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Where the producer of the nonsterile API both intends or statements that it's well suited for use in even further processing to provide a sterile drug (medicinal) product, water used in the ultimate isolation and purification ways needs to be monitored and controlled for overall microbial counts, objectionable organisms, and endotoxins.Pharma firms
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In setting up true root cause in an investigation, some traps contain conclusions which include, "Machines failure - it just broke" or "Human mistake - the treatment is inaccurate or the employee created a oversight, The client did not make use of the unit as intended..." To drill right down to the real root cause in instances the place user error
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