Tablets & Capsules

TC0717

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Tablets & Capsules July 2017 23 References R. Mestel, "The Colorful History of Pills Can Fill Many a Tablet," Los Angeles Times, Mar 25, 2002. "Guidance for Industry: PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), Pharmaceutical CGMPs, September 2004. "Pharmaceutical cGMPs for the 21st Century: A Science and Risk Based Approach." FDA. Online. Accessed May 25, 2017. M. Glodek et al., "Process Robustness–A PQRI White Paper," Pharm Eng 2008 26(26): 1-11. R. Iser and A. Srinivasan, "FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 1: Drug Substance," Pharm Tech 2010 34:1. J. Piriou, B. Elissondo, M. Hertschuh, and R. Ollivier, "Control Strategy as the Keystone of the Product Lifecycle, from Product/Process Understanding to Continuous Process Verification and Understanding," Pharm Eng 2012 2(1): 1-8. J.F. Skaftason and T. Johannesson, "Tablets and Tablet Production–with Special Reference to Icelandic Conditions," Laeknabladid 2013 99(4): 197-202. G.A. Van Buskirk et al, "Best Practices for the Development, Scale-up and Post-Approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm," AAPS PharmSciTech 2014 15(3): 665-693. LX Yu et al, "Understanding Pharmaceutical Quality by Design," AAPS J 2014 16(4): 771-783. T. Mire-Stuis, B. Kuhn, and T. Monica, "Development of Integrated Control Strategies and PV Plans for US and European Filings," CASSS CMC Strategy Forum Europe, 2014. S. Pope-Miksinski, "Regulatory Considerations in the Development and Communication of Control Strategy," CMC Workshop, ONDP, FDA, 13 April 2015. S. Pope-Miksinski, "Integrated Quality Assessment: An Update on Team-Based and One Quality Voice," DIA CMC Workshop, ONDP, FDA, 14 April 2015. R. Iser, "Life-Cycle Management–FDA Perspective," Office and Process and Facilities, OPQ, FDA, DIA CMC Workshop, April 13-15 2015, Bethesda, MD. Risk Ranking and Filtering, PQRI, Risk Management Training Guides, Manufacturing Technology Committee– Risk Management Working Group, pp 1-8. Robert J. Timko, RPh, PhD, is president of RhoTau Pharma Ser- vices, 920 Sassafras Circle, West Chester, PA 19382. Tel. 484 437 2654. Website: www.RhoTauPharma.com. His consulting work focuses on helping companies optimize their development and supply chain footprints leading to successful product commercialization. He has more than 40 years of industry experience in developing a variety of dosage forms from both pharmaceutical development and regula- tory affairs perspectives. Further reading To find more information about the topics discussed here, search for articles listed under "Excipients," "Formulation," and "Quality by Design" in Tablets & Capsules' article index in the November 2016 issue and at T&C's website, www.tabletscapsules.com. e xperts alik s and e beginner ͕ ŵ Ă Ğ ƚ Ő Ŷ ŝ ƌ Ƶ ƚ Đ Ă Ĩ Ƶ Ŷ Ă ŵ Ğ ƌ Ɵ Ŷ Ğ Ğ Ś ƚ ƌ Ž & -learning E sule Cap & t able Table erful w o P T Individuals or groups can select on-line training topics and training topics and ƌĞĐĞŝǀĞĂĐĞƌƟĮĐĂƚĞ ŽĨĐŽŵƉůĞƟŽŶ ƚĞĐŚĐĞƵƟ ƟĐĂůƐ͘ĐŽŵ

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