European Medicines Agency, Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance Problems, EMA/590745/2012.
WHO, Medicines shortages: global approaches to addressing shortages of essential medicines in health systems, WHO Drug Information, Vol. 30, No. 2, 2016
Woodcock J, Wosińska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther. 2013;93(2):170–6.
Yu LX, Kopcha M. The future of pharmaceutical quality and the path to get there. Int J Pharm. 2017;528(1-2):354–9.
U.S. Food and Drug Administration. Drug shortages: root causes and potential solutions. 2019. https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions.
Yu LX, Raw A, Wu L, Capacci-Daniel C, Zhang Y, Rosencrance S. FDA’s new pharmaceutical quality initiative: knowledge-aided assessment & structured applications. Int J Pharm X. 2019;1:100010.
CAS PubMed PubMed Central Google Scholar
O’Connor TF, Yu LX, Lee SL. Emerging technology: a key enabler for modernizing pharmaceutical manufacturing and advancing product quality. Int. J Pharm. 2016;509(1-2):492–8.
Fisher AC, Lee SL, Harris DP, et al. Advancing pharmaceutical quality: an overview of science and research in the US FDA’s office of pharmaceutical quality. Int J Pharm. 2016;515(1-2):390–402.
Juran J, Godfrey AB. Juran’s quality handbook. New York: Mc Graw Hill; 1999.
Sam AP, Koch H. Quality metrics, quality culture, quality matters! Industrial Pharmacy Issue. 2014;44:18–22.
Torkko M, Katajavuori N, Linna A, Juppo AM. The utilization of quality KPIs in the pharmaceutical industry. J Pharm Innov. 2014;9:175–82.
Friedli T, Köhler S, Buess P, Basu P, Calnan N. FDA quality metrics final report. 2017.
Friedli T, Köhler S, Buess P, Basu P, Calnan N. FDA quality metrics final report year 2. 2018.
Friedli T, Köhler S, Buess P, Basu P, Calnan N. FDA quality metrics final report year 3. 2019.
FDA-CDRH’s Case for Quality. (Retrieved March 18, 2022: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality).
Woodcock J. Plenary Address at the 2014 PDA/FDA Joint Regulatory Conference October 2014. (Retrieved March 18, 2022: https://www.youtube.com/watch?x-yt-ts=1422503916&v=QUNbDSRPUhU&feature=player_detailpage&x-yt-cl=85027636).
FDA Quality Management Maturity Pilot Programs for Finished Dosage Forms and Active Pharmaceutical Ingredients, dated October 15th, 2020. (Retrieved March 18, 2022: https://www.fda.gov/drugs/development-approval-process-drugs/pharmaceutical-quality-resources).
Patel P, Baker D, Burdick R, Chen C, Hill J, Holland M, Sawant A. Quality culture survey report. PDA J Pharm Sci Technol. 2015;69(5):631–42. https://doi.org/10.5731/pdajpst.2015.01078.
Article CAS PubMed Google Scholar
Points to consider: Pharmaceutical Quality Metrics Updated September 2014. PDA Journal of Pharmaceutical Sci and Tech. 2014. Vol. 68, No. 5, September – October 2014.
ISPE Advancing Pharmaceutical Quality Guides: Change Management System (Retrieved March 18, 2022: https://ispe.org/publications/guidance-documents/apq-guide-change-management-cm-system); Corrective Action and Preventive Action (CAPA) System (Retrieved March 18, 2022: https://ispe.org/publications/guidance-documents/corrective-action-preventive-action-capa-system); Management Responsibilities and Management Review (Retrieved March 18, 2022: https://ispe.org/publications/guidance-documents/apq-guide-management-responsibilities-review-mrr).
Proposals for FDA Quality Metrics Program - Whitepaper. IPSE. 20 December 2013. (Retrieved March 18, 2022: https://ispe.org/sites/default/files/training/quality-metrics-proposal.pdf).
Elder D, Teasdale A. “ICH Q9 quality risk management”, ICH quality guidelines: an implementation guide. 2017 pp 579-610.
Ho SK, Cicmil S, Fung CK. The Japanese 5-S practice and TQM training. Train Qual. 1995;3(4):19–24. https://doi.org/10.1108/09684879510098222.
Cua KO, McKone KE, Schroeder RG. Relationship between implementation of TQM, JIT, and TPM and manufacturing performance. J Operations Manag. 2001;19:675–94.
Floyd RC. Liquid lean – developing lean culture in the process industries.
Dean JW, Bowen DE. Management theory and total quality: improving research and practice through theory development. Acad Manag J. 1994;19:392–418.
MacDuffie JP. Human resource bundles and manufacturing performance: organizational logic and flexible production systems in the world of auto industry. Ind Labor Relat Rev. 1995;48:197–221.
FDA. Guidance for Industry Q10 Pharmaceutical Quality System. 2009: https://www.fda.gov/media/71553/download. Accessed 1 Sep 2022.
Jain SK, Jain RK. Investigations and CAPA: quality system for continual improvement in pharmaceutical industry. Int J Res Pharm Pharm Sci. 2017;2:47–54.
留言 (0)