CGMP文件-回收溶媒的取样及批准程序SOP.doc

精品文档标准操作程序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4页Page No.: 1 of 4标题：回收溶媒取样及放行程序TITLE: PROCEDURE FOR SAMPLING AND APPROVAL OF RECOVERED SOLVENTS1.0目的 Purpose:描述回收溶媒的取样及放行的程序。Describe the procedure to be followed for the sampling and approval of recovered solvents.2.0范围 Scope:本程序适用于不同产品生产过程中各个阶段所得到的回收溶媒。This procedure applies to solvents recovered from all stages of different products during their manufacturing process.3.0定义 Definitions: 无Nil4.0职责 Responsibility:QC检验员以上职位的人员负责回收溶媒的取样及分析。The responsibility of sampling and analysis of the recovered solvents lies with the staff of cadre not lower than QC analyst.5.0程序 Procedure :5.1 回收溶媒取样的程序 Procedure for Sampling Recovered Solvents:5.1.1当收到生产部门回收溶媒全检的“请验单”后，QC检验员应在各自的QC来样登记本中登记并编制检验报告单号。After receiving the Request for Sampling and Analysis Slip from production for complete analysis of recovered solvent, QC analyst should make an entry in the respective Recovered Solvent Inward Register and assign an A. R No.5.1.2 QC 检验员带上取样工具到回收溶媒存放地点进行取样，取样证需贴在桶上，同时在样品瓶上贴上识别标签。QC analyst should proceed to concerned area where the recovered solvent stored with sampling devices, attach the Sampled labels to drums and attach sample identification labels to the sample bottle.6欢迎下载。精品文档5.1.3 检验员要穿戴必需的防护服。The analyst should wear necessary personnel protective equipment.5.1.4 核对回收溶媒桶上标签的名称与批号，应与“请验单”上的相一致。Check the label on the recovered solvent drum for the name of the recovery solvent and batch No. as per Request for Sampling and Analysis Slip.5.1.5假如回收溶媒装有多桶的话，需用洁净且干燥的液体取样器分别从各桶取样。如发现外观异常，应单独取样。Collect sample from all drums if recovered solvent stored in drums with a cleaned and dried liquid sampling devices. If appearance found abnormal, the individual samples should be collected.5.1.6取样后，QC检验员需在所有被取样的桶上贴上取样证，并在取样证上注明该溶媒的相关的信息。After collecting sample, QC analyst should paste Sampled label indicating the relevant details of the solvent on all drums from which samples are taken.5.1.7在一个1L的样品瓶中将样品充分混合以得到一个混合样，在瓶上贴上标签注明样品信息。从中倒出250ml以供分析检验。Mix the collected samples thoroughly in a 1-liter sample bottle to make a composite sample and fix label on sample bottle indicating the sample details. Take 250ml of the mixed sample for the analysis.5.1.8QC检验员/生产人员需确保被打开取样的桶在取样完成后旋紧。The QC analyst/Production personnel should ensure that the drums opened for sampling are closed properly after the activity has been completed.5.2 回收溶媒的放行程序 Procedure for Approval of Recovered Solvents5.2.1在按上述取样程序进行取样后，QC检验员需根据相应的标准检验规程进行样品分析。After drawing the sample as per sampling procedure described above, the QC analyst should carry out analysis as per respective standard test procedure.5.2.2QC检验员需将所有的计算以及其他的原始数据登记在相应的“原始记录本”上。The QC analyst should enter all the calculations and other raw data in respective work book.5.2.3假如该回收溶媒符合所有的测试项目，QC检验员按分析结果出具相应的“检验报告单”，如Annexure-I 所示。并将详细的信息填在相应的来样登记本上。If the recovery solvent conforms all tests, the QC analyst should compile the results in the respective Analytical Report as shown in Annexure I and enter the details in the respective Recovered Solvent Inward Register.5.2.4 检验员要准备合格证并将其贴在装有该溶媒的所有的桶上。QC相关负责人或其他轮班的检验员可以放行该回收溶媒。The QC analyst should prepare Approved labels and paste it on all the drums of the solvent. In charge QC or shift analyst will release the recovered solvent.5.2.5所有回收溶媒的复验期均规定为1年。For all the recovery solvents retest date will be allotted for one year. 5.2.6假如该回收溶媒不符合标准，该溶媒将被拒收。不合格证应贴到每一桶上。If the recovered solvent fails to conform with respect to specifications, the solvent should be rejected and rejected labels should be pasted on all drums.5.2.7 QC检验员将“检验报告单”的复印件分发给相关生产车间一份，原件存档于QC。In-charge QC sends a copy of Analytical Report to concerned production workshop and the original is filed in QC.6.0 相关文件 Related Documents: 6.1 QC来样登记本QC Inward Register 6.2 检验报告单回收溶媒(Annexure I)Analytical Report Recovery Solvent (Annexure I)6.3 合格证Approved Label 6.4 不合格证Rejected Label 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精品文档附录IANNEXURE-I分析报告单（回收溶媒）RECOVERY SOLVENT ANALYTICAL REPORT参照文件编码Doc. Ref. No.: SOP/QC/GEN/006 表格号Form No.: FM-QC-049-01生效日期Effective Date:第1页共1页Page 1 of 1 样品名称Material Name:重量 Quantity :批号Batch. No.:生产日期 Mfg. Date :总件数No. of Containers Received:外观检查 Visual inspection. :取样件数No. of Containers Sampled:标准和检验规程号STP No.:取样日期Sampled on:检验报告单号A. R. No.:取样数量Sampled Qty.:检验日期Analysis completed date :收到日期Date of Receipt:复检日期Retest Date:报告REPORT序号Sr.No检验项目Test P