新版gmp解析及應(yīng)對國際檢查(胡廷熹)-資料下載頁
2025-01-02 08:33本頁面
【正文】 ng of out of specification laboratory results實(shí)驗(yàn)室結(jié)果不合規(guī)定的處理 28 Stability study and retest/ expiry dating of finished goods穩(wěn)定性研究和制成品的再試期和失效期 29 Sampling procedure for raw material, packing materials and finished goods原輔料、包裝材料和成品的取樣規(guī)程 30 Laboratory equipment calibration and preventive maintenance實(shí)驗(yàn)室設(shè)備的矯正和預(yù)防維護(hù) 31 Analytical method validation分析方法的驗(yàn)證 32 Validation and handing of puterized system計(jì)算機(jī)系統(tǒng)的驗(yàn)證和處理 33 Handling of laboratory raw data檢驗(yàn)室原始數(shù)據(jù)的處理 34 Handling of reagents and standard試劑和標(biāo)準(zhǔn)的處理 35 Handling of sample for testing受試樣品的處理 36 Raw material specification 原輔料的規(guī)格 Facility、 equipment and production設(shè)施設(shè)備和生產(chǎn) 37 Identification of room/ equipment潔凈房間和設(shè)備的確認(rèn) 37 Qualification procedure確認(rèn)程序 39 Execution of Qualification protocols確認(rèn)方案的執(zhí)行 40 Requalification of Equipment and handling of requalification failures設(shè)備的再確認(rèn)和再確認(rèn)失敗的處理 41 Equipment Preventative and breakdown maintenance設(shè)備的預(yù)防和維修 42 Facility cleaning and sanitization practice 設(shè)施的清洗和消毒實(shí)踐 43 Usage of equipment and equipment cleaning/ sanitization practice設(shè)備的使用、清洗和消毒實(shí)踐 44 Batch numbering批號編寫 45 Line Clearance清場 46 Inprocess check中間過程核查 47 Stability study and retest/ expiry dating of finished goods 穩(wěn)定性研究和制成品的再試期和失效期 48 Production environment control 生產(chǎn)環(huán)境控制 49 Test of water system 水系統(tǒng)檢測 50 Test of HVAC system 空調(diào)系統(tǒng)檢測 Material control物料控制 51 Warehousing management procedure倉儲管理程序 52 Retesting of packaging and raw materials包裝材料和原輔料的再檢測 53 Dispatch and distribution物料的出庫和分發(fā) 54 Raw material specification 原輔料的規(guī)格 55 Packaging material development包裝材料的開發(fā) 56 Printed packaging material control已打印包裝材料的控制 57 Packaging operation包裝操作規(guī)程 謝謝觀看 /歡迎下載 BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES. BY FAITH I BY FAITH
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