Pharmaceutical Technology - May 2024

Pharmaceutical Technology - May 2024

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22 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2024 PharmTech.com KZENON- STOCK.ADOBE.COM Paul L. Pluta, RPh, PhD, is a pharmaceutical scientist. Alan M. Mancini, RPh, is a pharmaceutical scientist. Nishant B. Thakar, RPh, PharmD is assistant professor Clinical Sciences, Roosevelt University College of Science, Health, and Pharmacy. Varanya Chaiyaperm, RPh, PharmD is clinical assistant professor, University of Illinois College of Pharmacy. Pharmaceutical Compounding Calculations in a Workplace Environment An ordered process describing calculations activities for compounded dosage forms is described. M athematic calculations are a critical activity in pharmaceutical compounding. All com- pounded preparations will require calcu- lations at some time during their lifecycle. Types of calculations are many and varied—basic math, drug concentration, dose adjustments, batch size changes, stability testing, and many others—all of which require human performance. This discussion describes the following series of activities to execute calculations for preparation of compounded dosage forms: • Stage 1 equation design. Work prior to actual calculations; integrating information, resolving inconsistencies, equation set-up, and initiating documentation. • Stage 2 numeric operations. Equation execution, result evaluation, and completing documentation. • Stage 3 independent review. Verification of in- formation, calculations, and documentation • Management responsibilities. Key activities, personnel, priorities, and workplace culture. Activities described address performance in the workplace environment. These may be performed by an individual person in a 503A pharmacy or by mul- tiple people in 503B outsourcing facilities, pharma industry, and other settings.

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