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PharmTech.com Trends in Manufacturing eBook May 2024 Pharmaceutical Technology ® 31 Compounding tions personnel must have numeric and mea- surement system skills. Most pharmaceutical calculations do not require advanced mathe- matics; personal characteristics including or- ganizational skills, self-discipline, attention to detail, legible handwriting, and common sense are desired traits for calculations personnel. Re- alizing deficiencies (i.e., what you don't know) is desirable. Some organizations screen prospec- tive employees with a basic mathematics test before hiring (34). • Procedures. Management is responsible for procedures that are useful in daily workplace activities. Compounding organizations must have written and approved SOPs; compliance with procedure requirements is mandatory. In- adequate procedures, training, and non-com- pliance with procedures are always among the most frequent GMP violations in pharma (35). SOP content must be foref ront in compound- ing organization performance. SOPs provide management expectations and minimize per- formance variation. SOPs should be living doc- uments, periodically reviewed for accuracy and relevance, and updated when new information is available. • Training. Personnel must be trained and regu- larly re-trained on SOPs. Training must be doc- umented; if not documented, it didn't happen. Training must emphasize personal accountabil- ity for SOP requirements; personnel must under- stand that their signature/date throughout the calculations process affirms personal respon- sibility. Compliance with procedures must be emphasized in personnel training; compliance must be understood as a bedrock principle. • Commitment. Beyond hiring, procedures, and training are the daily expressions of manage- ment com m it ment to qua l it y. Ma nagement focus must expand from traditional manage- ment to include anticipation of performance hazards (i.e., what might go wrong), per ICH Q 9(R1). The workplace environment must en- courage communication of problems, mistakes, and issues without fear of punishment or embar- rassment. Management must develop a collabo- rative relationship with staff with ongoing focus on quality (i.e., a true quality culture that is evi- dent in personnel performance). Compounding activities are performed primarily by employees; management must be committed to continual training, development, and employee support. Potential calculations hazards. Addressing the following hazards is the responsibility of manage- ment as part of personnel development and organi- zation improvement: FIGURE 4. Example calculations verification checklist. Medication Order 1. Are calculations consistent with original medication order—patient information, drug, dosage, etc.? 2. Did any information require changes, confirmation, or have other problems? 3. Does order involve high-alert drugs, LASA drugs, low-dose drugs, or other known problem drugs? 4. Are specified drugs for calculations consistent with patient diagnosis? 5. Have patient data (age, weight, etc.) been confirmed? Equations 1. Are drug names fully written (no abbreviated names) and use tall-man lettering? 2. Are leading and trailing zeros correctly used? 3. Are units of measure written for all numeric values? 4. Is this a new calculation or a repeated calculation? 5. Are units of measure–especially problematic units such as mcg, units, grains–confirmed? Numeric Operations 1. Are numbers verified to be free of number-transpositions? 2. Have correct numbers be entered into calculation device? 3. Are significant figures correctly used in calculations? 4. Are units of measure cancelled in equations to yield the final calculated value? 5. Are calculated values consistent with expected drug dosages, estimates, or online calculations? Documentation 1. Is all relevant information clearly explained in Calculation Record? 2. Are signatures/dates of all individuals contributing to the calculations process in Calculations Record?