ABSTRACT

The Pharmaceutical Quality Research Institute Manufacturing Technology Committee (PQRIMTC) has appointed a risk management task force to coordinate industry case schedule to improve understanding and applicability of ICH Q9. The ICH Q9 guidance will help the industry get started with risk management plan, implementation and practice seems to be challenged. Quality Risk Management (QRM) approach, established by regulatory agencies with accredited management tools, allows for a riskbased advanced towards to quality management in conjunction with statistical tools, which ensures that resources are utilized in accordance with Good Manufacturing Practice (GMP). This article describes to analyze risk for a quality organization and guidance the way to achieve quality management and observation through quality risk management. Keywords: Quality risk management, Good manufacturing practice, Implementation, Tools, Process, Technology transfer
Publication date: 01/10/2022

https://ijbpas.com/pdf/2022/October/MS_IJBPAS_2022_6484.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.10.6484