CGMP文件-药典对照品的接收、储存、使用和保管程序SOP.doc

标准操作程序
Standard Operating Procedure
文件编码Doc. No.:
颁发日期：
Issue Date:
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页码：第1页共4页Page No.: 1 of 4
标题： 药典对照品的接收、储存、使用和保管程序
TITLE: PROCEDURE FOR RECEIPT, STORAGE, USE AND MAINTENANCE OF PHARMACOPOIEAL REFERENCE STANDARD

1.0 目的　Purpose :
规定药典对照品的接收、储存、使用和保管程序。
To lay down a procedure for receipt, storage, use and maintenance of pharmacopoieal reference standard.
2.0 范围　Scope :
本SOP适用于QC实验室从药典部门（USP/BP/EDQM/NICPBP）接收的所有对照品。
This SOP applies to all reference standards used in the QC laboratory, which are received from pharmacopoieal agencies (USP/BP/EDQM/NICPBP).
3.0 定义　Definitions :
USP： 美国药典 United States Pharmacopoeia
BP: 英国药典British Pharmacopoeia
EDQM： 欧洲药品质量理事会European Directorate for the Quality of Medicines
NICPBP： 中国药品生物制品检定所
National Institute for the Control of Pharmaceutical and Biological Products
4.0 责任　Responsibility:
QC 检验员/组长/经理助理/经理
QC analysts/Group Leader/ Assistant Manager/ Manager
5.0 程序　Procedure :
5.1接收和储存Receipt and storage
5.1.1 对照品应从药典部门或其授权代理机构购买。
Reference standards should be procured from pharmacopoieal agency or by their authorized agent.

制定人
Prepared by
审核人
Reviewed by
批准人
Approved by
签名/日期
Sign / Date

名字
Name

职务
Designation

文件编码Doc. No.:
Page 4 of 4
标题： 药典对照品的接收、储存、使用和保管程序
TITLE: PROCEDURE FOR RECEIPT, STORAGE, USE AND MAINTENANCE OF PHARMACOPOIEAL REFERENCE STANDARD

5.1.2 接收对照品时应从下列网站下载最新的对照品目录并检查是否现行批号。
On receipt of reference standards, check whether the lot is current or not from the latest catalogs downloaded from following websites:
- USP对照品For USPRS: www.usp.org
- EP对照品For EPCRS: www.pheur.org
- BP对照品For BPCRS: www.bpclab.co.uk
- Ch.P对照品 For Ch.PRS:
5.1.3 检查瓶子包装应完好无损，标签正确无误。
The vial should be checked for intactness and correctness of label.
5.1.4 接收情况应在附件-I中所示的《对照品接收记录》中记录
The receipt should be recorded in the ‘Reference Standards Receipt Record’ as per Annexure-I.
5.1.5 对照品序号应作为内部编码并用以使用情况追溯。
The serial number should be treated as In-house identification number and should be used for reference purpose.
5.1.6任何相关资料、包装的完好无损、现行批号状况和有效期（如果有）应记录在备注栏中。
Receipt of any literature, intactness of vial, current lot status and expiry date (If applicable) should be recorded in the remark column.
5.1.7 所有对照品应按药典机构在标签上或个别文件中描述的储存条件进行储存。
All reference standards should be stored at storage conditions as prescribed by the pharmacopoieal agency on the label or in respective documents.
5.1.8 如果接收的同一种对照品不止一瓶，则只能发放一瓶在使用记录中登记并使用（如附件-II所示）。
If more than one vial of the same reference standard is received, only one vial and usage record (As per Annexure-II) should be issued for use.
5.1.9同种对照品的剩余瓶数应储存并收藏起来，前一瓶使用完后，接着再发放下一瓶，并在如附件-II所示的《对照品使用记录》中登记。
Remaining vials should be maintained as stock and after consumption of previous vial, next vial of same reference standard and ‘reference standard usage record’ as per Annexure-II could be issued for use.
5.2对照品的使用Use of reference standards
5.2.1 确保对照品批号是现行有效的批号，并且瓶中无异常情况。
Ensure the reference standard is of current lot and there is no abnormality in the vial.
5.2.2 使用对照品应注意避免所有污染和溢出。
Take all necessary precautions to avoid any contamination and spillage during using the reference standards.
5.2.3 打开瓶子前确保放置区域清洁且无以前样品的残留。
Ensure the area is clean and free from traces of previous products before opening the vial.
5.2.4 冰箱储存的对照品使用前应放在干燥器中升到室温。
Refrigerated vials should be allowed to equilibrate to room temperature by keeping them in desiccators before use.
5.2.5 打开瓶子，只取出要求数量的对照品，取出的剩余对照品应丢弃，不得倒回瓶中。
Open the vial and take only required quantity of material, remaining removed material should be discarded and should not pour back to the vial.
5.2.6 使用完毕立即盖紧瓶盖并在瓶颈周围绕上封口膜。
Immediately after use, close the vial with original cap and wrap Para-film around the neck of the vial.
5.2.7 分别按各自储存条件储存对照品。
Store the vial to respective storage condition.
5.2.8 在附件-II所示的《对照品使用记录》中登记。
An entry for the usage should be made in the ‘Reference Standard Usage Record’ as per Annexure-II.
5.3 对照品的保管Maintenance of reference standards
5.3.1 应对照现行对照品目录检查现有对照品。（参照“5.1 接收和储存”中下载的现行对照品目录）。
Current lot of reference standards should be checked against current catalogs. (Refer ‘5.1 Receipt and storage’ for downloading the current catalogs).
5.3.2 每月的第一周应检查对照品的储存情况，所有失效或用完的瓶子应从储存处移除并销毁。
First week of every month, stock of reference standards should be reviewed and any expired/exhausted vial should be removed from the stock and should be destroyed.
5.3.3 应按附件-II所示的《对照品使用记录》中记录销毁情况。
Entry for destruction should be made in ‘Reference Standard Usage Record’ as per Annexure-II.
6.0 相关文件　Related Documents:
6.1 对照品接收记录（附表-I）
REFERENCE STANDARDS RECEIPT RECORD (Annexure-I)
6.2 对照品使用记录（附表-II）
REFERENCE STANDARD USAGE RECORD (Annexure-II)
7.0 修订记录　Revision Record:

序号
Sl. No
版本号
Revision Status
修订内容
Details of Revision
备注
Remarks

******文件终结符END OF DOCUMENT

附表-I
ANNEXURE-I
对照品接收记录
REFERENCE STANDARDS RECEIPT RECORD
参照文件编码Doc. Ref. No. : 表格号Form No. :
生效日期Effective Date:
第1页共1页page 1 of 1
序号
S. No.
接收日期
Date of Receipt

对照品名称
Reference Standard Name
对照品来源
Source
批号
Lot No.
储存条件
Storage Condition
接收数量
Quantity Received
接收人Received by
备注
Remark

附件-II
ANNEXURE-II
对照品使用记录
REFERENCE STANDARD USAGE RECORD
参照文件编码 Doc. Ref. No. : 表格号Form No. :
生效日期Effective Date:
第1页共1页page 1 of 1

对照品名称 接收数量 储存条件
Name of Reference Standards: Quantity Received: Storage Condition:
批号 内部编码 纯度/含量：
Lot No.: In-house ID No.: Potency:

日期
Date
品名
Product Name
批号/报告单号
Batch No./AR No.
检验项目
Test Parameter
取用对照品数量
Quantity Used
剩余对照品数量Quantity Remained
检验员
Analyst
备注Remark