Pharmaceutical Technology - May 2024

Pharmaceutical Technology - May 2024

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28 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2024 PharmTech.com Compounding fade over time. Online calculations applications (24–26) may be used to confirm calculated values but must not be the primary method of execut- ing calculations. Execute equations–actual numeric calculations. After appropriate equations are set up, numeric oper- ations are executed. Most critical in this activity is the writing of units of measure in equations. Individual units of measure are cancelled in equations. Correct numeric entry into a calculator is critical; humans op- erating calculators may make data entry errors. Cal- culations must not be copied from previous approved equations—previous calculations may not be correct. Clear, concise, and legible calculations documentation is mandatory (Figure 3). Result evaluation. After calculations are completed, calculated values are evaluated. The original medica- tion order information is reviewed; the Stage 1 esti- FIGURE 2. Calculations Record — Sterile Compounding. Calculations Record for Sterile Compounding. Procedure # Stage 1 Equation Design Patient name: Bed # Patient # Date: Patient information: Medication order Dosage form to be prepared: Route of administration Calculation objective Calculation estimate Drug name, dosage strength, NDC # Expiration/BUD Precautions (high alert drugs, intrathecals, calcium phosphate) with references. Equations Stage 1 Accountability Stage 2 Numeric Operations Calculations Calculations evaluation Stage 1 Accountability (Name, date) Stage 1 additional verification (if necessary) (Name, date) Stage 2 Accountability Stage 2 Accountability (Name, date) Stage 2 additional verification (if necessary) (Name, date) Stage 3 Independent Verification Attach checklist # Review evaluation Stage 3 Accountability (Name, date) Stage 3 additional verification (if necessary) (Name, date)

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