CGMP文件 回收溶媒的取样及批准程序SOP

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

2、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 sam

3、pling 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:After receiving the Request for Sampling and Analysis Slip from production for complete analysis of recovered solvent, QC anal

4、yst should make an entry in the respective Recovered Solvent Inward Register and assign an A. R No.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 samp

5、le identification labels to the sample bottle.检验员要穿戴必需的防护服。The analyst should wear necessary personnel protective equipment.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.Col

6、lect 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.After collecting sample, QC analyst should paste Sampled label indicating the relevant details of the solvent on

7、all drums from which samples are taken.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.The QC analyst/Production personnel should ensure that the d

8、rums 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 SolventsAfter drawing the sample as per sampling procedure described above, the QC analyst should carry out analysis as per respective standard test procedure.The QC a

9、nalyst should enter all the calculations and other raw data in respective work book.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 Regist

10、er.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.For all the recovery solvents retest date will be allotted for one year. If the recovered solvent fails to conform with respect to specifica

11、tions, the solvent should be rejected and rejected labels should be pasted on all drums.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

12、验报告单回收溶媒(Annexure IAnalytical Report Recovery Solvent (Annexure I6.3 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

13、/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 Parameter结果Results标准Specifica