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“If I saw a competitor’s drug being used in a single of my accounts, the first thing I'd do is evaluate the situation. I might check with the physician or healthcare supplier to understand why they selected the competitor’s product and what Gains it provides that our solution isn't going to.After I have collected this info, I'd personally the
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The operating conditions for the BFS method and the character of plastic ampuls pose numerous difficulties to The soundness and integrity of biological drug merchandise. In this post, the authors go over things to consider in the event and manufacturing of biological products and solutions utilizing the BFS process, together with possible solution
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Whilst there isn't any complete microbial criteria for water (apart from water intended to be sterile), the CGMP rules need that suitable technical specs be recognized and monitored. The specification have to consider the meant use from the water; i.It is acknowledged, nonetheless, that other mixtures of media and incubation time and temperature ma