This article discusses how the application of NIR spectroscopy in mix process development optimizes the process knowledge, allows for addition of DoE to generic products, improves transdermal product manufacturing processes, reduces process development and scale-up timelines, and accelerates market-reach time.
A number of guidance documents have been released by the FDA in the past several years in order to promote the implementation of Quality by Design (QbD) components by companies into different stages of their product life cycles, with product development as the main area of focus. Fundamental QbD elements are expected to be included in ANDA product filings by companies, starting in the year 2013.
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released guidance such as Q8 {R2) Pharmaceutical Development, Q9 Quality Risk Management, and Qio Pharmaceutical Quality System to direct companies in this initiative.
ICH Q8 (R2) defines the scope and principles of QbD and provides examples and approaches to improve process and product knowledge in the development of processes and formulations. ICH Q9 describes the implementation of quality risk management into product development with the help of scientific information to perform risk assessments. ICH Qio describes how ICH QB and ICH Q9 principles can be used in regulatory strategies.
This information has been sourced, reviewed and adapted from materials provided by Bruker Optics.
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