PAT & QbD SUPPLEMENT A process signature derived from process analytical technology such as NIR
coupled with the process sensors (i.e. temperature, pressure, humidity, etc.) is more powerful to detect equipment deficiency or drift and allow triggering an action during the process, thus avoiding batch failure or batch rework.
Benefits This example shows the benefit of using the NIR-Diffuse Reflectance probe as a PAT tool for real-time monitoring of the granulation process during API spraying and drying.
The NIR technology allowed: better understanding in real-time of the granulation process during the spraying phase
monitoring of the loss on drying %w/w level to detect the drying endpoint in real-time
reduction of In-Process Monitoring (IPM) / In-Process Control (IPC) sampling for LOD measurements
prevention of batch failure and rework improvement to the consistency in the level of LOD at the drying endpoint between batches
Conclusion PAT is continuously proving its long-term benefits in the pharmaceutical industry from a quality perspective as well as a business, ergonomic and environmental perspective. Its implementations on the manufacturing scale have been facing both technical and cultural challenges. Technical challenges are more related to the infrastructure for data management systems, automation systems, associated with the relatively high short term costs of implementing PAT technologies and the QbD approach versus its high benefits long term. Cultural challenges are more related to the need to change management structure so as to introduce new functions for implementing these approaches. Another cultural challenge is the integration of PAT in the quality management system for routine control and batch release which has not yet reached a mature level. Despite these challenges, with the continuous work of the regulatory
agencies in developing the various guidelines for industry to encourage implementation of QbD and PAT, the future of PAT is assured. PAT is increasingly becoming the basis for innovations and continuous improvements of process under standing and control which will in fact give higher confidence in product quality, improving the quality of submissions and hence providing the opportunity for a more flexible regulatory approach.
References
1. Guidance for Industry. PAT – A framework for innovative pharmaceutical development, manufacturing and quality assurance. Food and Drug Administration. September 2004
2. Thomas P., Leveraging PAT and QbD promises significant environmental dividends.
PharmaManufacturing.com , the digital resource of pharmaceutical manufacturing magazine
3. ICH harmonised tripartite guideline pharmaceutical development Q8(R2), Step 4 version, August 2009
Dr Magida Zeaiter has a PhD in Process Engineering, Applied Mathematics and has been working in the Research & Development Department at GlaxoSmithKline UK since November 2004. She has been applying Process Analytical Technologies (PAT) in GSK for process understanding, monitoring and control. She worked in both chemical and pharmaceutical departments for drug substance and drug product development of oral solid dose as well as respiratory (inhaled and intranasal) formulations. She also worked on the inhaled medical device manufacturing process.
email:
magida.w.zeaiter@gsk.com www.europeanpharmaceuticalreview.com
European Pharmaceutical Review Volume 16 | Issue 3 | 2011
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