22 Pharmaceutical Technology
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Trends in Manufacturing eBook May 2024 PharmTech.com
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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.