Subject: upstream processing area pharm. Manufacturing and operations activities are performed in specifically defined areas,including: a) the GMP warehouse, where receipt, identification, storage and quarantine of raw materials, product container-closure systems and labels is done pending sampling and testing for release to manufacturing. The warehouse contains separate areas for holding rejected materials and products before disposition, and for storage of released materials and products; b) the upstream processing area, which contains separate areas for the bioreactor suite, the fermentation suite, processing hall, in-process control laboratory and storage areas for in-process materials; |
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link 22.10.2009 11:05 |
вариант предыдущий или предшествующий технологический участок |
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