

第五条 厂房应根据生产工艺要求采取密闭、通风、排风、除尘、除湿、空

气净化等措施。

Article 5: Measures for premises should be taken in accordance with

requirements of production process including sealing, ventilation, air exhaustion,

dust removal, dehumidification, air purification, etc.

第三章 机构与人员

Chapter3 Organization and Personnel

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第六条 企业的质量管理部门应有专人负责中药材和中药饮片的质量管理。

Article 6: There should be designated persons in Quality Management

Department to be responsible for the quality management of TCMMs.

第七条 专职负责中药材和中药饮片质量管理的人员应至少具备以下条件：

Article 7: The persons who are responsible for the quality management of

TCMMs should at least have the following qualifications:

1. 具有中药学、生药学或相关专业大专以上学历，并至少有三年从事中药生

产、质量管理的实际工作经验；或具有专职从事中药材和中药饮片鉴别工作八年

以上的实际工作经验；

1. They should have college degrees of TCM, pharmacognosy or related majors,

and at least have three years practical experience in TCM production and quality

management, or have practical experience in the identification of TCMMs for

more than eight years.

2. 具备鉴别中药材和中药饮片真伪优劣的能力；

2. The capability to identify real or fake and the quality of TCMMs.

3. 具备中药材和中药饮片质量控制的实际能力；

3. The practical capability to control the quality of TCMMs.

4. 根据所生产品种的需要，熟悉相关毒性中药材和中药饮片的管理与处理要

求。

4. Familiar with the requirements of management and handling of the toxic

TCMMs according to the production needs.

第八条 专职负责中药材和中药饮片质量管理的人员主要从事以下工作：

The person who are responsible for the quality management of TCMMs should

engage in the following working areas:

1. 中药材和中药饮片的取样；

1. To sample TCMMs;

2. 中药材和中药饮片的鉴别、质量评价，提出中药材和中药饮片是否放行的

决定；

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2. To identify and evaluate the quality of TCMMs, and propose whether the

TCMMs should be released.

3. 培训中药材处理操作人员，包括毒性中药材处理操作人员；

3. To train the operators how to handle TCMMs, including toxic TCMMs.

4. 中药材和中药饮片标本的收集、制作和管理。

4. To collect, prepare and manage the specimens of TCMMs.

第四章 厂房设施

Chapter 4 Premises and Facilities

第九条 中药材和中药饮片的取样、筛选、称重、粉碎、混合等操作，如易

产生粉尘，应采取有效措施以控制粉尘扩散，避免污染和交叉污染，如安装捕尘

设备、排风设施或设置专用厂房（操作间）等。

Article 9: Effective measures should be taken for production steps of TCMMs

which are easy to generate dust, such as sampling, screening, weighing, milling,

and mixing, etc. to contain dust, and avoid contamination and

cross-contamination, including installation of dust-traps, ventilation facilities or

set up dedicated premises (operation room), etc.

第十条 中药材前处理的厂房内应设拣选工作台，工作台表面应平整、易清

洁，不产生脱落物。

Article 10: Picking benches should be set up in the pretreatment premises of

TCMMs, and their surface should be smooth, easy to clean and non-flakes off.

第十一条 中药提取、浓缩等厂房应与其生产工艺要求相适应，有良好的排

风、水蒸汽控制及防止污染和交叉污染等设施。

Article 11: Premises for extraction and concentration of TCMMs should be

consistent with process requirements, and be equipped with good ventilation

systems, and steam control, anti-contamination and anti cross-contamination

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measures, etc.

第十二条 中药提取、浓缩、收膏工艺宜采用密闭系统以防止污染。采用密

闭系统生产的，其操作环境可在非洁净区；采用敞口方式生产的，其操作环境应

与其制剂的配制岗位的洁净度级别相适应。

Article 12: The extraction, concentration and collecting cream process of

TCMMs should use closed system to prevent contamination. The production

environment could be in non clean area for closed system; and the

environmental control level at the open point should be consistent with the

cleanliness class of the compounding step in formulation.

第十三条 中药提取后的废渣如需暂存、处理时应有专用设施。

Article 13: There should be dedicated facilities for temporary storing and

handling of residues from extraction step.

第十四条 浸膏的配料、粉碎、混合、过筛等操作，其洁净级别应与其制剂

的配制岗位的洁净度级别一致。用于直接入药净药材的粉碎、混合、过筛等厂房

应能密闭，有良好的通风、除尘等设施，人员、物料进出及生产操作应参照洁净

区管理。

Article 14: The cleanliness class of operations such as preparation, comminution,

mixing, and sifting of exudates should be consistent with the cleanliness class of

the compounding step of formulation process. The premises for crushing, mixing

and screening of the directly used TCMMs should be a closed system. There

should have good ventilation, dust collection facilities and the person and

material flow, production operation should refer to the management of the

cleanrooms.

第十五条 中药注射剂浓配前的精制工序应至少在D 级洁净区内完成。

Article 15: For injection CMPs, the final purification process should be performed

at least in Grade D area.

第十六条 非创伤面外用中药制剂及其他特殊的中药制剂可在非洁净厂房内

生产，但必须进行有效的控制与管理。

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Article 16:CMPs for external use of non-traumatic surface and other particular

CMPs can be produced in non-clean premises, but must be controlled and

managed effectively.

第十七条 中药标本室应与生产区分开。

Article 17: Specimens room of TCMs should be separated from the production

area.

第五章 物料

Chapter 5 Material

第十八条 对每次接收的中药材来货按产地、采收时间、采集部位、药材等

级、药材外形（如全株或切断）、包装形式等分类，分别编制批号并管理。

Article 18: Each received TCMMs should be classified by their origin, harvest

time, part of collection, grade and shape (e.g. whole plants or cut-off plants),

packaging format, etc. and identified and managed by lot numbers.

第十九条 购入的中药材外包装上应标明品名、产地、采收（加工）时间、

规格；中药饮片和中药提取物的外包装上应标明品名、批号、规格、加工时间、

加工企业名称等，并有合格证。

Article 19: The packaging of the purchased TCMMs should be labeled with the

name, origin, time of harvesting (processing), specifications. The packaging of

the TCMMs and the extraction of TCMs should be labeled with name, batch

number, specification, produ tion time, manufacturer, etc. and the certificate

should be provided.

第二十条 应设置原药材库和净药材库分别贮存各类中药材和中药饮片，并

按照法定质量标准项下规定的贮藏条件贮存；贮存鲜活中药材应有适宜的设施（如

冷藏设施）。

Article 20: The raw medicinal material storage and the clean material storage for

TCMMs should be separated; The storage condition should be in accordance

with the regulated quality standard. The fresh TCMMs should be stored in proper

storages (for example, the cold storage facilities)

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第二十一条 毒性和易串味的中药材和中药饮片应分别设置专库（柜）存放。

Article 21: Toxic and smelly TCMMs should be stored in dedicated

storages(cupboards).

第二十二条 仓库内应配备适当的设施，同时应采取有效措施，保证中药材

和中药饮片、中药提取物以及中药制剂的贮存符合其湿度、温度或照度的特殊要

求，并进行监控。

Article 22: The storage area should have appropriate facilities and effective

measures to ensure that TCMMs, extracts of TCMs, and CMPs are stored with

required humidity, temperature or light protection; these conditions should be

provided and monitored.

第二十三条 贮存的中药材和中药饮片应定期养护管理，仓库应保持空气流

通，应配置相应的设施或采取安全有效的养护方法，防止昆虫、鸟类或啮齿类动

物等进入，防止任何动物随中药材和中药饮片带入仓储区而造成污染和交叉污染。

Article 23: The stored TCMMs and prepared slices should be maintained

regularly. The storage area should be well aerated, and be equipped with

appropriate facilities or safe and effective measures to give protection against

the entry of insects, birds or rodents etc, and prevent the spread of any such

animals brought in with the TCMMs to prevent cross-contamination.

第二十四条 在运输过程中，应采取有效可靠的措施，防止中药材和中药饮

片、中药提取物以及中药制剂发生变质。

Article 24: The effective and reliable measures should be taken to prevent

against any quality changes of TCMMs, extracts of TCMs, and CMPs during

transportation.

第六章 文件管理

Chapter 6 Document Management

第二十五条 应制定能有效控制产品质量的生产工艺规程和其他标准文件：

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Article 25: The manufacturing procedures and other standard documents should

be established to effectively control the quality of products:

1. 制订中药材和中药饮片养护制度，并分类制订养护操作规程；

1. Maintenance system for TCMMs should be established, and the operation

procedures should be established and classified.

2. 制订每种中药材前处理、中药提取、中药制剂的生产工艺和工序操作规程，

各关键工序的技术参数必须明确，如：标准投料量、提取、浓缩、精制、干燥、

过筛、混和、贮存等要求，并明确相应的贮存条件及时限；

2. Production process and operating procedures for pretreatment of TCMMs,

extraction of TCMs, and CMPs should be established; and the parameters for

each critical production step must be clear, e.g. the standard feed amount, and

the requirements of extraction, concentration, refinement, drying, screening,

mixing and storage etc. The storage conditions and time limits should also be

clear and definite.

3. 根据中药材和中药饮片质量、投料量等因素，制订和执行每种中药提取物

的收率限度范围；

3. The yield range of each extract of TCMMs should be established and

implemented according to factors such as the quality of TCMMs and charging

rate;

4. 制订每种经过前处理后的中药材、中药提取物、中药制剂的质量标准和检

验方法。必要时还应制定中药制剂中间产品的质量标准和检验方法。

4. The quality standards and testing methods for each pretreated TCMMs,

extracts of TCMs, and CMPs should be established. Where necessary, the

quality standards and testing methods for intermediate products of CMPs should

also be established.

第二十六条 应对从中药材的前处理到中药提取物整个生产过程中的生产

管理、生产卫生管理以及质量管理情况进行记录。

Article 26: The situation of production management, production hygiene

management and quality management of the process from pretreatment to

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extraction should be recorded.

1. 当几个批号的中药材和中药饮片混合投料时，应记录本次投料所用每批中

药材和中药饮片的批号和数量；

1. The batch numbers and the quantity for each batch of TCMMs used in mix

charging should be recorded.

2. 中药提取各生产工序操作记录应包括提取、浓缩、收膏、精制等；

2. The operation records for production of extracts of TCMs should include the

extraction, concentration, collection of exudates, purification, etc;

(1) 中药材和中药饮片品名、批号、投料量及监督投料记录；

(1) Records for material name, batch number, quantity of charging and charging

monitoring.

(2) 提取工艺的设备编号、相关溶媒、浸泡时间、升温时间、提取时间、提取

温度、提取次数、溶剂回收等记录；

(2) Records for equipment numbering, related solvents, time of dipping, time of

heating-up, time of extraction and recycling of solvent.

(3) 浓缩和干燥工艺的设备编号、温度、浸膏干燥时间、浸膏数量记录；

(3) Records for concentration and drying process, including concentration

equipment number, concentration temperature, drying time and the extraction

quantity of drying exudates;

(4) 精制工艺的设备编号、溶剂使用情况、精制条件、收率等记录；

(4) Records of refine process, including equipment number, solution usage,

refine conditions, recovery rate, etc.

(5) 其他工序的操作记录；

(5) Operation records for other production process.

(6) 中药材和中药饮片的废渣处理记录。

(6) Records of TCMMs residue treatment.

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第七章 生产管理

Chapter 7 Production Management

第二十七条 中药材使用前应按规定进行拣选、整理、剪切、洗涤、浸润或

其它炮制加工，未经处理的中药材不得直接用于提取加工。

Article 27: TCMMs should be selected, sorted, sheared, washed, dipped or

carried out by required process before use; the unprocessed materials should

not be directly used for the extraction.

第二十八条 中药注射剂所需的中药材必须采购原药材由企业自行加工处

理。

The TCMMs used for TCMs injection should be the raw TCMMs, and being

processed by the manufacturer.

第二十九条 鲜用中药材采收后应在规定的时限内投料，可存放的鲜用中药

材应采取适当的措施保存，保存的条件和时限应有规定并经验证确认，不得对产

品质量和预定用途有不利影响。

Article 29: The TCMMs used fresh should be charged within a defined period.

Appropriate measures should be taken to store the fresh used TCMMs. The

storage condition and time limit should be regulated and validated to ensure

there is no adverse affect on the product quality and the intended use.

第三十条 在生产过程中应采取以下措施防止微生物污染：

The following measures should be taken during the production process to

prevent from the microorganism contamination:

1. 处理后的中药材不得直接接触地面，不得露天干燥；

1. The treated TCMMs should not directly contact with the floor and should not

be dried in the open air.

2. 应使用流动的工艺用水洗涤拣选后的中药材，用过的水不得用于洗涤其他

药材，不同的中药材不得同时在同一容器中洗涤；

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2. The selected TCMMs should be washed by flowing water. The used water

should not be used for washing other TCMMs. Different TCMMs should not be

washed in the same container simultaneously;

第三十一条 毒性药材和饮片的操作应有防止污染和交叉污染的措施。

Article 31: Provisions for the operation of toxic TCMMs should be made to avoid

contamination and cross-contamination.

.

第三十二条 中药材洗涤、浸润、提取用工艺用水的质量标准不得低于饮用

水标准，无菌制剂的提取用工艺用水应采用纯化水。

Article 32 The quality of process water used for washing, dipping and extracting

of TCMMs should not less than the portable water standard. The water used for

extraction of sterile Chinese Medicine preparations should be the purified water.

第三十三条 应有经批准的回收溶媒的方法，回收后溶媒的再使用不得对产

品造成交叉污染，不得对产品的质量和安全性有不利影响。

Article 33: There should be an approved method for solvent recovery. The reuse

of recycled solvent should not cause any cross-contamination to products, and

should not affect on the quality and safety of products.

第八章 质量管理

Chapter 8 Quality Management

第三十四条 中药材和中药饮片的质量应符合国家药品标准及省（自治区、

直辖市）中药材标准和中药炮制规范，并在现有技术条件下，根据对中药制剂质

量的影响程度，在相关的质量标准中增加必要的质量控制项目。

Article 34: The quality of TCMMs should meet the national standards of

pharmaceutical products and the provincial (autonomous regions’ and

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municipalities’) processing specifications. Under the existing technical

conditions the necessary quality control items should be added to related

standards according to their impact on TCMMs.

第三十五条 中药提取、精制过程中使用有机溶剂的，如溶剂对产品质量和

安全性有不利影响时，应在中药提取物和中药制剂的质量标准中增加残留溶剂限

度。

Article 35: When using organic solvents during TCMMs extraction, refining

process and the solvent could have adverse affect on product quality and safety,

the limits of residual solvents should be added in quality standard of TCMMs

extracts and CMPs.

第三十六条 中药材和中药饮片的质量控制项目应至少包括：

Article 36 The items of quality control for TCMMs should at least include:

1. 鉴别；

1. Identification;

2. 中药材和中药饮片中所含有关成分的定性或定量指标；

2. The qualitative and quantitative indicators of related ingredients in TCMMs;

3. 已粉碎生药的粒度检查；

3. The granularity measurement of crushed pharmacognostic products;

4. 直接入药的中药粉末还应包括入药前的微生物限度检查；

4. The test of microbial limits for the powder of TCMMs used directly for mixing

should be done before the process starting;

5. 外购的中药饮片应增加相应原药材的检验项目；

5. The raw medicinal material testing should be added to the outsourced

Traditional Chinese Herbal Pieces;

6. 其它必要的检验项目。

6. Other necessary testing items.

第三十七条 应对回收溶剂制订与其预定用途相适应的质量标准。

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Article 37: The quality standards for recycled solvent should be established

and be appropriate with their intended purpose.

第三十八条 应建立企业生产所用中药材和中药饮片的标本，如原植（动、

矿）物、中药材使用部位、处理后药材、经批准的替代品、伪品等标本。

Article 38: The specimens of TCMMs used for production should be established

by manufacturers, e.g. the original plants (animals, minerals), used parts, treated

materials, approved substitutes and counterfeits, etc.

第三十九条 对使用的每种中药材和中药饮片应根据其特性和贮存条件，规

定贮存期限，定期复检。

Article 39: The time-limit on the storage of each adopted TCMMs should be set

down according to their characteristics and the storage conditions. They should

be reviewed regularly.

第四十条 中药材和中药饮片、中间产品的贮存条件和贮存期限应根据其特

性和包装方式以及稳定性考察的结果来确定。

Article 40: Stability research for TCMMs and intermediate products should be

carried out according to their characteristics and packaging containers in order

to determine the storage conditions and time limit.

第四十一条 每批中药材或中药饮片应留样，留样量应至少能满足鉴别的需

要，留样时间应有规定；用于中药注射剂的中药材或中药饮片的留样，应保存至

使用该批中药材或中药饮片生产的最后一批制剂产品放行后一年。

Article 41: Samples for each batch of TCMMs should be retained. The amount of

the reserved samples should at least satisfy the needs of identification.

Reserved samples should be kept for one year after the expiration date of

corresponding preparations.

第四十二条 应保存中药材和中药饮片贮存期间各种养护操作记录。

Article 42 The maintenance and operation records of the TCMMs should be kept

during its storage period.

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第九章 委托生产

Chapter 9 Contract Manufacturing

第四十三条 中药材前处理和中药提取的委托生产还应符合以下要求：

Article 43: The following requirements about contract manufacturing for the

pretreatment of

TCMMs:

1. 委托生产使用的中药材和中药饮片来源和质量应由委托方负责；

1. The source and quality of TCMMs should be validated by contract giver

before commission.

2. 委托方应制定委托生产产品质量交接的检验标准并检验；

2. The quality testing standards for the handover of contract manufacturing

products should be established, and tested by the contract consignor;

3. 委托生产的产品放行时，应查阅中药材和中药饮片检测报告书，确认中药

材和中药饮片的质量。

3. Before product release, the testing reports of TCMMs should be consulted in

order to validate the quality.

第四十四条 中药提取的委托生产还应注意以下事项，并在委托生产合同中

确认：

Article 44: Attention should be paid on the following aspects for contract

extraction of TCMs, and should be confirmed in the contract manufacturing

agreement:

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1. 所使用中药材和中药饮片的质量标准；

1. The quality standards of TCMMs;

2. 中药提取物的质量标准；

2. The quality standards for the extract of TCMs;

3. 中药提取物的收率范围；

3. The yield range of extracts;

4. 中药提取物的包装容器、贮存条件、贮存期限；

4. The packaging containers, storage conditions and storage time limit of

extracts;

5. 中药提取物的运输条件：

5. The transportation of extracts:

(1) 中药提取物运输包装容器的材质、规格；

(1) The material and specification of packaging containers used for

transportation of extracts;

(2) 防止运输中质量改变的措施。

(2) Measures for preventing quality change during transportation;

6. 中药提取物交接的确认事项：

6. Handover of the extracts:

(1) 每批提取物的交接记录；

(1) The handover records for each batch of extracts;

(2) 受托人应向委托人提供每批中药提取物的生产记录。

(2) The contract manufacturer should provide the production records for each

batch of extracts to the contract consignor.

第十章 术语

Chapter 10 Glossary

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1. 原药材

指未经前处理加工或未经炮制的中药材。

1. Raw Medicinal Material

Traditional Chinese Medicinal Materials which have not been pretreated and

processed.

Annex 5 reviewed by Zhao Chunhua__