Vol. 4, Issue 4 (2019)
Quality risk management in manufacturing of oral dosage formulations
Author(s): Rakesh Patel, Neetu Choudhary, Raju Choukse, Vikas Jaiswal, Nehal Sharma
Abstract: The risk management program consists of four major components: risk assessment, risk control, risk review, and risk communication. All four components are essential. All the above methods should address the mentioned four basic components. Team selection and method selection are also plays a vital role in the risk management process, so care should be taken while selection of risk management team and method. FMEA/FMECA is the preferable method for risk management in the pharmaceutical industry as FMEA analysis include higher reliability, better quality, increased safety and its contribution towards cost saving includes decreased development time and reduced waste and non-value added operation.