Home Analytic Chemistry • Download PDF by David M. Bliesner: Establishing A CGMP Laboratory Audit System: A Practical

Download PDF by David M. Bliesner: Establishing A CGMP Laboratory Audit System: A Practical

By David M. Bliesner

ISBN-10: 0471738409

ISBN-13: 9780471738404

the 1st systematic, hands-on auditing consultant for latest pharmaceutical laboratories

In latest litigious setting, pharmaceutical laboratories are topic to ever stricter operational instructions as mandated by way of the FDA, and needs to be capable of determine and show sustainable operational practices that verify compliance with the present strong production perform (CGMP) rules. David Bliesner's setting up a CGMP Laboratory Audit method: a pragmatic consultant is designed to supply laboratory supervisors and body of workers with a step by step, hands-on audit process that they could depend upon to make sure their facility is still compliant with all present and destiny specifications. targeting a "team approach," the writer makes use of specified flowcharts, checklists, and outlines of the auditing strategy to aid readers improve a brand new audit process or improve their present procedure so as to:
* enhance present compliance
* exhibit sustainable compliance
* Produce information for federal inspections
* stay away from regulatory action

more suitable with exact checklists and a wealth of useful and versatile auditing instruments on CD-ROM, this e-book offers a fantastic source for brand spanking new and destiny laboratory group of workers, and a very good capacity for protecting present practitioners brand new at the nuances of working a continually compliant pharmaceutical laboratory.

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Establishing A CGMP Laboratory Audit System: A Practical Guide by David M. Bliesner


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