Aseptic processing contamination case studies and the pharmaceutical quality system.
نویسنده
چکیده
This paper summarizes parenteral drug contamination case studies presented at industry conferences and a Food and Drug Administration advisory committee meeting in the period of 2000-2004. CGMP deficiencies associated with each contamination event are discussed. The key role of a well-functioning quality system in contamination prevention is emphasized.
منابع مشابه
Restricted Access Barrier Systems (RABS) & Isolators: The Perfect Combination of Robot System Safety and Aseptic Drug Manufacturing
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BACKGROUND Administration of parenteral doses with microbial contamination can lead to infective morbidity or death. AIM To test whether aseptic preparation of parenteral doses or additives to sterile doses undertaken in dedicated pharmaceutical rather than clinical environments reduces the risk of microbial dose contamination. METHODS Data identified from a systematic review were examined ...
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Pharmaceutical products are classified into two groups according to the microbiological point of view: 1) sterile products and 2) non-sterile products. The sterilized term refers to the products that are free of any microorganisms, their production were done under aseptic conditions, but the production of non-sterile products were not under aseptic conditions; therefore, they are not free from ...
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1 3 0 • H O S P I TA L P H A R M AC I S T Aseptic preparation of medicines in hospital pharmacy units usually comprises the combination of licensed sterile ingredients in a manner that will ensure that the resulting product, in its final container, is sterile. One of the inherent weaknesses of this activity is that aseptically prepared medicinal products cannot be tested for sterility as would ...
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ورودعنوان ژورنال:
- PDA journal of pharmaceutical science and technology
دوره 59 2 شماره
صفحات -
تاریخ انتشار 2005