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No. 21 CFR 211.113(a) requires appropriate published methods to be set up and adopted through manufacturing to prevent objectionable microorganisms in drug solutions not needed to be sterile. Additionally, the 2nd paragraph of USP Typical Chapter Antimicrobial Success Tests reads: Antimicrobial preservatives really should not be made use o
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Report and investigate deviations such as temperature excursions or product hurt through transportation.Mặc dù còn nhiều hạn chế nhưng việc tìm một chỉ số khác thay thế GDP cũng rất khó khăn. Một sự thay thế được biết đến là Chỉ số tiến bộ thực sự (GPI) được cổ động bởi Đảng Xanh
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Products, components, and supplies are launched into the isolator by way of a range of various techniques: usage of a double-door autoclave; constant introduction of elements by using a conveyor belt passing through a sterilizing tunnel; usage of a transfer container system by way of a docking method in the isolator enclosure. It is also important