QUALITY MANAGEMENT质量管理

There should be a quality unit（s） that can act independently in releasing or rejecting RSM outside the control of the manufacturing company.

应有质量部门独立自主地放行或拒签而不受公司的控制。

All quality related activities and responsibilities should be defined and documented.

所有与质量相关的活动和责任均应被定义并记录。

All quality related activities should be recorded at the time they are performed.

所有与质量相关的活动应同步记录。

Quality critical deviations from established procedures should be documented and evaluated prior to release. Where appropriate, the deviations should be investigated and the conclusions documented.

在放行前，应记录并评估所有偏离既定规程的质量重大偏差。适当时，偏差应被调查并记录结论。

Internal Audits （Self Inspection）内部审计

The organization shall conduct internal quality related audits of the relevant departments and systems at planned intervals. These audits should be documented.


应按照计划时间对相关部门和系统进行质量相关的内部审计。这些审计应被记录。

The audit should be performed by person（s） independent from the area audited.

应由独立于被审计部门的人员进行审计。

Buildings and facilities厂房和设施

There should be defined areas/systems for the following activities including but not limited to:

应有确定区域/系统可供下列活动，包括但不限于：

- Receipt, identification, quarantine and release of incoming materials;

入库物料的接收、验收、和放行

- Rejected materials;

不合格物料

- Sampling of RSM;

起始物料的取样

- Production Operations;

生产操作

- Laboratory Operations;

实验室操作

- Storage of final RSM.


最终产品的储存


Maintenance and cleaning of equipment设备维护和清洁

There must be written instructions for equipment cleaning. These should contain at least:

应有设备清洁的书面规程。至少包括：

cleaning agents and minimum volumes

清洁剂和最小量

acceptance criteria

可接受标准

instructions for the dismounting and subsequent mounting of each piece of equipment to ensure correct cleaning, if necessary

如有必要，应有说明描述每个设备如何拆卸和安装以确保正确清洁

instructions for the protection of cleaned equipment parts against contamination before use inspection of equipment for cleanness before use

应有说明描述已清洁的设备部件在使用前如何保护不受污染

Containment 污染

As a general principle production activities of highly toxic materials, herbicides and pesticides should not be conducted in the same equipment and area as used for the production of RSM unless there are circumstances where the RSM manufacturer has appropriate controls in place and the customer agrees.

高毒性物料的生产活动的一般原则，用于起始物料生产所用的设备和区域不得使用除草剂和杀虫剂，除非起始物料生产商有适当的控制和用户协议。

Computerised systems 计算机化系统

Computer systems should have sufficient control mechanisms to prevent unauthorised access to or altering of data.

计算机系统应有足够的控制机制来防止未经授权的访问或更改数据。

Validation 验证

The complete validation program as required for active pharmaceutical ingredients is not expected. The starting material manufacturer should, however, provide proof of the consistency and stability of his production processes, cleaning procedures, analytical methods, etc.

不期望活性药物成分所需的完整验证程序。然而，起始材料制造商应提供生产工艺，清洁程序，分析方法等的一致性和稳定性的证明。

LABORATORY CONTROLS 实验室控制

Appropriate specifications including acceptance criteria for impurities （e.g.  residual solvents, elemental impurities, related substances） should be  established for RSM consistent with the Starting Material manufacturing  process.

考虑起始物料的生产过程，应为起始物料建立适当的标准，包括杂质的接受标准（如残留溶剂，元素杂质，有关物质）。

Master production instructions 主生产指令

Master production instructions for the RSM should include but not be limited to:

起始物料的主生产指令应包括但不限于：

The name of the RSM being manufactured

所生产起始物料的名称

A complete list of raw materials and intermediates of the RSM;

原料和介质的完整清单

The quantity or ratio of each raw material or intermediate to be used,  including the unit of measure;

每一个原料或介质的量或比例，包含测量单位

The production location and major production equipment to be used;

生产地点和主要生产设备

Detailed production instructions, including the:

详细的生产指令，包括：

sequences to be followed,

所遵循的序列

ranges of process parameters to be used,

所用工艺参数的范围

in-process controls with their acceptance criteria, where  appropriate,

过程控制及其接受标准，如适用

sampling.

取样

The instructions for storage of the RSM to assure its suitability for use.

起始物料的储存要求以确保其适合使用

Batch Production Records （Batch Production and Control Records）批生产记录

Batch Production Records should be prepared and completed for each batch of  RSM and should include complete information relating to the production and  control of each batch. The Batch Production Record may be electronic or paper  and should include at least but not be limited to:

每批起始物料均应有批生产记录，应包括每批生产和控制相关的完整信息。批生产记录可以电子或者纸质，并应包括但不限于：

Dates and when appropriate times,

日期，适当时包括时间

Equipment used,

所用设备

Record of equipment cleanliness,

设备洁净度的记录

batch numbers and quantity of the raw materials,

批号和原料的量

actual values of the process parameters,

工艺参数的实际值

description of packaging

包装的描述

Laboratory Control Records   实验室控制记录

Laboratory control records should include all tests conducted to ensure  compliance with established specifications; the documentation should include  but is not limited to:

实验室控制记录应包括所进行以确保符合既定标准的所有测试，记录应包括但不限于：

A record of samples received for testing;

待测样品接收的记录

A statement of or reference to each test method used;

所用每一个测试方法的说明或参考

A record of the actual weight or measure of sample and reference standards, if applicable, used for each test;

每一个测试样品、参考标准的实际称量或测试记录，如适用。

Raw data generated during each test;

测试期间所产生的原始数据

A record of all calculations performed in connection with the test;

与测试有关的所有校准记录

The signature of the person who performed each test and the date（s） the tests were performed; and

执行测试人员的签名和日期，以及

The date and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established specifications before release.

显示原始记录已被审核其准确性、完整性和符合既定标准的第二人签名和日期