Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 475, Issue 1-2, Pages 245-255Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2014.08.055
Keywords
Quality by design; Process understanding; ICH Q9?quality risk management; Computational simulation; Discrete element method; Tablet coating
Categories
Funding
- Austrian COMET Program, under the auspices of the Austrian Federal Ministry of Transport, Innovation and Technology (bmvit)
- Austrian Federal Ministry of Economy, Family and Youth (bmwfj)
- State of Styria (Styrian Funding Agency SFG)
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The purpose of this study is to evaluate the use of computer simulations for generating quantitative knowledge as a basis for risk ranking and mechanistic process understanding, as required by ICH Q9 on quality risk management systems. In this specific publication, the main focus is the demonstration of a risk assessment workflow, including a computer simulation for the generation of mechanistic understanding of active tablet coating in a pan coater. Process parameter screening studies are statistically planned under consideration of impacts on a potentially critical quality attribute, i.e., coating mass uniformity. Based on computer simulation data the process failure mode and effects analysis of the risk factors is performed. This results in a quantitative criticality assessment of process parameters and the risk priority evaluation of failure modes. The factor for a quantitative reassessment of the criticality and risk priority is the coefficient of variation, which represents the coating mass uniformity. The major conclusion drawn from this work is a successful demonstration of the integration of computer simulation in the risk management workflow leading to an objective and quantitative risk assessment. (C) 2014 Elsevier B.V. All rights reserved.
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