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34 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2024 PharmTech.com Compounding ganizational responsibilities are key in this effort. Management responsibility for calculations perfor- mance with efforts to prevent deficiencies through QRM pr inciples suppor t qua lit y cu lt ure develop- ment—orga n i zat ion s succeed ba sed on ma nage- ment commitment. Acknowledgments Com ments f rom Ja n M. Keresztes, R Ph, Pha r m D, ph a r m aceut ica l educator; Jea n ne Molden h auer, pharmaceutical consultant, Excellent Pharmaceuti- cal Consultants; Richard Poska, RPh, Managing Di- rector, Flexo CMC Consulting, and William R. Porter, PhD, principal scientist, Peak Process Performance Partners, are greatly appreciated. References 1. Ansel, H.C. Pharmaceutical Calculations, 14th edition. Wolters Kluwer/Lippincott, Williams, & Wilkins, Philadelphia, PA, 2013. 2. Teixeira, M. G. and Zatz, J.L. Pharmaceutical Calcu- lations, 5th edition. John Wiley & Sons, Hoboken NJ, 2017. 3. O'Sullivan, T.A. and Albrecht, L.S. Understanding Pharmacy Calculations, 2nd edition. American Phar- macists Association, Washington, D.C., 2014. 4. Saava, M. Pharmaceutical Calculations, A Conceptual Approach. Springer Nature Switzerland AG, Cham, Switzerland, 2019. 5. Morgan, W. Pharmaceutical Calculations. For: NA- PLEX Exam, CPJE, Pharmacy Students, Pharmacy Technicians, Medical Students, Nursing Students. Independently published, 2022. 6. Danquah, M. Pharmaceutical Calculations: 1001 Ques- tions and Answers. Kindle Direct Publishing, IL 2017. 7. Allen, L. V., Jr. Pharmaceutical Compounding Cal- culations in The Art, Science, and Technology of Pharmaceutical Compounding, 6th ed. American Pharmacists Association, Washington, D.C., 2020. 8. Stassi, M. E. and Tiemann, M.A. Math for Nurses, 3rd ed. Kaplan Publishing, New York, 2012. 9. Ferencz, N. Learning and Mastering Pharmaceutical Calculations. ASHP, Bethesda, MD 20814, 2018. 10. Aleccia, J. Nurse's Suicide Highlights Twin Tragedies of Medical Errors. NBC News, June 27, 2011. 11. Gray and White. How Walgreen's Prescription Error Led to Overdose by Baby Caused by Wrong Dose of Medication Drug. Blog post, Feb. 6, 2011. 12. Schencker, L. Jury Awards $3.3 Million in Northwest- ern Overdose Case. Chicago Tribune. Aug. 12, 2016. 13. Pluta, P. L.; Mancini, A.M.; Thakar, N.B.; and Chai- yaperm, V. Pharmaceutical Compounding Calcula- tions in the Workplace Environment. PharmTech.com. Submitted for publication. 14. Suneeta, S. Masks Aggravated Miscommunication Between Doctors Leading to Patient's Overdose Death: Inquest Report. International Business Times, July 16, 2022. 15. ISMP. List of Confused Dug Names. ISMP.org, Febru- ary 2023. 16. ISMP. High-Alert Medication List for Acute Care Set- tings, ISMP.org (accessed Jan. 29, 2024). 17. ISMP. High-Alert Medications in Long-Term (LTC) Settings, ISMP.org (accessed Feb. 14, 2024). 18. ISMP List of High-Alert Medications in Community/ Ambulatory Care Settings, ISMP.org (accessed Feb. 14, 2024). 19. Pennsylvania Patient Safety Authority (PSA). Ad- verse Drug Events with HYDROmorphone: How Pre- ventable Are They? patientsafety.pa.gov, September 2010. 20. ISMP. List of Error-Prone Abbreviations, Symbols, and Dose Designations. ISMP.org (accessed Jan. 29, 2024). 21. ISMP. ISMP Adds Three New Best Practices to its 2022-2023 for Hospitals. ISMP.org. Feb. 10, 2022. 22. Tribble, D. The Illusion of accuracy. ASHP Blog Viewer, March 5, 2019. 23. Jordan, M. A.; Choksi, D.; Lombard,K.; and Patton, L.B. Development of Guidelines for Accurate Measure- ment of Small Volume Parenteral Products Using Syringes. Hosp Pharm, 2021 Jun; 56(3), 165-171. 24. GlobalRxPh. https://globalrph.com (accessed Feb. 23, 2024). 25. MD+Calc. https://www.mdcalc.com (accessed Feb. 23, 2024). 26. ClinCalc.com. https:/clincalc.com/ (accessed Feb. 23, 2024). 27. ISMP. Independent Double Checks: Worth the Effort if Used Judiciously and Properly. ISMP.org, June 6, 2019. 28. FDA. Guidance for Industry. Quality Systems Approach to Pharmaceutical CGMP Regulations (CDER, Septem- ber 2006). 29. ICH. Q10 Pharmaceutical Quality System (ICH, June 4, 2008). 30. FDA. CDER Quality Management Maturity. FDA.gov. Jan. 26, 2024. 31. ICH. Q9(R1) Quality Risk Management (ICH, Jan. 18, 2023). 32. ISMP. First ISMP Targeted Medication Safety Best Practices for Community Pharmacy Released, ISMP. org, Apr, 4, 2023. 33. ISMP. Best Practice 14 in 2018-2019 Targeted Medi- cation Safety Best Practices in Hospitals. ISMP.org. (accessed Jan. 6, 2024). 34. Rush Universit y Hospital Pharmacy, Chicago IL 2018. 35. Hoare, A. The Most Common FDA 483 Observations. Ideagen.com (accessed Jan. 29, 2024). ■