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1、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 STANDARD1.0 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
2、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 imp
3、urities received from R&D & External API vendor.3.0 定义 Definitions: 无 Nil4.0 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 Procedure5.1 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C
4、OA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 cont
5、act 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
6、 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-basi
7、s 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%) 100Assay on anhydrous
8、/dried basis (%w/w) X (100-%Water by KF/LOD) 1005.2.2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 100Assay on anhydrous/dried basis (%w/w) X (100-%Water by KF/LOD) X (100 - % Solvent)
9、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
10、存条件Storage Condition5.2.5 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
11、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Handling5.3.1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 tempera
12、ture 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 rem
13、oved, 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Maintenance5.4.1
14、 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 WO
15、RKING 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附表-IANNEXURE-I外来工作对照品/杂质对照品接收记录WORKING/IMPURITY STANDARDS RECEIPT R
