کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5516989 1400864 2016 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Short paperStudy of twenty preparations of human albumin solution which failed in quality control testing due to elevated sodium content, a poor internal quality control at manufacturing unit
ترجمه فارسی عنوان
مقاله کوتاه مطالعات بیست وپنج از راه حل آلبومین انسانی که در آزمایش کنترل کیفیت با توجه به افزایش محتوای سدیم، کنترل ضعیف داخلی در واحد تولید
کلمات کلیدی
راه حل آلبومین انسانی، سدیم، کنترل کیفیت، تجزیه و تحلیل روند،
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیوشیمی، ژنتیک و زیست شناسی مولکولی (عمومی)
چکیده انگلیسی

Current study is conducted in our laboratory due to failure in quality control testing of twenty batches of Human Albumin solution in which sodium content is higher than the prescribed limit. These batches are received in short duration from indigenous manufacturer and is the first incident of failure of Human albumin preparation in sodium content of manufacturer. On request of manufacturer, study is conducted to rule out the cause. Repeat testing of each out of specification batch is conducted and a trend analysis is drawn between our findings and manufacturer's results, also study of trend analysis of manufacturer for the last one year. Trend analysis data indicated towards poor consistency of batches with major shift at various time intervals in sodium content of human albumin preparation. Further analysis rule out that non-traceable quality of standard used in the internal quality control testing by manufacturer is the root cause of the problem.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Biologicals - Volume 44, Issue 6, November 2016, Pages 591-595
نویسندگان
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