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1、起草/修订人：Author日期：Date部门主管审查：Dept. Head Approval日期：DateQA批准：Approved by QA日期：Date分 发：Distribution:QA, QC, R&D目的：描述化验室对照品的接收、确认、贮存、库存、分发、使用的规程。PURPOSE:This procedure describes a process used by Lab operation for the receipt, qualification, storage, inventory, distribution and use of analytical referenc
2、e standard范围：适用于化验室内所用的对照品，包括基准对照品、第二对照品。SCOPE:This procedure is applicable to analytical reference standards used in QC lab, includes the Primary Reference Standards and the Secondary Reference Standards参考文件：REFERENCE AND ATTACHMENT:SOP/题目 SOP/TITLE记录/附件/题目 FORMS/ATTACHMENTS/TITLE3-0002OOS调查附件1：对照品
3、标签样例Investigation of Out-of-Specification ResultAttachment 1: Reference Standard Label (Example)F-03-010对照品登记台帐Reference Standard Inventory Log SheetF-03-011对照品接收记录Reference Standard Receiving LogbookF-03-012对照品使用记录Use Record of Reference Standard 定 义：DEFINITIONS:基准对照品以广泛分析表明具有可信的、高纯度的物质。这类标准品可以：1）来
4、源于法定机构；2）独立合成；3）来自于高纯度的现有生产物料；4）用进一步精制现有生产物料的方法来制备。Reference Standard, Primary A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard could be: (1) obtained from an officially recognized source, (2) prepared by in
5、dependent synthesis, (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.第二对照品与基准对照品比较显示有规定的质量和纯度，并用作日常检验分析的参考标准品。Reference Standard, Secondary A substance of established quality and purity, as shown by comparison to
6、a primary reference standard, used as a reference standard for routine laboratory analysis.规 程：PROCEDURE:责 任 人操 作RESPONSIBILITYACTION1.对照品接收RECEIPT OF REFERENCE STANDARDQC主管QC主管指定专人负责对照品的管理；对照品管理员负责对照品的接收、贮存以及发放等的管理。QC SupervisorQC Supervisor designee is responsible for the management of all referen
7、ce standards, such as the receipt, storage and distribution of reference standard.对照品管理员接收对照品时，应检查对照品的包装是否完好、是否提供检验报告书、检验报告书是否与实物相符，等等。Control ClerkUpon receipt, verify the package of the reference standards, confirm whether the certificate of analysis is available, and the reference standards recei
8、ved are the same as the certificate of analysis, etc.将对照品的相关信息在对照品登记台帐上作好记录，每批对照品建立一份管理台帐。Enter reference standard information into the Reference Standard Receiving logbook, and establish a Reference Standard Inventory log sheet for each lot. 接收后的对照品给定公司内批号。Assign the lot number for received referen
9、ce standards对照品的批号由：类别号年号流水号组成：The lot number is consist of: Sort number + digit number of the calendar Year + sequential number:.1类别号：Sort number基准对照品：RSP（Reference Standard, Primary）第二对照品：RSS（Reference Standard, Secondary）.2年号：用2位数的年份表示Year: 2 digit number of the year designation.3流水号：用2位数字表示。Sequ
10、ential number: 2 digit number.对照品接收后，在每批对照品的每个包装上贴签（附件1），标明名称、批号、数量、来源、瓶号/总瓶数（比如，共有10瓶，其中第2瓶为：2/10）、接收人签名/日期等内容。At time of receipt, label each standard container (attachment 1), with the reference standard name, lot number, quantity, source, container number/total containers number (e.g., the total
11、container is 10 bottles, then second bottle is 2/10), and initial and date of the receiver.责 任 人操 作RESPONSIBILITYACTION对照品管理员将对照品放入标有“待确认对照品”的干燥器中，存放于28冰箱中，或者存放于对照品所规定的贮存条件。Control ClerkPlace reference standard into desiccator (marked with “Reference Standard, to be qualified”) in refrigerator (temp
12、erature controlled within 2 to 8 Degree C), or place in required storage condition in accordance with reference standard.对照品应存放于棕色玻璃瓶中，对于不符合此要求的，在接收后，将对照品装入或分装于棕色玻璃瓶中。The reference standard should be stored in brown glass bottles. If it is found not meeting the requirement, it should be placed into
13、or subdivided into brown glass bottles after receipt.2.对照品确认QUALIFICAITON OF REFERENCE STANDARDSQC对照品应从法定机构购买（如，USP、EP、CP等）；并且，只要是适用的，内部使用的对照品应根据这些从法定机构购买来的对照品进行确认。如果法定对照品不能得到，则内部使用的对照品必须根据一个确认的标准品进行确认，或必须根据本SOP中下面的要求的进行全部的确认。Reference standards should be purchased from an officially recognized sour
14、ce (e.g., USP, EP, and CP) and in-house reference standards should be qualified against them, whenever applicable. If officially reference standard is not available or applicable, in-house reference standards must be qualified against a qualified standard or full qualification must be performed according to the following requirement of this SOP.2.2对照品的确认包括：The qualification of reference standard includes:2.2.1基准对照品的确认Qualification of Primary Reference Sta
