欧盟工艺验证报告(中英文翻译)

BAFNA PHARMACEUTICALSLIMITEDPage1 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 PROCESS VALIDATIONSUMMARYREPORT 工艺验证总结报告 FOR MANUFACTURINGPROCESS OF Paracetamol tablets 500 mg 对乙酰氨基酚 500mg片生产工艺 BAFNA PHARMACEUTICALSLIMTEDPage2 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 The listed review and approval signaturesindicate the approval of the validation results. 以下审核和批准签字表示批准验证结果。 VALIDATIONREPORT APPROVAL 验证报告批准 Activity 活动 Name 姓名 Designation 职务 Department 部 门 Signature 签 字 Date日 期 Prepared By 制 定 PRAKASH.K.CExecutive主 管 Quality Assurance QA Reviewed By 审 核 AMARESH.C Manager经理Production生 产 Reviewed By 审 核 RAVI CHANDRAN.N.R Manager经理 Quality Control质控 Reviewed By 审 核 JAYANTHA.T General Manager总经 理 Technical技 术 Reviewed By 审 核 RAGHAVENDRAN.V Deputy Manager副经 理 Quality Assurance QA Approved By 批 准 DHAYALASEKARM.N Manager经理 Quality Assurance QA BAFNA PHARMACEUTICALSLIMTEDPage3 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 INDEX FORMATPAGE NO.NO.OF PAGES Processvalidation Summary report cover sheet.工艺验证总结报告封面页11 Validation Report Approval 验证报告批准21 Index引言31 Introduction 简介41 References参考41 Batch References批参考 41 Validation of Dry mixing and Granulation 干混和制粒确证5 - 62 Validation of Drying Process干燥过程确证71 Validation of Blending Process混合过程确证8 - 103 Validation of Lubrication Process润滑过程确证 11 - 144 Validation of Compression Process压缩过程确证15 - 2410 Worst casestudy of Tablet Hardness硬度最差情况研究25 - 262 Impact study of power failure in compression process压片过程电力故障影响研究27 - 282 Comparison of in processresults with quality control results质量控制的过程比较结 果 291 End of compression results asper Finished Product Specification 压片结束结果30 334 Reject classification 不合格分类341 Validation final conclusion 确证最后结论 351 BAFNA PHARMACEUTICALSLIMTEDPage4 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 1.0INTRODUCTION简介 This report summarizes theresults of processvalidation performed for Batch No. 907001, 907002, and 907003 of Batch size 0.5 M tablets asper ProcessValidation Protocol No.PVP: B08005 / 0.5M / 00. 报告总结验证数据的批号为907001, 907002,907003和批量 50万片 2.0REFERENCES 参考文献 The batch wasmanufactured and analysedasper following documents.批生产和检验相关文件 1 Master Formula Record 主要处方记录 Doc. No. MFR: B08005 / 0.5M / 00 2 Batch Manufacturing Record 批生产记录 Doc. No. BMR: B08005 / 0.5 M / 00 3 Finished Product Specification 成品规格 Doc. No. FPS:F08005. 3.0BATCH REFERENCE 批参考 Paracetamol tablets 500mg Paracetamol tablets 500 mgParacetamol tablets 500 mg Batch No批号 .: 907001Batch No. 批号: 907002Batch No批号.: 907003 Mfg. Date生产日期 : July. 2009Mfg. Date生产日期 : July. 2009Mfg. Date生产日期 : July. 2009 Exp. Date有效日期 : June.2012Exp. Date有效日期 : June.2012Exp. Date有效日期 : June.2012 Batch size批量: 5,00,000 TabletsBatch size批量 : 5,00,000 TabletsBatch size批量: 5,00,000 Tablets BAFNA PHARMACEUTICALSLIMTEDPage5 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 4.0 VALIDATIONOF DRYMIXINGAND GRANULATIONPROCESS: 干混、制粒工序验证 Thevalidation wasdoneasper point no. 12.3 of Validation Protocol. ThesiftedParacetamol BP/Ph.Eur,PregelatinisedmaizestarchBP/Ph.Eur(Pregelatinised Starch) andMaize StarchBP/Ph.Eur areloadedinto RMG andDry mixing is carried out for 10,15 and 20 minutes at slowspeed.Sampleswerewithdrawnfrom5differentpositionsofRMG and analyzed forassay of Paracetamol. Sampling wascarriedout asper point No. 15.0 and16.0 (a) of thevalidation protocol. 按照验证方案 12.3进行确证。 过筛后的对乙酰氨基酚，预胶化玉米淀粉和玉米淀粉加载到RMG中，低速干混 10,15和20分钟。 样品从RMG中5个不同位置抽取分析对乙酰氨基酚含量。按照方案中15、16进行取样。 Assay of Paracetamol对乙酰氨基酚含量分析 :(Limit: NLT 95.0 % andNMT 105.0% / 95.0105.0%(475.00mg to 525.00mg) RSD: Not morethan 2.0%. Batch No批号. 907001(Lot - I) (10 Minutes)A.R.NO.: BPV 90066 Sample Location 样品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Mean 平均 RSD% Assay in mg 493.3497.5496.0497.8496.1496.10.36 % Assay in %98.799.599.299.699.299.20.36 % Batch No. 907001(Lot - II) (10 Minutes)A.R.NO.: BPV 90068 Sample Location 样 品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Mean 平均 RSD% Assay in mg501.4499.6496.5496.8502.2499.30.52 % Assay in % 100.399.999.399.4100.499.90.52 % Batch No. 907001(Lot - III) (10 Minutes)A.R.NO.:BPV90070 Sample Location样 品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Mean 平均 RSD% Assay in mg495.1501.3496.7499.6497.9498.10.49 % Assay in %99.0100.399.399.999.699.60.49 % BAFNA PHARMACEUTICALSLIMTEDPage6 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 批号Batch No. 907001(Lot - I) (15 Minutes15分钟)A.R.NO.: BPV 90066 Sample Location 样 品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Top 顶部 RSD% Assay in mg499.6501.8495.4500.4498.1499.10.49 % Assay in %99.9100.499.1100.199.699.80.49 % 批号Batch No. 907001(Lot - II) (15 Minutes 分钟)A.R.NO.: BPV 90068 Sample Location 样 品位置 TopMiddle LeftMiddleMiddle RightBottomMeanRSD% Assay in mg492.7503.8501.8491.9498.5497.81.07 % Assay in %98.5100.8100.498.499.799.61.07 % 批号Batch No. 907001(Lot - III) (15 Minutes)A.R.NO.: BPV 90070 Sample Location 样 品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Top 顶部 RSD% Assay in mg495.8495.9501.7498.3498.4498.00.48 % Assay in %99.299.2100.399.799.799.60.48 % 批号Batch No. 907001(Lot - I) (20 Minutes)A.R.NO.: BPV 90066 Sample Location 样 品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Top 顶部 RSD% Assay in mg 494.5503.9495.9489.1493.6495.41.08 % Assay in %98.9100.899.297.898.799.11.08 % 批号Batch No. 907001(Lot - II) (20 Minutes)A.R.NO.: BPV 90068 Sample Location 样 品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Top 顶部 RSD% Assay in mg505.4495.9496.6499.3499.4499.30.76 % Assay in % 101.199.299.399.999.999.90.76 % 批号Batch No. 907001(Lot - III) (20 Minutes) A.R.NO.: BPV 90070 Sample Location 样 品位置 Top 顶部 Middle Left 中左 Middle 中部 Middle Right 中右 Bottom 底部 Top 顶部 RSD% Assay in mg491.3499.4491.6498.2499.4496.00.84 % Assay in %98.399.998.399.699.999.20.84 % Conclusion 结论 :From the assayof Paracetamolof the samples,withdrawn from different location and different intervalsofRapidMixergranulator.TheAverageRSDobtainedofthree consecutive Lotsformixing time.10 minutesis 0.46 %, mixing time of 15 minutes is 0.68 % and mixing time of 20 minutes is 0.89 %. 通过在不同时间段对不同位置取样，检验对乙酰氨基酚的含量，连续三锅的平均RSD为：10分钟是 0.46 %,混合15分钟是 0.68 %，混合 20分钟是 0.89 %。 All the threemixing times averageRSD is well within the acceptancecriteria but mixing time of 10 minutes RSD is lowest and it can beconcludedthat at the slow speedof Impeller, mixing time of 10 minute is most adequateto obtain uniform mix with respectto drugcontent. 所有三个时间段的平均RSD都在可接受范围内，但混合10分钟， RSD最低，得出结论低速混合10分 钟对于药品含量均一性是最适合的。 BAFNA PHARMACEUTICALSLIMTEDPage7 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 5.0 VALIDATIONOF DRYING PROCESS干燥过程验证 : Validation of drying processwas performed to establish thedrying time. 通过对干燥工序进行验证确认干燥时间 The validation was carried out asper point no 12.4 of processvalidation protocol. 按照验证方案 12.4进行验证 Drying was carried out in Fluid Bed Dryer. The wet-massare loaded into FBD Bowl from RMG anddried at 50 60Cinlet temperature,30 40Coutlet temperature,and 15 40 % flap position untill it reachLOD Limit (1.6 to 2.1%),Target value 1.8 to 2.0%. Sampling was carried out asper point No. 15.0 and 16.0 (b) of the processvalidation protocol. 在流化床沸腾干燥器进行干燥。将湿品从RMG 转入 FBD 中，并在送风温度为50 60C ，排风温度为30 40C ，阀门 的开口为15 40 %干燥，直到达到LOD 限度（ 1.6到2.1%）（目标值为 1.8到2.0%） 按照验证方案15和16，进行取样。 LOD 干燥失重Acceptance Criteria 可以接受标准 Batch No.批号 90700 Limit 限度 : 1.6 to 2.1% Target value/目标值： 1.8 to 2.0%. Lot No. 锅 Lot-ILot-IILot-III Sampling 取样点 Top顶层 1.93 %1.81 %1.86 % Middle Left/ 中间靠左 1.98 % 1.78 %1.92 % Middle Centre/中间中心 2.04 % 1.86 %1.80 % Middle Right/中间靠右 1.90 % 1.85 %1.85 % Bottom/底部 1.84 % 1.91 %1.76 % Average/ 平均 1.93 % 1.84 %1.83 % A.R.NO/ 检验报告单号BPV 90067BPV 90069BPV 90071 47 minutes45 minutes45 minutesTo be established Total DryingTime 总干燥时间 Inlet Temperature 进风温度 53 54C54 55C53 54C50 60C Outlet Temperature 排风温度 26 28C27 28C27 28C30 40C Flap position 阀门位置 25 % 25 %25 %15 40 % Conclusion 结论 : From the LOD of dried granulesof the samples,withdrawn from different location of FBD bowl, the averageLOD obtained for three consecutiveLots is 1.93% , 1.84 % and 1.83 %andhenceit canbe concludedthat drying time 40 50 minutes.is adequateto obtainuniform dried granules 通过在不同位置取样，检验样品颗粒的干燥失重。连续三锅的平均干燥失重为：1.93% , 1.84 % and 1.83 %，所以干燥 40-50分钟能够得到干燥均匀颗粒。 BAFNA PHARMACEUTICALSLIMTEDPage8 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 7.0 VALIDATIONOF BLENDINGPROCESS: 混合过程验证 Thevalidation wasdoneasper point no. 12.5 of Validation Protocol. 按照方案 12.5进行验证 TheSizedgranules,Dried maizestarchBP/Ph.Eurareloadedinto OctagonalBlender andblending was carriedout for 15, 17 and19 minuteskeepingthe OctagonalBlenderRPM at. Sampleswere withdrawn from 10different positionsof OctagonalBlender andanalyzedfor assayof Paracetamol. Sampling wascarriedout asper point No. 15.0 and16.0(c) of thevalidation protocol. 将整完粒的颗粒，干玉米淀粉加入到八角混合机中，8 RPM混合15、17、19分钟。从八角混合 机的10个不同部位取样，测定对乙酰氨基酚的含量。 按照方案 15.0、16.0进行取样 Assay of Paracetamol:(Limit: NLT 95.0 % andNMT 105.0% (475.00 mg to 525.00mg) 对乙酰氨基酚含量： RSD: Not morethan 2.0%. 批号Batch No. 907001(15 Minutes)A.R.NO.: BPV 90072 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 498.0492.2504.4506.3511.2496.9506.5499.7508.5496.7502.01.23 % Assay 含量百 分比in%99.698.4100.9101.3102.299.4101.399.9101.799.3100.41.23 % 批号Batch No. 907002(15 Minutes)A.R.NO.: BPV 90074 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 498.5507.1493.7506.1504.7502.3500.4506.1493.8501.2501.40.97 % Assay 含量百 分比in%99.7101.498.7101.2100.9100.5100.1101.298.8100.2100.30.97 % 批号Batch No. 907003* (15 Minutes)A.R.NO.: BPV 90080 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 490.9505.6500.1496.8501.6501.1491.0511.8506.6507.5501.31.38 % Assay 含量百 分比in%98.2101.1100.094.4100.3100.298.2102.4101.3101.5100.31.38 % BAFNA PHARMACEUTICALSLIMTEDPage9 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 批号Batch No. 907001(17 Minutes)A.R.NO.: BPV 90072 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 513.3507.5487.1494.7504.4487.0508.9489.4509.7504.6500.72.02 % Assay 含量百 分比in%102.7101.597.498.9100.997.4101.897.9101.9100.9100.12.02 % 批号Batch No. 907002(17 Minutes)A.R.NO.: BPV 90074 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 500.4499.7504.0483.0496.8495.3504.8501.9500.3492.2497.81.30 % Assay 含量百 分比in%100.199.9100.896.699.499.1101.0100.4100.198.499.61.30 % 批号Batch No. 907003* (17 Minutes)A.R.NO.: BPV 90080 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 502.9508.0501.9496.3497.2507.3508.2494.0502.1497.0501.51.04 % Assay in % 100.6101.6100.499.399.4101.5101.698.8100.499.4100.31.04 % 批号Batch No. 907001(19 Minutes)A.R.NO.: BPV 90072 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 493.0503.5496.5490.8501.9498.6497.1506.8491.6504.7498.51.13 % Assay 含量百 分比in%98.6100.799.398.2100.499.799.4101.498.3100.999.71.13 % 批号Batch No. 907002(19 Minutes)A.R.NO.: BPV 90074 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 494.8501.2498.8500.1498.4501.7500.8491.3497.0497.5498.20.65 % Assay 含量百 分比in%99.0100.299.8100.099.7100.3100.298.399.499.599.60.65 % 批号Batch No. 907003* (19 Minutes)A.R.NO.: BPV 90080 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay含量 in mg 501.9499.4499.5495.1501.2493.2504.0499.3500.9500.1499.50.63 % Assay 含量百 分比in%100.499.999.999.0100.298.6100.899.9100.2100.099.90.63 % BAFNA PHARMACEUTICALSLIMTEDPage10 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 Conclusion结论: Fromtheassay ofParacetamolofthesamples, withdrawnfromdifferentlocation anddifferent intervalsofOctagonalBlender,TheAverageRSDobtainedofthree batchesformixingtime.15 minutes is 1.19 %, mixing time of 17 minutes is 1.45 % and mixing time of 19 minutes is 0.80 %. All the threemixing times averageRSD is well within the acceptancecriteria but mixing time of 19 minutes RSD is lowest and it can be concluded that at the set OctagonalBlender RPM of 8, mixing time of 19minute is mostadequateto obtainuniform mix with respectto drug content. 通过在不同时间段不同位置取样，检测对乙酰氨基酚的含量，得到三个批次不同混合时间的 平均RSD值：15分钟是 1.19%，17分钟是 1.45%，19分钟是 0.80%。 所有三个混合时间的平均RSD是在可接受范围内，但是19分钟 RSD最低，由此得出结论： 8RPM混合19分钟将药品含量的均匀度达到最佳。 BAFNA PHARMACEUTICALSLIMTEDPage11 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 7.0 VALIDATIONOF LUBRICATIONPROCESS:润滑过程的验证 Validationoflubricationprocess wasperformedtoinvestigatetheblenduniformity, descriptionof blend, bulk density, tappeddensity,LOD andparticle sizedistribution. 润滑工序是通过确认混合均一度，外观，堆密度，松密度，LOD和粒径分布进行验证的。 Lubrication wascarried out asperpoint no. 12.6 of Validation Protocol. 润滑按照验证方案 12.6条进行验证 Lubrication of the granuleswascarried out in Octagonalblender. 在八角混合机中，润滑颗粒 Thelubricant i.e.StearicacidBP /Ph.Eurwasaddedto lubricate granulesin the Octagonalblender.The sampleswere withdrawn from 10 different positions of OctagonalBlender after lubrication of 02, 03 and 04minutes keepingBlender RPM as8 andanalysedfor assayof Paracetamol.Onecompositesampletaken from top, middle andbottom of OctagonalBlender andanalysedfor description of blend, bulk density, tappeddensity,LOD andparticle sizedistribution. After unloading theblend, sampleswere takenfrom threecontainers(compositeof top, middle andbottom) andanalysedfor assayof Paracetamol. Sampling wascarriedout asper point No. 15.0 and16.0 (c andd) of the validation protocol. 将润滑剂硬脂酸加入到八角混合机中，8 RPM润滑2、3、4分钟后，分别从八角混合机10 个不同位置取样，检测含量。取一个混合样：从八角混合机的上部，中部，底部取样，确 定外观，堆密度，松密度，LOD和粒径分布。卸料后，从三个容器中取样，检测对乙酰氨 基酚含量 Assayof Paracetamol:(Limit: NLT 95.0 % andNMT 105.0% (475.00 mg to 525.00mg) RSD: Not morethan 2.0%. 按照验证方案 15.0、16.0进行取样。检测对乙酰氨基酚含量（限度：NLT 95.0 % 和NMT 105.0% (475.00 mg 到 525.00mg)）RSD:不超过 2.0%。 批号Batch No. 907001(02 Minutes)批号907001（02分钟）A.R.NO.: BPV 90073 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 492.5504.3494.2505.5505.3500.1487.0488.8508.1486.4497.21.69 % Assay in % 98.5100.998.8101.1101.1100.097.497.8101.697.399.4 1.69 % 批号Batch No. 907002(02 Minutes)A.R.NO.: BPV 90075 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 503.6503.2509.4496.7494.2496.4495.9501.5507.6501.6501.01.03 % Assay in % 100.7100.6101.999.398.899.399.2100.3101.5100.3100.21.03 % 批号Batch No. 907003* (02 Minutes)A.R.NO.: BPV 90081 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 500.6494.0504.3490.3503.2501.8495.4513.8507.8504.2501.51.38 % Assay in % 100.198.8100.998.1100.6100.499.1102.8101.6100.8100.31.38 % BAFNA PHARMACEUTICALSLIMTEDPage12 of 35 PROCESS VALIDATIONSUMMARYREPORTDoc No.:PVSR: B08005 / 0.5M / 00 Product Paracetamol tablets 500 mg Ref.Protocol No.:PVP: B08005 / 0.5M / 00 批号Batch No. 907001(03 Minutes)A.R.NO.: BPV 90073 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 502.8508.2495.9497.6508.9512.9510.0500.3496.4501.3503.41.22 % Assay in % 100.6101.699.299.5101.8102.6102.0100.199.3100.3100.71.22 % 批号Batch No. 907002(03 Minutes)A.R.NO.: BPV 90075 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 496.0493.8505.9495.6498.0503.8506.4501.6506.2504.6501.20.98 % Assay in % 99.298.8101.299.199.6100.8101.3100.3101.2100.9100.20.98 % 批号Batch No. 907003* (03 Minutes)A.R.NO.: BPV 90081 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 509.1501.9497.2491.2492.5508.2504.9504.0492.4497.4499.91.33 % Assay in % 101.8100.499.498.298.5101.6101.0100.898.599.5100.01.33 % 批号Batch No. 907001(04 Minutes)A.R.NO.: BPV 90073 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 505.4497.3494.1499.8501.0504.1498.3501.9505.9498.2500.60.76 % Assay in % 101.199.598.8100.0100.2100.899.7100.4101.299.6100.10.76 % 批号Batch No. 907002(04 Minutes)A.R.NO.: BPV 90075 Sample Location 样品位置 TCL 顶部左中 TC 顶部中心 TCR 顶部右中 MBL 中间左后 MBC 中间中后 MBR 中间右后 BFL 底部左前 BFC 底部中前 BFR 底部右前 DP 放料口 Mean 平均 RSD % Assay in mg 500.1496.3502.2504.7498.7499.8497.2496.0501.7498.4499.50.55 % Ass