阿莫西林膠囊產(chǎn)品回顧性驗證

PAGEPAGE1阿莫西林膠囊產(chǎn)品回顧性驗證驗證方法：1需收集的工藝項目及支持數(shù)據(jù)：項目控制范圍裝量：±10%含量：90.0—10%水分：≤16.0%溶出度：45分鐘不低于80%驗證項目抽取說明：裝量：根據(jù)裝量曲線可以判定產(chǎn)品工藝、設備的適應性穩(wěn)定性方面是否適合現(xiàn)有產(chǎn)品的特點。含量：根據(jù)含量曲線可以判定該產(chǎn)品用該工藝生產(chǎn)的質(zhì)量的整體水平。溶出度和水分：根據(jù)溶出度和水分曲線可以判定該產(chǎn)品用該工藝生產(chǎn)能夠生產(chǎn)出質(zhì)量性狀穩(wěn)定的產(chǎn)品。1.2年度質(zhì)量回顧報告2樣本的抽?。?004年阿莫西林膠囊(250mg/粒)生產(chǎn)工藝穩(wěn)定，產(chǎn)品質(zhì)量合格，工藝未出現(xiàn)任何波動。故收集25批連續(xù)性生產(chǎn)的膠囊裝量、含量、水分、溶出度的數(shù)據(jù)，根據(jù)這些數(shù)據(jù)對控制狀態(tài)進行分析，比較差異性。計算“移動極差”求出控制上限（UCL）及控制下限（LCL），根據(jù)工藝項目及參數(shù)的范圍，通過作圖比較每一個原始檢驗結(jié)果是否均在控制限度范圍的中心或是接近中心，由此可確定阿莫西林膠囊的生產(chǎn)方法是符合質(zhì)量要求的，行之有效的生產(chǎn)工藝。3制作以批號的序號為橫坐標，成品裝量、含量、水分、溶出度的數(shù)據(jù)各為縱坐標的控制圖和以批號的序號為橫坐標，成品裝量、含量、水分、溶出度的數(shù)據(jù)的“移動極差”為縱坐標的控制圖，考察其與控制限度范圍的關(guān)系。計算方法：4.1計算平均值：X=（∑Xi）/n；4.2計算移動差距，MR（絕對值）X2-X1、X3-X2、……Xn-Xn-1；4.3計算平均移動極差MR，即n個MR的平均值；4.4計算控制限度：ULC=X+E2MRLCL=X-E2MR5控制圖：5.1裝量圖：收集的數(shù)據(jù)：產(chǎn)品批號裝量X（mg）新產(chǎn)生的序號Xn+1Xn|Xn+1－Xn|（MR）1.040104293129429312.040105294229429403.040207294329629424.040208296429729615.040209297529529726.040314295629529507.040315295729229538.040320292829329219.0404102939296293304041129610297296111.04041229711293297412.04041329312298293513.04042129813293298514.04050329314294293115.04050429415293294116.04050729316296293317.04050829617295296118.04080429518295295019.04090329519296295120.04100629620298296221.04100829821297298122.04101229722294297323.04101329423292294224.04101429224293292125.041104293合計=SUM(ABOVE)44合計=SUM(ABOVE)7369平均1.8平均295N=2，查表知E2=2.66、D3=0、D4=3.27X圖（mg）：CLX=295UCLX=295＋1.8×2.66=300LCLX=295－1.8×2.66=290根據(jù)以上數(shù)據(jù)作X圖：MR圖：CLR=1.8UCLR=3.27×1.8=5.89LCLR=0根據(jù)以上數(shù)據(jù)作MR圖：5.2含量圖：收集的數(shù)據(jù)：產(chǎn)品批號含量X（%）新產(chǎn)生的序號Xn+1Xn|Xn+1－Xn|（MR）1.04010499.8199.899.802.04010599.8299.299.80.63.04020799.2399.299.204.04020899.24100.199.20.95.040209100.15100.0100.10.16.040314100.0699.7100.00.37.04031599.7799.399.70.48.04032099.3898.799.30.69.04041098.79100.598.71.8040411100.510100.4100.50.111.040412100.41198.8100.41.612.04041398.81299.398.80.513.04042199.31398.699.30.714.04050398.61498.198.60.515.04050498.11599.498.11.316.04050799.41699.699.40.217.04050899.61797.299.62.418.04080497.21897.397.20.119.04090397.31999.697.32.320.04100699.620100.199.60.521.041008100.121101.5100.11.422.041012101.522100.4101.51.123.041013100.42399.7100.40.724.04101499.72499.199.70.625.04110499.1合計=SUM(ABOVE)18.7合計=SUM(ABOVE)2485.4平均0.78平均99.42N=2，查表知E2=2.66、D3=0、D4=3.27X圖（%）：CLX=99.42UCLX=99.42＋0.78×2.66=101.49LCLX=99.42－0.78×2.66=97.34根據(jù)以上數(shù)據(jù)作X圖：MR圖：CLR=0.78UCLR=3.27×0.78=2.55LCLR=0根據(jù)以上數(shù)據(jù)作MR圖：溶出度圖：收集的數(shù)據(jù)產(chǎn)品批號溶出度X（%）新產(chǎn)生的序號Xn+1Xn|Xn+1－Xn|（MR）1.04010410019610042.0401059621029663.04020710239810244.0402089841009825.040209100510010006.04031410069710037.040315977999728.040320998959949.0404109599695104041196109696011.04041296119696012.04041396129396313.04042193139793414.04050397149997215.040504991510099116.0405071001697100317.040508971710097318.0408041001895100519.04090395199395220.04100693209593221.04100895219295322.04101292229092223.04101390239390324.04101493249693325.04110496合計=SUM(ABOVE)62合計=SUM(ABOVE)2415平均2.58平均96.6N=2，查表知E2=2.66、D3=0、D4=3.27X圖（%）：CLX=96.6UCLX=96.6＋2.58×2.66=103.46LCLX=96.6－2.58×2.66=89.74根據(jù)以上數(shù)據(jù)作X圖：MR圖：CLR=2.58UCLR=3.27×2.58=8.44LCLR=0根據(jù)以上數(shù)據(jù)作MR圖：水分圖：收集的數(shù)據(jù)產(chǎn)品批號水分X（%）新產(chǎn)生的序號Xn+1Xn|Xn+1－Xn|（MR）1.04010412.6112.412.60.22.04010512.4212.212.40.23.04020712.2312.412.20.24.04020812.4412.212.40.25.04020912.2512.212.206.04031412.2612.312.20.17.04031512.3712.412.30.18.04032012.4812.612.40.29.04041012.6912.312.60.304041112.31012.712.30.411.04041212.71112.412.70.312.04041312.41212.712.40.313.04042112.71312.412.70.314.04050312.41412.512.40.115.04050412.51512.312.50.216.04050712.31612.512.30.217.04050812.51712.212.50.318.04080412.21812.712.20.519.04090312.71912.612.70.120.04100612.62012.312.60.321.04100812.32112.712.30.422.04101212.72212.812.70.123.04101312.82312.812.8024.04101412.82412.612.80.225.04110412.6合計=SUM(ABO