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Methods of monitoring acceptance criteria of pharmaceutical manufacturing processes

  • US 20090143892A1
  • Filed: 01/29/2009
  • Published: 06/04/2009
  • Est. Priority Date: 05/06/2004
  • Status: Active Grant
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1. ) A method of monitoring an acceptance criteria of a pharmaceutical manufacturing process and taking corrective action said method comprising,a) monitoring data generated by a pharmaceutical manufacturing process during pharmaceutical manufacture;

  • b) maintaining the data over time to provide a historical record;

    c) analyzing the historical record to provide a comparative analysis against an acceptance criteria;

    d) taking corrective action to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture.

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