SOP_QC003 v1.0_Laboratory Record Management 实验室记录管理.docx

Page 1 of 101 Purpose 目的：The purpose of this document is to describe the key requirements for recording in QC laboratory. 本文件用以描述 QC实验室记录的关键要求Standard Operation Procedure 标准操作程序SOP_QC003 v1.0 LaboratoryRecordManagement实验室记录管理Effective Date 生效日期:Drafted by 起草： Date 日期: Reviewed by 审核: Date 日期: Approved by 批准: Date 日期:SOP_QC003 v1.0 Laboratory Record Management 实验室记录管理Page 2 of 102 Scope 范围：This procedure applies to QC lab in Nantong Taitong Chemical Technology Co., Ltd.本程序适用于盐城开元医药化工有限公司的QC实验室3 Review Frequency 审阅频率：Every three years每三年一次。

4 Procedure 程序：Upon sample receipt, register the sample information (including material name, batch number, quantity, inspection No. , etc.) And receiver/date on the logbook. (Annex 2 Sample receiving logbook templates) The inspection No. is coded as 4-digit of year+2-digit of month+3-digit of sequential number. Every month starts from 001. Example: 201003001.样品接收时，在日志上登记样品信息（包括物料名称、批号、数量、测试号等）和接收人/日期（附件2 样品接收日志模版）测试号的编码原则为四位年份，二位月份，三位流水号，每月从001开始例如201003001Print approved primary record blank sheet (Annex 3 Primary record template). Perform analytical testing as regulated in the approved analytical method. Every test or series of tests should be signed and dated. Instrument logbook (Annex 1 Instrument logbook template) shall be recorded meanwhile.打印已批准的物料测试原始空白记录（附件3 原始记录模版）。

根据已批准的分析方法进行分析测试，每一项测试或测试系列必须有签名和日期同时应在仪器工作日志（附件1 仪器工作日志模版）上登记All GMP relevant data, including test item, instrument used, parameter, brief description of the test procedure, the information about reference standard, reference standard and sample weighing, observations under identification tests, primary data, calculating formula, calculating result, and testing conclusion must be securely recorded in a manner that allows for trend analysis and traceability to personnel, equipment and procedures used.所有GMP相关数据，包括测试项目、所用仪器、参数、测试步骤的简要描述、所使用对照品的信息、对照品和样品称重，鉴别测试观察到的现象、原始数据、计算公式、计算结果、测试结论等。

包括计算在内，必须保证有相应记录，以利于趋势分析和保证人员、仪器和所使用程序的可追溯性All entries should be made in indelible ink and must be legible.使用水笔誊写数据，书写必须清晰可辨SOP_QC003 v1.0 Laboratory Record Management 实验室记录管理Page 3 of 10Records showing what were done and the results obtained must be made at the time of the tasks. Information is recorded as it occurs or as soon as possible thereafter. Backdating records is not acceptable.边测试边记录所发生的行为和结果，尽快记录所发生的信息不得事后补记Instrument printouts should be stuck securely in the primary record and labeled correctly to identify the substance being tested and signed/dated across the edge of the paper (cross-signed). If the printout is archived separately, the material name, batch number, signature of analyst and date should be on the printout. 将仪器打印页牢固地粘贴在原始记录上，正确注明所测物质，并骑缝签名。

如果打印页需单独存放，必须在打印页上注明物料名称、批号、分析员签名和日期 All analytical data must be recorded including failed or abandoned analysis. An explanation must be given for why the analysis failed or was abandoned. 必须记录所有分析数据，包括失败或作废的分析在内，但这种情况下必须给出失败或作废的理由 Spaces shall not be left blank. A single line or N/A shall be included where no data is required. Use of ditto marks (--) for repeated entries is prohibited.原始记录及报告空白处应注上“N/A”或单线划去不得以“--”代替重复书写The use of post-it notes for recording of analytical data is forbidden. Loose-leaf records must be systematically collected.禁止使用随意贴记录分析数据。

散页记录必须系统性地收集成册After all tests have been finished, the primary record should be reviewed by another lab staff. The data review includes legibility, completeness, accuracy, consistency of the original records, calculation, conformance to specifications, etc. 所有测试完成后，由另一位实验室人员审核原始记录数据审核同时包括将结果与质量标准进行比较复核内容包括：原始记录是否清晰，完整，准确，前后一致，计算是否正确，结果是否符合标准等Details of reporting of analytical results refer to SOP_QC010 “Rounding and Reporting of Analytical Results”. For other recording requirements, refer to SOP_QA002 “Documentation Management”. 分析结果的报告具体参见SOP_QC010 “分析结果的修约与报告”。

其他有关记录的要求请参阅SOP_QA002 “文件的管理”Testing reports (Annex 4 Testing report template) should be issued immediately after SOP_QC003 v1.0 Laboratory Record Management 实验室记录管理Page 4 of 10the testing. QC lab is responsible to inform representatives of relevant departments. COA (Annex 5 COA template) should also be issued by QC and approved by QA for released product.实验完成后应立即出具测试报告(附件4测试报告模版)QC实验室负责通知相关部门的代表对于放行的产品由QC另外出具COA（附件5 COA模版）后由QA批准Raw data, laboratory records and reports must be securely stored and/or archived for specified time periods, under appropriate conditions to ensure their integrity, and allows for easy retrieval and review, e.g. testing report and the relevant testing record of different materials will be archived in QC lab. 定期在合适条件下对原始数据、实验室记录和报告进行安全储存和归档，以保证其完整性和有效地追溯和审核，如：根据不同的物料，测试报告和相关测试记录由QC统一归档管理。

5 Responsibilities 职责:QC is responsible for QC的职责为: Record what was done and the results obtained in a timely manner及时记录测试行为和结果 Issue and review testing report and COA 出具并审核测试报告和 COA  Ensure test is recorded according to cGMP requirement保证记录符合 cGMP的要求 QA is responsible for QA的职责为: Control distribu。