證書申請遞交的質(zhì)量綜述模板qos-資料下載頁
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【正文】 quested (. in a clear and understandable manner).簡要描述用于原料藥貯存和運(yùn)輸?shù)娜萜髅荛]系統(tǒng)，在CEP中應(yīng)被提及以防復(fù)測期需要（即，用一種清楚明白的方式）(b) Summarise the specifications (description + identification)概述規(guī)格（種類+鑒定） Stability 穩(wěn)定性研究State retest period claimed for the substanceand storage remendations if any:如果有的話，列出對于原料藥及貯存建議的復(fù)測期聲明 Stability Summary and Conclusions 穩(wěn)定性研究總結(jié)和結(jié)論 (a) Summarise accelerated and long term testing (., studies conducted, protocols used, results obtained).概述加速和長期試驗(yàn)（如：研究方式，使用草案，研究結(jié)果）(b) Justify of the retest period claimed based on data available.證明聲明的復(fù)測期基于有效的數(shù)據(jù) Postapproval Stability Protocol and Stability Commitment批準(zhǔn)后穩(wěn)定性研究方案和穩(wěn)定性研究承諾 Give the stability protocol for mitment batches提供承諾批次的穩(wěn)定性方案 COMPLEMENTARY INFORMATION TO BE PROVIDED提供的補(bǔ)充資料I Tests needed in addition / replacement of the tests of the monograph附加或代替藥典方法的試驗(yàn)Give a summary of the additional specifications提供附加標(biāo)準(zhǔn)的說明Give separate annexes for each individual method (not included in the monograph) in a suitable format to be appended to the certificate of suitability (. instrumental parameter, calculation, illustrative chromatogram…) 用恰當(dāng)?shù)母袷綄⒚總€獨(dú)立方法（非藥典收載）分別作為附件附加于適用性證書里（如：儀器參數(shù)，計算方法，說明性色譜圖……）II Omission of tests省略的實(shí)驗(yàn)State the name of test described in the Ph Eur monograph that can be omitted for the control of the substance. Justify shortly.列出在原料藥的控制中可以省略的EP試驗(yàn)方法名稱。簡單證明。III Retest period (if requested)復(fù)測期State the retest period that is proposed for the substance and describe briefly in a clear and understandable manner the mercial container used for storage as well as the remended storage conditions if any.列出對原料藥建議的復(fù)測期，清晰明了的簡單描述用于貯存的商業(yè)貨柜及建議的貯存條件（如果有的話）IV Miscellaneous:雜項(xiàng)Provide copy of the curriculum vitae of the expert.提供專家履歷的復(fù)印件9 / 9
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