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Pharmaceutical Technology Regulatory Sourcebook October 2020 25 ment of the product and the process, needs to be generated and improved with process scale-up. These inputs define the commercial manufactur- ing process that is verified during process perfor- mance qualification. The qualification only relies on a small number of batches and, for this reason, the evidence of the control of the process, and hence of the quality of the product, needs to be verified in the following stage with specific moni- toring strategies. Quality-by-design concepts and risk management are enablers of this approach allowing the identification and assessment of the critical aspects with respect to process parameters, material attributes, and product quality attributes, ultimately ensuring the manufacture of a product meeting all the desired targets in terms of quality and safety. Disclaimer This article reflects the views of the authors and should not be construed to represent any pharmaceutical company's or regulatory agency's views or policies. References 1. ICH Q8 (R2) Pharmaceutical Development, step 4 version (2009). 2. L.X. Yu, Pharm. Res., 25 (4) 781–791(2008). 3. FDA, Process Validation: General Principles and Practices Process (Rockville, MD, Jan. 2011). 4. FDA, Quality by Design (QbD): An Example Pharmaceutical Devel- opment Report for an Immediate Release (IR) Dosage Form (2012). 5. S. Anwer, et al., IOSR J. Pharm. & Biol. Sci., 9 (1) Ver. IV 67–74 (2014). 6. ICH, Q10 Pharmaceutical Quality System, step 4 version (2008). 7. EMA, Guideline on Process Validation for Finished Products—Infor- mation and Data to be Provided in Regulatory Submissions (London, UK, Nov. 2016) 8. G.E.P. Box and N.R. Draper, Empirical Model-Building and Response Surfaces (John Wiley & Sons, New York, 1978). 9. J. F. MacGregor and T. Kourti, Control Eng. Practice, 3 (3) 403–414 (1995). 10. S. Wold, M. Sjöström, and L. Eriksson, Chemom. Intell. Lab. Syst., 58 (2) 109–130 (2001). 11. J. E. Jackson, A User's Guide to Principal Component (John Wiley & Sons, New York, 1991). PT Get help with Pharma Marketplace. Pharma Marketplace gives you all the information you need to choose the right supplier. Our directory quickly connects you with bio/pharmaceutical companies around the world. pharmtech.com/marketplace How do you choose the right supplier? ADVANCING DEVELOPMENT AND MANUFACTURING Brought to you by PT-HouseAd-2020-horizontalhalf.indd 1 7/20/2020 9:09:31 AM