If drinking (potable) water is inadequate to be certain API quality and tighter chemical and/or microbiological h2o top quality specs are called for, ideal specs for physical/chemical characteristics, whole microbial counts, objectionable organisms, and/or endotoxins ought to be proven.Any out-of-specification result received ought to be investigat
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the premises, supporting utilities, and machines run in accordance with their structure requirements (operational qualification or OQ); and a selected procedure will continuously produce a product meeting its predetermined specs and excellent characteristics (process validation or PV, also known as effectiveness qualification or PQ)Guidance and met
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