【正文】 照新版GMP進(jìn)行再次培訓(xùn)，無論從操作技術(shù)還是生產(chǎn)理念都有很大的提高。長治市三寶生化藥業(yè)有限公司 利巴韋林注射液生產(chǎn)工藝驗(yàn)證方案長治市三寶生化藥業(yè)有限公司方案制訂 簽名 日期 方案會簽 簽名 日期 生產(chǎn)技術(shù)部簽名 日期 驗(yàn)證小組簽名 日期 方案批準(zhǔn) 質(zhì)量保證部 日期 目 錄`````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````4` ``````````````````````````````````````````````````````````````````````````````````````````````````````````````4``````````````````````````````````````````````````````````````````````````````````````````````````````````4``````````````````````````````````````````````````````````````````````````````````````````````````````````5`````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5```````````````````````````````````````````````````````````````````````````````````````````````````````````````6```````````````````````````````````````````````````````````````````````````````6````````````````````````````````````````````````````````````````````````````````````````````````````````````````````7``````````````````````````````````````````````````````````````````````````````````````````````````````8` ````````````````````````````````````````````````````````````````````````````````````````````````````````````8 ```````````````````````````````````````````````````````````````````````````````````````````````````````````12 ```````````````````````````````````````````````````````````````````````````````````````````````````````````15 ```````````````````````````````````````````````````````````````````````````````````````````````````````````20 ```````````````````````````````````````````````````````````````````````````````````````````````````````````24 ```````````````````````````````````````````````````````````````````````````````````````````````````````````26 ``````````````````````````````````````````````````````````````````````````````````````````````````28``````````````````````````````````````````````````````````````````````````````````````````````````````````````````29``````````````````````````````````````````````````````````````````````````````````````````````````````````````````29````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````29 . 設(shè)備一覽表及生產(chǎn)能力```````````````````````````````````````````````````````````````````````````````30 ```````````````````````````````````````````````````````````````31 ````````````````````````````````````````````````````````````````````32 `````````````````````````````````````````````34 、工藝用水系統(tǒng)驗(yàn)證的確認(rèn)和檢查情況表`````````````````35 ```````````````````````````````````````````````````````````````````````````````````````36 （按四批準(zhǔn)備）驗(yàn)證使用的原料、輔料和安瓿 供應(yīng)商確認(rèn)及檢查情況表`````````````````````````````````````````````````````````````````````````````37 ```````````````````````````````````````````````````````````````38 ``````````````````````````````````````````````````````````````````````````````````````39 ````````````````````````````````````````````````````````````````````````````````````40 、監(jiān)控內(nèi)容、監(jiān)控方法、監(jiān)控頻次表`````````````````````````````41（1ml：100mg）常溫狀態(tài)下是無色的澄明液體，屬抗病毒藥，用于呼吸道合胞病毒引起的病毒性肺炎與支氣管炎。，具體工藝處方如下：處方： 物料名稱 1ml：100 mg利巴韋林 1000g氯化鈉 87g藥用炭 20g共制成 10000支處方依據(jù)： 中國藥典2010年版二部 批準(zhǔn)文號：國藥準(zhǔn)字H19999232 批準(zhǔn)機(jī)構(gòu)：國家藥品監(jiān)督管理局： 利巴韋林氯化鈉安瓿注射用水濃配粗濾洗配精濾灌封燈檢包裝入庫粗洗過濾過濾精洗干燥滅菌冷卻滅菌檢漏活性炭外包裝材料A級潔凈區(qū)B級潔凈區(qū)該產(chǎn)品從2010年批準(zhǔn)生產(chǎn)以來，處方和生產(chǎn)工藝沒有發(fā)生變更，產(chǎn)品質(zhì)量基本穩(wěn)定，沒有質(zhì)量事故發(fā)生。2. 驗(yàn)證目的根據(jù)2010版GMP要求，通過對利巴韋林注射液(1ml：100mg)產(chǎn)品工藝的驗(yàn)證，判斷生產(chǎn)系統(tǒng)各要素和生產(chǎn)過程中可能影響產(chǎn)品質(zhì)量的各種工藝變化因素，對其整個(gè)生產(chǎn)過程進(jìn)行驗(yàn)證，以保證在正常的生產(chǎn)條件下，生產(chǎn)出合格、均一、穩(wěn)定的利巴韋林注射液。3. 驗(yàn)證的范圍本次驗(yàn)證是在該產(chǎn)品正常生產(chǎn)所需的廠房設(shè)施、生產(chǎn)設(shè)備、儀器儀表、檢驗(yàn)設(shè)施設(shè)備及檢驗(yàn)方法均經(jīng)過了驗(yàn)證和校驗(yàn)、參與驗(yàn)證的相關(guān)人員都經(jīng)過培訓(xùn)的前提下，按照批準(zhǔn)的生產(chǎn)工藝規(guī)程和崗位SOP進(jìn)行嚴(yán)格監(jiān)控下的正常生產(chǎn)；所有記錄真實(shí)、準(zhǔn)確；所有抽樣檢驗(yàn)嚴(yán)格按照批準(zhǔn)的規(guī)程進(jìn)行。4. 驗(yàn)證各部門職責(zé)及組織機(jī)構(gòu) 。 。 。 、設(shè)備的驗(yàn)證。 。 。 、試驗(yàn)記錄，并對試驗(yàn)結(jié)果進(jìn)行分析后，起草驗(yàn)證告，報(bào)驗(yàn)證委員會。 。 ，若因特殊原因確需變更時(shí)，應(yīng) 填寫驗(yàn)證方案變更申請書，報(bào)驗(yàn)證組批準(zhǔn)。參加驗(yàn)證人員必須經(jīng)過培訓(xùn)，培訓(xùn)結(jié)果及有關(guān)文件見附表3。 . 因素分析本工序主要控制參數(shù)有：； ； ；；e. 遠(yuǎn)紅外隧道烘箱的滅菌溫度和滅菌時(shí)間。在************GMP管理工作中，進(jìn)行了如下修訂。檢查頻次：每隔2小時(shí)檢測1次************* 時(shí) 分 時(shí) 分 時(shí)