Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development

Application of Quality by Design Principles to the Development of Oral Lyophilizates Containing Olanzapine

“…The results of the risk assessment enabled identification of critical factors—CMA and CPP, which affect CQA. The aim of CMA and CPP identification is to prevent the implementation of unnecessary and inefficient phases in the development process [ 3 , 11 , 14 , 15 ].…”

“…It facilitates the establishment of the design space, i.e., the multidimensional combination and interaction of factors that have been shown to provide quality, and specifies information on the values of the factors within which the desired values of responses can be expected [ 12 , 13 ]. Quality risk management is a systematic process of assessing, monitoring, communicating, and reviewing pharmaceutical product quality risks throughout their entire life cycle and begins with risk assessment [ 11 , 14 ]. Risk assessment (the combination of the probability of an event and the severity of the damage it may cause) is based on scientific principles, and its main goal is to ensure patient safety.…”

“…Failure mode and effects analysis (FMEA) is one of the tools for methodologically assessing, understanding, and documenting potential risks to a process and product quality. It is used for the purpose of quantitative risk assessment, which allows for the identification of factors that are most likely to adversely affect the product and/or its manufacturing process [ 14 ].…”

<p>QbD-Based Investigation of Dermal Semisolid in situ Film-Forming Systems for Local Anaesthesia</p>

“…[20][21][22] QbD tools are applied to examine the most critical parameters. 23,24 These tools are summarized in the ICH guideline Q9. 25 Based on our previous research, in situ FFSs could be a good choice to ensure painless local anaesthesia.…”

Investigation of passive and active permeation enhancement methods on skin permeation

“…The QbD concept involves identifying the quality target product profile (QTPP), the critical material attributes (CMAs), the critical process parameters (CPPs), and the critical quality attributes (CQAs) of the product at the beginning of the development [51,56,57]. Several quality tools are applied to examine the most critical parameters and facilitate RA, such as the Ishikawa diagram, Pareto analysis, and risk estimate matrix (REM) [19,58,59].…”