THE 2-MINUTE RULE FOR VALIDATION PROTOCOL DEVIATION

The 2-Minute Rule for validation protocol deviation

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Wherever the manufacturer of a nonsterile API both intends or promises that it's appropriate for use in further processing to provide a sterile drug (medicinal) solution, water Utilized in the final isolation and purification actions should be monitored and controlled for overall microbial counts, objectionable organisms, and endotoxins.Regulatory

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