Quality Risk Management for the Evaluation of Potable Water Final Rinse during the Cleaning Process of Granulator Jilter Bags

Abstract

The objective of this article is to describe the application of Quality Risk Management (QRM) approach to assess and manage the risk associated to the impact of using Potable Water during the final rinse process used to clean the exhaust cloth filter bags of the Fluid Bed Granulators at the Plant Y, facility. The Quality Risk Management tools were used to perform a holistic evaluation of the granulation exhaust cloth filters cleaning process performance, the manufacturing function of the filters and also any potential drug product quality attribute impact that could affect patient/customer safety. The resulting Risk priority number (RPN) of 45 for a “negligible” severity, according to QRM methodology, has a “Broadly acceptable” acceptability. “Broadly acceptable” criteria mean that these would be acceptable risks, no further risk control measures needed. No risk/benefit rationale required for acceptance. Key Terms -Cleaning Process, Granulator, Quality Risk Management, Risk Assessment.