杂质对照品的接收、处理和保管标准程序.doc

文件编码Doc. No.:
Page No.: 4 of 5
标题：工作对照品/对照品/杂质对照品的接收、处理和保管标准程序
TITLE: RECEIPT,HANDLING AND MAINTENANCE OF WORKING/REFERENCE AND IMPURITY STANDARD

标准操作程序
Standard Operating Procedure
文件编码Doc. No.:
颁发日期：
Issue Date:
生效日期：
Effective Date:
替代： Supersedes:
复审日期：
Review Date:
页码：第1页共5页Page No.: 1 of 5
标题：工作对照品/对照品/杂质对照品的接收、处理和保管标准程序
TITLE: RECEIPT, HANDLING AND MAINTENANCE OF WORKING/REFERENCE AND IMPURITY STANDARD

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。
Label the vials in Chinese language with following details on the label:
- 产品名称Name of Product
- 批号Batch/Lot Number
- 内部编码In-house ID
- 折算含量Potency on ‘as-is-basis’
- 生产日期Manufacturing Date
- 复测日期Retest Date
- 储存条件Storage Condition
5.2.5 每个接收的对照品依照附录-III做好“工作对照品/杂质对照品使用记录”。
Issue ‘Working/Impurity Standard Usage Record’ as per Annexure-III for each item received.
5.2.6如果相同杂质/工作对照品多于一个小瓶，只能先使用一个。
If more than one vial of same impurity/working standard is available, only one vial should be issued for use.
5.2.7 剩余的小瓶应该作为库存，在前一个小瓶消耗完后，再分发使用。
Remaining vials should be maintained as stock and should be issued after the consumption of previous vial.
5.3 处理Handling
5.3.1确保对照品是有效的，还没过期。
Ensure that the standard is valid and has not expired.
5.3.2 冰箱中的小瓶存放在干燥器中，恢复到室温。
Refrigerated vials should be brought to room temperature by keeping in desiccator.
5.3.3 在确定工作区域是干净的，并且没有前面的污染后，再打开工作对照品的小瓶。
Open the working standard vial after ensuring that the working area is clean and free from previous contamination.
5.3.4 从小瓶中取出需要的数量，如果取出的数量过多，不要把多余的放回去， 丢掉多余的。
Remove only required quantity from the vial, if excess quantity is removed, then do not put it back to vial, discard the excess material.
5.3.5 使用完后，立刻盖紧瓶子，恢复各自的储存条件。
After use, immediately close the vial and return to the respective storage condition.
5.3.6 每个分发的小瓶按照附录-III记录分发情况。
Record the details as per Annexure-III issued for the particular vial.
5.4 保管Maintenance
5.4.1 移走过期的小瓶。
Remove expired vials from the use.
5.4.2 提前取得新对照品，取代过期的对照品。
Procure new standard to replace the expired standard well in advance.
6.0 相关文件 Related Documents:
6.1 外来工作对照品/杂质对照品接收记录（附件-I）
WORKING/IMPURITY STANDARDS RECEIPT RECORD (ANNEXURE-I)
6.2 从外部接收的工作对照品的含量计算记录（附件-II）
POTENCY CALCULATION OF WORKING STANDARD RECEIVED FROM OTHER LACATIONS (ANNEXURE-II)
6.3 外来工作对照品/杂质对照品使用记录（附件-III）
WORKING/IMPURITY STANDARD USAGE RECORD (ANNEXURE-III)
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

******文件终止符END OF DOCUMENT

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

附表-I
ANNEXURE-I
外来工作对照品/杂质对照品接收记录
WORKING/IMPURITY 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
品名
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
从外部接收的工作对照品的含量计算记录
POTENCY CALCULATION OF WORKING STANDARD
RECEIVED FROM OTHER LACATIONS
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
从外部接收的工作对照品的含量计算记录
POTENCY CALCULATION OF WORKING STANDARD
RECEIVED FROM OTHER LACATIONS
工作对照品名称
Name of Working Standard:

工作对照品批号
B. No. /Lot No. of Working Standard:

工作对照品内部编码
In-house ID of Working Standard:

含量%，按无水物/干燥品计
% w/w Assay on anhydrous/dried basis:

含量%，按无水物/干燥品和无溶剂物计
% w/w Assay on anhydrous/dried and solvent free basis:

水分%/干燥失重%
% Water content / Loss on drying:

残留溶剂含量%
% solvent contents:

折算后的含量
Assay/Potency on as is basis: ________________________________

计算人（签名/日期） 复核人（签名/日期）
Calculated by: Checked By:
(Sign/date) (Sign/date)

附件-III
ANNEXURE-III
外来工作对照品/杂质对照品使用记录
WORKING/IMPURITY 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
名称 Name: 接收数量 Quantity Received: 储存条件Storage Condition:
批号Lot No.: 内部编码 In-house ID No.: 纯度/含量Potency:
有效期至Validity:

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