某公司产品质量回顾分析报告模版

2012年度产品质量回顾分析报告回顾期限：2011年12月－2012年11月编号：ZLHG-BX-2012起草QA签名：时间：生产部经理签名：时间：研发部经理签名：时间：审核物控部经理签名：时间：设备部经理签名：时间：质量部经理签名：时间：生产负责人签名：时间：批准质量负责人签名：时间：目录一、基本情况概述二、生产和质量控制情况分析评价1、产品质量标准2、产品质量回顾3、生产分析4、质量事故回顾5、偏差回顾6、超常超标回顾7、稳定性试验8、公用系统、设施设备情况9、变更控制回顾10、委托生产情况回顾11、委托检验情况回顾12、不良反应13、产品退货14、投诉15、产品召回16、药品注册相关变更的申报、批准与退审三、结论一、基本情况概述1概要：根据2010版GMP要求，结合《产品年度质量回顾分析标准操作规程》（SOP-ZL-QA-014）的规定，对 进行产品质量回顾分析。本报告抽取在回顾期限所有放行批次的基础上重点对该品种进行了统计和趋势分析。2回顾期限：2011年12月1日~2012年11月30日。3生产情况：本回顾年度共放行 药材细粉118批， 成品105批，总产量为503585（盒），平均收率为95.92%（按放行产量统计）。生产中严格按照工艺规程与标准操作规程的要求组织生产,经粉碎、总混、泛丸、干燥、包衣、干燥、选丸、打光、包、外包等工序，完成生产。4规格与包装规格：-包装：-5有效期与贮藏5.1有效期：24个月。贮藏：密闭，防潮。6产品特点性状：-功能主治：：-用法用量：-7处方与批量8处方依据8.1批准文号质量标准依据：---制剂每次投料量： 9生产工艺流程

检验检验二、生产和质量控制情况分析1产品质量标准1.1药材细粉质量标准项目名称控标准法定标准性状细度细菌数微生霉菌和酵母菌数物限大肠菌群度大肠埃希菌活螨1.2成品质量标准项目名称控标准法定标准性状鉴别检查水分装量差异溶散时限细菌数霉菌和酵母菌数大肠菌群大肠埃希菌活螨2产品质量回顾2.1原辅料购进情况回顾

原辅料供应商入库批次评价：本回顾年度，供应商质量管理均按相关文件严格执行，供应商质量管理的风险处于可控状态。2.2原辅料质量问题回顾物料名称供应商不合格批次不合格项目原因处理意见//////评价：本回顾年度购进的原辅料均符合质量标准。2.3包装材料质量问题回顾物料名称供应商不合格批次不合格项目原因处理意见//////评价：本回顾年度购进的包装材料均符合质量标准。2.4中间产品质量回顾本回顾年度生产的 药材细粉所有批次的性状、细度、微生物限度的检验结果均符合控标准（检验结果详见QC检验报告书），合格率达到100%,可以认为在此工艺条件下生产的产品均能达到产品的质量标准。2.5成品质量回顾我们对本回顾年度生产的 成品所有批次进行统计和趋势分析。2.5.1 成品性状、鉴别、水分、装量差异、溶散时限、微生物限度、含量检验结果的统计数据（检测结果来源于该批QC检验报告书）。111201符合规定符合规定3.8符合规定26符合规定8.03.9111202符合规定符合规定2.9符合规定33符合规定6.34.0111203符合规定符合规定4.6符合规定25符合规定7.34.4

111204符合规定符合规定3.7符合规定26符合规定7.64.7111205符合规定符合规定3.6符合规定25符合规定6.63.8111206符合规定符合规定3.5符合规定26符合规定7.14.2120101符合规定符合规定3.9符合规定26符合规定8.04.0120102符合规定符合规定3.9符合规定25符合规定7.03.9120201符合规定符合规定3.5符合规定32符合规定6.33.9120202符合规定符合规定4.5符合规定26符合规定9.44.6120203符合规定符合规定5.0符合规定34符合规定7.44.3120204符合规定符合规定4.3符合规定35符合规定7.14.4120205符合规定符合规定3.2符合规定32符合规定8.05.2120206符合规定符合规定3.6符合规定33符合规定8.14.2120207符合规定符合规定4.1符合规定26符合规定7.33.8120301符合规定符合规定4.1符合规定26符合规定6.64.5120302符合规定符合规定4.0符合规定33符合规定7.13.9120303符合规定符合规定4.7符合规定35符合规定5.54.2120304符合规定符合规定4.4符合规定25符合规定6.44.6120305符合规定符合规定3.4符合规定35符合规定7.33.8120306符合规定符合规定3.1符合规定25符合规定5.84.7120307符合规定符合规定4.1符合规定26符合规定7.14.9120308符合规定符合规定4.1符合规定26符合规定5.94.2120309符合规定符合规定3.2符合规定26符合规定6.14.8120310符合规定符合规定3.3符合规定26符合规定4.44.3120311符合规定符合规定3.8符合规定30符合规定4.74.4120312符合规定符合规定4.5符合规定26符合规定4.84.5120601符合规定符合规定4.2符合规定25符合规定6.64.4120602符合规定符合规定3.4符合规定26符合规定7.04.6120603符合规定符合规定5.1符合规定30符合规定7.55.2120604符合规定符合规定4.3符合规定30符合规定6.54.4120605符合规定符合规定4.2符合规定30符合规定6.94.6120606符合规定符合规定4.1符合规定30符合规定8.24.6

120607符合规定符合规定4.9符合规定26符合规定7.04.6120608符合规定符合规定4.1符合规定26符合规定6.64.5120701符合规定符合规定3.6符合规定25符合规定7.23.8120702符合规定符合规定3.6符合规定26符合规定7.14.2120703符合规定符合规定3.8符合规定30符合规定7.34.2120704符合规定符合规定3.4符合规定30符合规定7.24.0120705符合规定符合规定4.3符合规定25符合规定8.94.8120706符合规定符合规定3.5符合规定30符合规定9.74.7120707符合规定符合规定3.8符合规定30符合规定7.95.1120708符合规定符合规定4.1符合规定30符合规定8.45.1120709符合规定符合规定3.9符合规定30符合规定7.25.2120710符合规定符合规定3.6符合规定25符合规定8.95.2120711符合规定符合规定4.3符合规定25符合规定7.35.7120712符合规定符合规定4.8符合规定26符合规定6.95.3120801符合规定符合规定3.9符合规定29符合规定7.45.4120802符合规定符合规定4.0符合规定29符合规定7.25.4120803符合规定符合规定4.8符合规定30符合规定9.55.7120804符合规定符合规定4.0符合规定30符合规定8.85.7120805符合规定符合规定4.5符合规定20符合规定7.95.0120806符合规定符合规定4.8符合规定26符合规定8.14.7120807符合规定符合规定4.5符合规定28符合规定7.85.0120808符合规定符合规定4.6符合规定20符合规定7.24.9120809符合规定符合规定4.2符合规定25符合规定8.55.6120810符合规定符合规定3.2符合规定25符合规定9.14.6120811符合规定符合规定3.4符合规定29符合规定8.94.4120812符合规定符合规定4.0符合规定25符合规定8.24.4120813符合规定符合规定4.1符合规定25符合规定7.74.6120814符合规定符合规定4.4符合规定26符合规定6.54.6120815符合规定符合规定4.4符合规定25符合规定7.04.6120816符合规定符合规定3.7符合规定23符合规定6.74.1

120817符合规定符合规定4.4符合规定26符合规定7.74.9120818符合规定符合规定4.7符合规定26符合规定8.35.4120819符合规定符合规定3.5符合规定26符合规定9.25.6120820符合规定符合规定4.2符合规定25符合规定8.55.1120821符合规定符合规定4.4符合规定26符合规定8.95.2120822符合规定符合规定4.0符合规定27符合规定9.55.7120901符合规定符合规定4.8符合规定25符合规定8.05.6120902符合规定符合规定3.7符合规定24符合规定9.05.0120903符合规定符合规定5.1符合规定26符合规定9.05.5120904符合规定符合规定4.1符合规定36符合规定9.45.4120905符合规定符合规定4.1符合规定38符合规定9.84.7120906符合规定符合规定3.9符合规定40符合规定8.94.9120907符合规定符合规定4.8符合规定25符合规定9.64.6120908符合规定符合规定4.4符合规定30符合规定8.64.6120909符合规定符合规定3.7符合规定20符合规定9.45.0120910符合规定符合规定4.6符合规定28符合规定8.24.6120911符合规定符合规定3.6符合规定26符合规定10.14.8120912符合规定符合规定3.3符合规定28符合规定9.84.9121001符合规定符合规定3.2符合规定20符合规定9.94.9121002符合规定符合规定3.8符合规定25符合规定10.95.0121003符合规定符合规定4.1符合规定23符合规定8.65.0121004符合规定符合规定3.3符合规定30符合规定10.34.8121005符合规定符合规定3.6符合规定30符合规定11.45.2121006符合规定符合规定4.2符合规定25符合规定9.94.7121007符合规定符合规定4.2符合规定25符合规定8.64.6121008符合规定符合规定4.3符合规定25符合规定9.44.6121009符合规定符合规定4.0符合规定25符合规定8.24.8121010符合规定符合规定3.8符合规定28符合规定8.24.6121011符合规定符合规定3.4符合规定26符合规定8.74.6121012符合规定符合规定3.4符合规定25符合规定8.64.6

12n01符合规定符合规定4.6符合规定20符合规定8.74.412n02符合规定符合规定3.7符合规定28符合规定7.74.2121103符合规定符合规定3.8符合规定25符合规定9.14.212n04符合规定符合规定3.8符合规定28符合规定8.24.6121105符合规定符合规定3.6符合规定25符合规定8.84.0121106符合规定符合规定3.8符合规定25符合规定8.64.5121107符合规定符合规定3.2符合规定26符合规定8.54.5121108符合规定符合规定3.3符合规定30符合规定9.34.4121109符合规定符合规定3.8符合规定25符合规定8.44.7121110符合规定符合规定3.8符合规定20符合规定7.85.0121111符合规定符合规定3.8符合规定26符合规定7.84.8121112符合规定符合规定4.0符合规定25符合规定8.64.62.5.2用 成品水分检验结果绘制控制图。序号数据序号数据序号数据序号数据序号数据X13.8X234.1X453.6X674.2X894.3X22.9X243.2X464.3X684.4X904.0X34.6X253.3X474.8X694.0X913.8X43.7X263.8X483.9X704.8X923.4X53.6X274.5X494.0X713.7X933.4X63.5X284.2X504.8X725.1X944.6X73.9X293.4X514.0X734.1X953.7X83.9X305.1X524.5X744.1X963.8X93.5X314.3X534.8X753.9X973.8X104.5X324.2X544.5X764.8X983.6X115.0X334.1X554.6X774.4X993.8X124.3X344.9X564.2X783.7X1003.2X133.2X354.1X573.2X794.6X1013.3X143.6X363.6X583.4X803.6X1023.8X154.1X373.6X594.0X813.3X1033.8

X164.1X383.8X604.1X823.2X1043.8X174.0X393.4X614.4X833.8X1054.0X184.7X404.3X624.4X844.1//X194.4X413.5X633.7X853.3//X203.4X423.8X644.4X863.6//X213.1X434.1X654.7X874.2//X224.1X443.9X663.5X884.2//计算平均值为元=3.98；计算移动差距R值如下表:新的子群连续的对子移动差距R新的子群连续的对子移动差距R13.82.90.9544.54.60.122.94.61.7554.64.20.434.63.70.9564.23.21.043.73.60.1573.23.40.253.63.50.1583.44.00.663.53.90.4594.04.10.173.93.90.0604.14.40.383.93.50.4614.44.40.093.54.51.0624.43.70.7104.55.00.5633.74.40.7115.04.30.7644.44.70.3124.33.21.1654.73.51.2133.23.60.4663.54.20.7143.64.10.5674.24.40.2154.14.10.0684.44.00.4164.14.00.1694.04.80.8174.04.70.7704.83.71.1184.74.40.3713.75.11.4194.43.41.0725.14.11.0203.43.10.3734.14.10.0

213.14.11.0744.13.90.2224.14.10.0753.94.80.9234.13.20.9764.84.40.4243.23.30.1774.43.70.7253.33.80.5783.74.60.9263.84.50.7794.63.61.0274.54.20.3803.63.30.3284.23.40.8813.33.20.1293.45.11.7823.23.80.6305.14.30.8833.84.10.3314.34.20.1844.13.30.8324.24.10.1853.33.60.3334.14.90.8863.64.20.6344.94.10.8874.24.20.0354.13.60.5884.24.30.1363.63.60.0894.34.00.3373.63.80.2904.03.80.2383.83.40.4913.83.40.4393.44.30.9923.43.40.0404.33.50.8933.44.61.2413.53.80.3944.63.70.9423.84.10.3953.73.80.1434.13.90.2963.83.80.0443.93.60.3973.83.60.2453.64.30.7983.63.80.2464.34.80.5993.83.20.6474.83.90.91003.23.30.1483.94.00.11013.33.80.5494.04.80.81023.83.80.0504.84.00.81033.83.80.0

514.04.50.51043.84.00.2524.54.80.31054.0//534.84.50.3////计算平均移动极差（即这104个值的平均值）=0.498移动极差R控制图绘制：CLR=R=0.498UCLR=D4R=3.27X0.498=1.63LCLR=D3R=0系数4和D4的值按9=2行查表得，由于该移动极差图已呈现出统计控制状态，于是可进行单值控制图的绘图I 4单值X控制图绘制： CLx=X=3.98UCLX=X+E2R=X+2.66R=3.98+2.66X0.498=5.31LCLx=X-E2R=X-2.66R=3.98-2.66X0.498=2.66采用n=2,查表知E2=2.66。该控制图表明过程处于统计控制状态。成品水分R控制图1.81.61.41.21.0D.80.6D.4□.2——CLR0.0——CLR成品水分X控制图6.0-检验结果6.0-检验结果,匚LXUCLX■ICLXDO0T3Eon二Un口WEETED7IKCIGCIEI《昌二5LWW寸TM口r-JTSCISofT—LEmLss^Tcm二50二I-I昌『IECIED7I—IIEIIL.o.G.Q.0.0,0543210(空)朱黑2.5.3用 成品溶 检验结果绘制控制图。序号数据序号数据序号数据序号数据序号数据X126X2426X4726X7025X9325X233X2526X4829X7124X9420X325X2630X4929X7226X9528X426X2726X5030X7336X9625X525X2825X5130X7438X9728X626X2926X5220X7540X9825X726X3030X5326X7625X9925X825X3130X5428X7730X10026X932X3230X5520X7820X10130X1026X3330X5625X7928X10225X1134X3426X5725X8026X10320X1235X3526X5829X8128X10426X1332X3625X5925X8220X10525X1433X3726X6025X8325//X1526X3830X6126X8423//X1626X3930X6225X8530//X1733X4025X6323X8630//

X1835X4130X6426X8725//X1925X4230X6526X8825//X2035X4330X6626X8925//X2125X4430X6725X9025//X2226X4525X6826X9128//X2326X4625X6927X9226//计算平均值为元=27.15;计算移动差距R值如下表:新的子群连续的对子移动差距新的子群连续的对子移动差距1263375428208233258552025532526156252504262515725294525261582925462626059252507262516025261825327612625193226662252321026348632326311343516426260123532365262601332331662625114332676725261152626068262711626337692725217333527025241183525107124262192535107226361020352510733638221252617438402

22262607540251523262607625305242626077302010252630478202882630264792826227262518026282282526181282082926304822025530303008325232313030084233073230300853030033302648630255342626087252503526251882525036252618925250372630490252833830300912826239302559226251402530593252054130300942028842303009528253433030096252834430255972825345252509825250462526199252614726293100263044829290101302554929301102252055030300103202665130201010426251

522026610525//5326282////计算平均移动极差（即这104个值的平均值）=3.106移动极差R控制图绘制：CLr=R=3.106UCLR=D4R=3.27X3.095=10.2LCLr=D3R=0系数口:和4的值按9=2行查表得，由于该移动极差图已呈现出统计控制状态，于是可进行单值控制图的绘图。4单值X控制图绘制：CLx=X=27.15UCLx-X+E2R=X+2.66R=27.15+2.66X3.106=35.4LCLX=X-E2R=X-2.66R=27.15-2.66X3.106=18.9采用n=2,查表知E2=2.66。该控制图表明过程处于统计控制状态成品溶散时限R控制图成品溶散时限X控制图45cclmTcclmT目三□Kim省mETGOEIm.《昌二c-.Lg三寸i二gdkimbo目I■FEET9口glTz三mofl9mLsio二90《MLI—I口ETTT——石蛤站果——石蛤站果一■CLXUCLX一・LCLXo5Q5O5Q5O4332211w后)援fe室使2.5.4用 成品 含量检验结果绘制控制图。序号数据序号数据序号数据序号数据序号数据X18.0X246.1X476.9X708.0X938.6X26.3X254.4X487.4X719.0X948.7X37.3X264.7X497.2X729.0X957.7X47.6X274.8X509.5X739.4X969.1X56.6X286.6X518.8X749.8X978.2X67.1X297.0X527.9X758.9X988.8X78.0X307.5X538.1X769.6X998.6X87.0X316.5X547.8X778.6X1008.5X96.3X326.9X557.2X789.4X1019.3X109.4X338.2X568.5X798.2X1028.4X117.4X347.0X579.1X8010.1X1037.8X127.1X356.6X588.9X819.8X1047.8X138.0X367.2X598.2X829.9X1058.6X148.1X377.1X607.7X8310.9//X157.3X387.3X616.5X848.6//X166.6X397.2X627.0X8510.3//

X177.1X408.9X636.7X8611.4//X185.5X419.7X647.7X879.9//X196.4X427.9X658.3X888.6//X207.3X438.4X669.2X899.4//X215.8X447.2X678.5X908.2//X227.1X458.9X688.9X918.2//X235.9X467.3X699.5X928.7//计算平均值为元=7.96；计算移动差距R值如下表:新的子群连续的对子移动差距R新的子群连续的对子移动差距R18.06.31.7547.87.20.626.37.31.0557.28.51.337.37.60.3568.59.10.647.66.61.0579.18.90.256.67.10.5588.98.20.767.18.00.9598.27.70.578.07.01.0607.76.51.287.06.30.7616.57.00.596.39.43.1627.06.70.3109.47.42.0636.77.71.0117.47.10.3647.78.30.6127.18.00.9658.39.20.9138.08.10.1669.28.50.7148.17.30.8678.58.90.4157.36.60.7688.99.50.6166.67.10.5699.58.01.5177.15.51.6708.09.01.0185.56.40.9719.09.00.0196.47.30.9729.09.40.4207.35.81.5739.49.80.4

215.87.11.3749.88.90.9227.15.91.2758.99.60.7235.96.10.2769.68.61.0246.14.41.7778.69.40.8254.44.70.3789.48.21.2264.74.80.1798.210.11.9274.86.61.88010.19.80.3286.67.00.4819.89.90.1297.07.50.5829.910.91.0307.56.51.08310.98.62.3316.56.90.4848.610.31.7326.98.21.38510.311.41.1338.27.01.28611.49.91.5347.06.60.4879.98.61.3356.67.20.6888.69.40.8367.27.10.1899.48.21.2377.17.30.2908.28.20.0387.37.20.1918.28.70.5397.28.91.7928.78.60.1408.99.70.8938.68.70.1419.77.91.8948.77.71.0427.98.40.5957.79.11.4438.47.21.2969.18.20.9447.28.91.7978.28.80.6458.97.31.6988.88.60.2467.36.90.4998.68.50.1476.97.40.51008.59.30.8487.47.20.21019.38.40.9497.29.52.31028.47.80.6509.58.80.71037.87.80.0

518.87.90.91047.88.60.8527.98.10.21058.6//538.17.80.3////计算平均移动极差（即这104个值的平均值）=0.8385移动极差R控制图绘制：CLR=R=0.8385UCLR=D4R=3.27X0.8385=2.74LCLR=D3R=0系数幺3和D4的值按9=2行查表得，由于该移动极差图已呈现出统计控制状态，于是可进行单值控制图的绘图。4单值X控制图绘制： CLx=X=7.96UCLX=X+E2R=X+2.66R=7.96+2.66X0.8385=10.19LCLx=X-E2R=X-2.66R=7.96-2.66X0.8385=5.73采用n=2,查表知E2=2.66。该控制图表明过程处于统计控制状态。・LCLX成品薯薪里昔元含量X控制图粘验必果CLXUCLX0,000002.s8.・LCLX成品薯薪里昔元含量X控制图粘验必果CLXUCLX0,000002.s8.6,4,2.MX§3QTmT50031EisaiEOGOEISTMmT30WC寸cimcjetmlEENT口自T©EFTmo(Iss^goETTTmni0,Q.序号数据序号数据序号数据序号数据序号数据X13.9X234.2X455.2X675.1X894.6X24.0X244.8X465.7X685.2X904.8X34.4X254.3X475.3X695.7X914.6X44.7X264.4X485.4X705.6X924.6X53.8X274.5X495.4X715.0X934.6X64.2X284.2X505.7X725.5X944.4X74.0X294.6X515.7X735.4X954.2X83.9X305.2X525.0X744.7X964.2X93.9X314.4X534.7X754.9X974.6X104.6X324.6X545.0X764.6X984.0X114.3X334.6X554.9X774.6X994.5X124.4X344.6X565.6X785.0X1004.5X135.2X354.5X574.6X794.6X1014.4X144.2X363.8X584.4X804.8X1024.7X153.8X374.2X594.4X814.9X1035.0X164.5X384.2X604.6X824.9X1044.8

X173.9X394.0X614.6X835.0X1054.6X184.2X404.8X624.6X845.0//X194.6X414.7X634.1X854.8//X203.8X425.1X644.9X865.2//X214.7X435.1X655.4X874.7//X224.9X445.2X665.6X884.6//计算平均值为元=4.68；计算移动差距R值如下表:新的子群连续的对子移动差距R新的子群连续的对子移动差距R13.94.00.1545.04.90.124.04.40.4554.95.60.734.44.70.3565.64.61.044.73.80.9574.64.40.253.84.20.4584.44.40.064.24.00.2594.44.60.274.03.90.1604.64.60.083.93.90.0614.64.60.093.94.60.7624.64.10.5104.64.30.3634.14.90.8114.34.40.1644.95.40.5124.45.20.8655.45.60.2135.24.21.0665.65.10.5144.23.80.4675.15.20.1153.84.50.7685.25.70.5164.53.90.6695.75.60.1173.94.20.3705.65.00.6184.24.60.4715.05.50.5194.63.80.8725.55.40.1203.84.70.9735.44.70.7214.74.90.2744.74.90.2

224.94.20.7754.94.60.3234.24.80.6764.64.60.0244.84.30.5774.65.00.4254.34.40.1785.04.60.4264.44.50.1794.64.80.2274.54.40.1804.84.90.1284.44.60.2814.94.90.0294.65.20.6824.95.00.1305.24.40.8835.05.00.0314.44.60.2845.04.80.2324.64.60.0854.85.20.4334.64.60.0865.24.70.5344.64.50.1874.74.60.1354.53.80.7884.64.60.0363.84.20.4894.64.80.2374.24.20.0904.84.60.2384.24.00.2914.64.60.0394.04.80.8924.64.60.0404.84.70.1934.64.40.2414.75.10.4944.44.20.2425.15.10.0954.24.20.0435.15.20.1964.24.60.4445.25.20.0974.64.00.6455.25.70.5984.04.50.5465.75.30.4994.54.50.0475.35.40.11004.54.40.1485.45.40.01014.44.70.3495.45.70.31024.75.00.3505.75.70.01035.04.80.2515.75.00.71044.84.60.2

525.04.70.31054.6//534.75.00.3////计算平均移动极差（即这104个值的平均值）=0.3125移动极差R控制图绘制：CLr=R=0.3125UCLR=D4R=3.27X0.3125=1.02LCLr=D3R=0系数D3和D4的值按9=2行查表得，由于该移动极差图已呈现出统计控制状态，于是可进行单值控制图的绘图14单值X控制图绘制：CLx=X=4.68UCLx=X+E2R=X+2.66R=4.68+2.66X0.3125=5.51LCLx=X-E2R=X-2.66R=4.68-2.66X0.3125=3.85采用n=2,查表知E2=2.66。该控制图表明过程处于统计控制状态。谤制差距谤制差距R——CLRUCLR■LCLR成品甘草酸含量X控制图二验血果,二验血果,CLXUCIX•LCLXDOCITTETClTClTfTDOCITTETClTClTfT5口口KTZTGOElKClGClfT小昌之m«&fLgox601罟NTbdgclETkclRMTIRCIETD口自TLu9口会官rr-.otroEI息三10二IIQcl.小结：本回顾年度生产的 所有批次的性状、鉴别、水分、装量差异、溶散时限、微生物限度、含量的检验结果来看，均符合控标准，合格率达到100%,可以认为在此工艺条件下生产出的产品均能达到产品的质量标准。水分：控标准为不得过7.0%，回顾期限所有数据均符合控标准，平均值约为4.0%，合格率达到100%。从控制图可以看出，各批数据基本在控制上线（UCL）与控制下线（LCL）之间，图型分布也呈正常波动状态，认为此工序对水分的控制处在受控状态下，可以认为在此工艺条件下所生产出的产品水分均能达到产品的质量标准。溶散时限：控标准为W50min,回顾期限所有数据均符合控标准，平均值约为27min,合格率达到100%。从控制图可以看出，各批数据基本在控制上线0CL）与控制下线（LCL）之间，图型分布也呈正常波动状态，认为此工序对溶散时限的控制处在受控状态下，可以认为在此工艺条件下所生产出的产品溶散时限均能达到产品的质量标准。薯蓣皂苷元含量：控标准为本品每1g含粉萆薢以薯蓣皂苷元计，不得少于4.2口8。回顾期限所有数据均符合控标准，平均值约为8.0mg,合格率达到100%。从控制图可以看出，各批数据偶尔在控制上线（UCL）与控制下线（LCL）之外，可能是药材产地不固定导致药材含量不稳定，最终导致成品含量的波动。甘草酸含量：控标准为本品每1g含甘草以甘草酸计，不得少于3.71^。回顾期限所有数据均符合控标准，平均值约为4.7mg,合格率达到100%。从控制图可以看出，各批数据偶尔在控制上线（UCL）与控制下线（LCL）之外，可能是药材产地不固定导致药材含量不稳定，最终导致成品含量的波动。3生产分析3.1关键工艺参数控制情况工序 质量控制点质量控制项目频次总混含量、鉴别、混合时间每批泛丸数量、加水量每批干燥干燥时间、温度、水分随时/每批

包衣时间、粘合剂用量、丸重差异随时包衣丸干燥时间、温度、水分随时/每批选丸外观、丸重差异、鉴别、含量每批包装外观、装量差异、密封性、微生物每批包装小包装说明书、数量、批号随时/每班中包装数量、整齐随时/每批大包装数量、批号、装箱单（合格证）随时/每箱3.2产品各工序平衡率平衡率统计表批号总混物料平衡率(%)泛丸、干燥物料平衡率闾选丸物料平衡率(%)包衣、干燥物料平衡率闾择丸物料平衡率(%)分装物料平衡率闾包装物料平衡率闾成品率(%)小盒(%)1111201100.0099.16100.0098.8999.9699.8699.9695.00100.001111202100.0099.5699.9599.0899.9699.3399.9592.70100.001111203100.0099.32100.0099.0099.9699.6499.9693.66100.001111204100.0099.3899.9599.60100.0099.0399.9694.40100.001111205100.0099.43100.0099.46100.0099.5999.9695.50100.00111120699.9599.89100.0099.2899.9799.2199.9695.26100.001120101100.0099.46100.0099.21100.0098.2699.96103.46100.001120102100.0099.40100.0099.28100.0099.4199.96104.54100.001120201100.0099.38100.0098.7299.9698.8099.9586.04100.001120202100.0099.51100.0098.74100.0098.0899.9584.70100.001120203100.0099.57100.0099.14100.0099.8999.9589.00100.001120204100.0098.94100.0098.8999.9699.0499.9584.20100.001120205100.0098.97100.0099.1099.9699.9699.9586.30100.001120206100.0098.75100.0099.1199.9698.9099.9586.80100.001120207100.0099.3299.9598.5299.9698.2399.9583.90100.001120301100.0099.16100.0099.47100.0098.6999.9588.00100.001

120302100.0099.29100.0099.26100.0098.0299.9587.86100.001120303100.0099.40100.0098.9599.9699.2599.9586.64100.001120304100.0099.02100.0099.0799.9698.5299.9585.94100.001120305100.0099.35100.0099.07100.0099.0699.9587.40100.001120306100.0099.51100.0099.16100.0099.6199.9587.32100.001120307100.0099.35100.0098.92100.0099.3699.9587.30100.001120308100.0099.21100.0098.94100.0099.6399.9587.58100.001120309100.0099.27100.0098.89100.0099.5799.9586.98100.001120310100.0099.21100.0099.05100.0099.2499.9585.38100.001120311100.0099.29100.0098.57100.0099.0199.9586.38100.001120312100.0099.35100.0099.18100.0099.0399.9586.44100.001120601100.0099.3599.9799.74100.0099.1999.9592.00100.001120602100.0099.73100.0099.65100.0095.2499.9586.46100.001120603100.0099.67100.0099.36100.0099.3099.9695.52100.001120604100.0098.80100.0099.74100.0099.6299.96101.00100.001120605100.0099.67100.0099.65100.0099.9199.9695.54100.001120606100.0099.46100.0099.80100.0099.1599.9698.14100.001120607100.0099.62100.0099.61100.0098.1699.9590.58100.001120608100.0099.56100.0099.81100.0099.2599.96100.82100.001120701100.0099.40100.0099.74100.0098.8799.96101.00100.001

120702100.0099.57100.0099.81100.0099.9299.96101.00100.001120703100.0099.35100.0099.65100.0099.5199.96101.00100.001120704100.0099.40100.0099.61100.0099.2999.96101.00100.001120705100.0099.57100.0099.55100.0098.3499.96101.00100.001120706100.0099.40100.0099.65100.0099.9799.96103.40100.001120707100.0099.13100.0099.77100.0099.5399.96101.04100.001120708100.0099.40100.0099.81100.0099.2099.96101.04100.001120709100.0099.31100.0099.73100.0099.8599.9698.64100.001120710100.0099.40100.0099.73100.0099.7599.9698.64100.001120711100.0099.49100.0099.21100.0099.8799.9698.64100.001120712100.0099.37100.0099.37100.0099.7399.9698.64100.001120801100.0098.97100.0099.30100.0099.6399.9698.64100.001120802100.0098.74100.0099.27100.0099.8399.9696.24100.001120803100.0099.20100.0099.27100.0099.5199.9696.24100.001120804100.0098.97100.0099.47100.0099.8499.9696.30100.001120805100.0099.08100.0099.60100.0099.5499.9698.70100.001120806100.0099.20100.0099.90100.0099.7499.9698.70100.001120807100.0099.37100.0099.93100.0099.5899.9698.70100.001120808100.0098.97100.0099.80100.0099.6299.9698.60100.001120809100.0098.80100.0099.40100.0099.2799.9698.60100.001

120810100.0098.80100.0099.73100.0099.7399.9698.60100.0011208n100.0098.80100.0099.90100.0099.9699.96101.00100.001120812100.0098.97100.0099.25100.0099.9599.9591.40100.001120813100.0098.86100.0099.28100.0099.8799.9693.80100.001120814100.0098.97100.0099.49100.0099.7999.9591.40100.001120815100.0099.31100.0099.60100.0099.9399.9696.20100.001120816100.0099.09100.0099.27100.0099.8699.9698.60100.001120817100.0098.81100.0099.32100.0098.7399.9693.80100.001120818100.0098.86100.0099.26100.0099.5099.9693.80100.001120819100.0098.76100.0099.26100.0099.5199.9693.80100.001120820100.0098.75100.0099.05100.0099.6899.9591.40100.001120821100.0098.81100.0099.19100.0099.7099.9693.80100.001120822100.0098.70100.0099.32100.0099.8599.9693.80100.001120901100.0098.81100.0099.25100.0099.7299.9693.80100.001120902100.0098.64100.0099.25100.0099.6599.9693.80100.001120903100.0098.87100.0099.32100.0099.8799.9693.80100.001120904100.0098.76100.0099.39100.0099.4199.9693.80100.001120905100.0099.03100.0099.83100.0099.6799.9693.80100.001120906100.0099.25100.0099.59100.0099.9099.7596.00100.001120907100.0098.85100.0099.33100.0099.9499.8996.20100.001

120908100.0098.80100.0099.46100.0099.9499.9696.20100.001120909100.0099.03100.0099.80100.0099.7599.9696.20100.001120910100.0099.37100.0099.63100.0099.3399.9693.80100.001120911100.0099.09100.0099.59100.0099.0399.9693.80100.001120912100.0098.80100.0099.32100.0099.3499.9693.80100.001121001100.0099.09100.0099.32100.0098.9399.9693.80100.001121002100.0098.80100.0099.39100.0098.3299.9591.40100.001121003100.0099.38100.0099.36100.0099.6699.9696.20100.001121004100.0099.06100.0099.41100.0099.7299.9693.80100.001121005100.0099.12100.0099.42100.0099.3999.9696.20100.001121006100.0098.91100.0099.42100.0099.3399.9698.60100.001121007100.0099.12100.0099.62100.0099.2699.9698.60100.001121008100.0099.33100.0099.71100.0099.4199.96101.00100.001121009100.0099.43100.0099.55100.0099.5699.97101.00100.001121010100.0099.17100.0099.52100.0097.3899.9698.60100.001121011100.0099.38100.0099.65100.0099.9999.96101.00100.001121012100.0099.32100.0099.65100.0099.8599.96101.00100.001121101100.0098.96100.0099.47100.0099.2899.96103.40100.001121102100.0099.22100.0099.44100.0099.8699.96105.80100.001121103100.0099.12100.0099.47100.0099.7799.96103.40100.001

12n04100.0099.06100.0099.53100.0099.9899.96105.80100.00112n05100.0099.12100.0099.56100.0095.3699.96101.00100.001121106100.0099.06100.0099.53100.0099.4699.96108.20100.001121107100.0099.06100.0099.53100.0099.8199.96105.80100.001121108100.0099.17100.0099.47100.0099.7999.96108.20100.001121109100.0099.43100.0099.47100.0099.6899.96105.80100.001121110100.0099.01100.0099.44100.0098.2699.96105.80100.001121111100.0099.06100.0099.50100.0099.6599.96108.20100.001121112100.0099.06100.0099.56100.0099.7499.96108.20100.001最大值100.0099.89100.0099.93100.0099.9999.97108.20100.001最小值99.9598.6499.9598.5299.9695.2499.7583.90100.001平均值100.0099.18100.0099.40100.0099.3399.9595.92100.001评价：回顾期限所有放行批次各工序物料平衡率都在合格围。4质量事故回顾:无。5偏差回顾:无。6超常超标回顾OOS编号批号描述涉与批次方案结果PC-OOS-2012003121204、121205、121206 总混粉的甘草酸含量检验结果出现异常，不符合控标准。3进行实验室偏差调查，并安排原样自复。原样复检结果合格，判定为实验室偏差。评价：本回顾期限共发生一起005,已关闭。7长期稳定性试验批号：120201项目（标准规定）放置时间试验日期0月3月2012.56月2012.89月2012.11性状应符合规定符合规定符合规定符合规定符合规定鉴别应符合规定符合规定符合规定符合规定符合规定水分不得过9.0%3.5%4.1%3.6%4.4%装量差异应符合规定符合规定符合规定符合规定符合规定溶散时限60min32min27min25min27min含量（甘草酸）3.0mg/g3.9mg/g4.1mg/g3.8mg/g4.3mg/g含量（薯蓣皂苷元）4.0mg/g6.4mg/g7.9mg/g6.5mg/g7.9mg/g细菌数（cfu/g）不得过30000325<1010150霉菌和酵母菌数（cfu/g）不得过10030<10<10<10大肠菌群（个/g）应〈100<10<10<10<10大肠埃希菌不得检出未检出未检出未检出未检出批号：120202放置时间试验日期项目（标准规定） 一~^^一0月3月2012.56月2012.89月2012.11性状 应符合规定符合规定符合规定符合规定符合规定

鉴别应符合规定符合规定符合规定符合规定符合规定水分不得过9.0%4.5%4.5%4.3%4.7%装量差异应符合规定符合规定符合规定符合规定符合规定溶散时限60min26min27min26min27min含量（甘草酸）3.0mg/g4.6mg/g4.5mg/g4.3mg/g4.4mg/g含量（薯蓣皂苷元）4.0mg/g9.4mg/g7.8mg/g9.3mg/g7.5mg/g细菌数（cfu/g）不得过300002505535325霉菌和酵母菌数（cfu/g）不得过100<1015<10<10大肠菌群（个/g）应〈100<10<10<10<10大肠埃希菌不得检出未检出未检出未检出未检出批号：120203项目（标准规定）放置时间试验日期0月3月2012.56月2012.89月2012.11性状应符合规定符合规定符合规定符合规定符合规定鉴别应符合规定符合规定符合规定符合规定符合规定水分不得过9.0%5.0%4.5%4.3%4.6%装量差异应符合规定符合规定符合规定符合规定符合规定溶散时限60min34min28min26min26min含量（甘草酸）3.0mg/g4.3mg/g4.1mg/g4.1mg/g4.2mg/g含量（薯蓣皂苷元）4.0mg/g7.4mg/g7.7m