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Research Article for understanding systematic approach to achieve quality standards by Quality Risk Management as per ICH Q9
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Dr. Shiba Morris, Ms. Arati Tamta and Mr. Munish Sharma


To lay down a Standard Operating Procedure to provide systematic approach to achieve quality standards by assessing, controlling, communicating and reviewing risks related to products, equipment’s, utilities, facility, QMS (i.e.Change control, deviation, OOS, OOT, Market complaint, Self-inspection QA analytical review etc.), GMP computer systems  and environment.


Key Words:Risk Priority Number, Key Quality Risk Management, Risk Assessment, Risk Acceptance, Risk Control.

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