Six sigma in pharma industry

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    Dear all,
    anybody give me guidance for – ” How to implement six sigma in API industries “



    Same as you’d start in any other area.  Figure out what the processes are.  Are your processes in control?  If not, eliminate the special causes and focus on where the common cause variability is coming from.  Improve your raw material, process time, and parameter consistencies.  Don’t try making significant process changes until you’ve got control.
    Look at reducing your batch size and increasing the frequency of your lots.  This is critical to get the repetitions needed for process monitoring and improvement.  It may also help reduce your WIP, raw material inventories, and finished material inventories.  Your biggest problem in reducing batch sizes will likely be in your existing tank farm.  Regulatory and testing issues will also have an impact.
    If you’ve got continuous processes in place, evaluate your raw material sources, process controls, process flows, and analytical methods.  Attempt to eliminate variability with in-coming materials beyond simply “meeting specifications”.  To alleviate the strain on your QC, QA, and production groups, investigate PAT methods for process monitoring, electronic batch records, and further continuous process improvements.

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