CGMP文件 工作对照品杂质对照品的接收处理保管标准程序SOP

1.0目的Purpose:

描述工作对照品/对照品/杂质对照品的接收、处理和保管的标准程序

To lay down a procedure for receipt, handling and maintenance of working standard/

reference standard and impurities.

2.0范围 Scope:

本程序适用于工作对照品/对照品/杂质对照品的接收、处理和保管。这些对照品来自研发部门和外部原料药生产商。

This procedure is applicable for receipt, handling and maintenance of working

standard/reference standard and impurities received from R&D & External API vendor.

3.0定义 Definitions: 无 Nil

4.0责任 Responsibility:

所有的QC人员有责任在他们的岗位上遵循此标准操作程序的操作。

All QC personal are responsible for following this SOP as per their respective roles.

5.0程序 Procedure

5.1接收Receipt:

5.1.1在接收的时候，检查是否有检验报告单（COA）和支持性数据。若没有，

则向厂家索取。检查容器是否完好无损，对比COA和标签的内容。

At the time of receipt, check the availability of Certificate of Analysis (COA)

and supporting data. If not, then ask the source to provide them. Check the

intactness of containers and compare the contents of COA and label.

5.1.2 如果发现不符合之处，跟生产商联系来更正它。

If any discrepancy is observed, then contact supplier to correct them.

5.1.3 按照附录-I的要求记录每个工作对照品/对照品/杂质对照品的接收细节。

Record the receipt details of each working standard/reference standard and

impurities as per Annexure-I.

5.1.4 接收的序号应被视为工作对照品/对照品/杂质对照品的内部编码。

The serial number of receipt should be treated as In-house ID of working

standard/reference standard and impurities.

5.1.5 在COA上注明内部编码，把所有的COA按内部编码的顺序放在单独的文

件夹里。

Mention In-house ID on the COA and keep all COA in a separate file as per In-

house ID.

5.1.6 关于原料药的工作对照品/对照品，检查一下COA和标签上是否折算过的

含量。如果没有，用下面的公式，依据附录-II, 计算折算后的含量。

For working/reference standard for API, check if the potency on ‘as-is-basis’ is

available on COA and label. If not, calculate the potency on ‘as-is-basis’ using

following formula as per Annexure-II.

5.2公式Formula:

5.2.1如果含量是按无水物/干燥品计算

If the assay is on anhydrous/dried basis

折算后的含量(%w/w)：

Potency of ‘as-is-basis’ (%w/w):

按无水物/干燥品计算的含量(%w/w)×(100- KF水分% / 干燥失重%)

100

Assay on anhydrous/dried basis (%w/w) X (100-%Water by KF/LOD)

100

5.2.2如果含量是按无水物/干燥品和无溶剂物计算

If the assay is on anhydrous/dried and solvent free basis

折算后的含量

Potency of ‘as-is-basis’ (%w/w)：

按无水物/干燥品计算的含量(%w/w)×(100- KF水分%/ )×（100-溶剂%）

100 X 100

Assay on anhydrous/dried basis (%w/w) X (100-%Water by KF/LOD) X (100 - % Solvent)

100 X 100

5.2.3将附录-II附在接收的COA后。

Attach Annexure-II to the COA received

5.2.4给小瓶贴上含有下面信息的中文标签。