importance in the pharmaceutical industry. The current good manufacturing practices (CGMP) regulations recognize that cleaning is a critical issue to ensure product quality. Virtually every aspect of manufacturing involves cleaning, from the initial stages of bulk production to the final dosage form....
1.3Scope适用范围Thispaperappliestobiopharmaceutical,bulkpharmaceuticalandfinisheddosageformoperations;liquid,dry,solidandsemi-soliddosageformsarecoveredinbothsterileandnon-sterilepresentations.Bothclinicalandmarketedproductcleaningvalidationprogramsareidentified.本文件适用于生物制药、原料药及最终剂型:液体、干品、固体及半...
Investigational Medicinal Product:A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. 临床用药品:活性物质或安慰剂的药物制剂,用于临床试验的测试或对照。 LD50:The dose of a material which results in 50% mortality in an animal test 半数...
Virtually every aspect of manufacturing involves cleaning, from the initialstages of bulk productiontothefinaldosageform. 近年来,清洗步骤在制药行业逐渐发挥着重 CGMP 要作用。现行良好生产规范 ( )认为清洗是确保产品质量的关键步骤。事实上,生产的每方面,从 原料药生产的最初阶段到最终剂型都涉及清洗。 The ...
Investigational Medicinal Product :A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. 临床用药品:活性物质或安慰剂的药物制剂,用于临床试验的测试或对照。 LD50 :The dose of a material which results in 50% mortality in an animal test ...
3.16 Dot matrix: Array of points of ink, light or simi- lar image-forming elements that are used to form al- phanumeric characters. 3.17 Dots per inch (dpi): Measure 24、of output device resolution and quality, e.g., number of pixels per inch on display device. Measures the number ...
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Terminal Form GULL WING GULL WING Terminal Pitch 0.5 mm 0.5 mm Terminal Position DUAL DUAL Toggle Bit YES YES Type NOR TYPE NOR TYPE Width 12 mm 12 mm Base Number Matches 1 1 Part Package Code TSOP Pin Count 48 Memory » Flash Memories Memory » Flash Memories 比较...
Mẹo: If you cannot configure your form template to allow users to submit their forms to an external data source by using the InfoPath data connection options, you can use this feature to write your own implementation of a data connection to that external data...
PDA TR29(1998)中英文对照版[1]