1Department of Quality Assurance, Kisan Vidya Prasarak Sanstha’s, Institute of Pharmaceutical Education, Boradi, 425428
2Research Scholar, Sankalchand Patel University, Visnagar – 384315, Gujarat, India
Every product in the pharmaceutical sector has some level of risk. The new guidelines define risk as the sum of the potential the damage will occur and the seriousness of that damage. In order to maximize benefits and balance risk, quality risk management, or QRM, is the comprehensive and ongoing process of reducing risks to product quality throughout its lifecycle. It’s the methodical method for assessing, managing, discussing, and reviewing threats to the medication’s quality. The pharmaceutical business and regulators can assess, discuss, manage, and analyze risk with the use of QRM technologies. There are numerous preferred approaches for risk management in the pharmaceutical sector, including FMEA, FMECA, FTA, HACCP, HAZOP, PHA, Together, risk rating, filtering, and statistical tool analysis offer high dependability, improved quality, enhanced safety, and cost savings that result in shorter development times, less waste, and fewer non-value-added procedures.
QRM, ICH Q9, Pharma, Risk Tools, Compliance
