Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
TCRX6-E Frequency of the citation: 33%
■ Comprehensive understanding of equipment operating parameters is critical to the compounding process. Compounding personnel must maintain daily written or electronic documentation demonstrating compliance with equipment, calibration, verification, accuracy measurements, and maintenance requirements on the days the equipment is used. ■ Policies and procedures address, at a minimum: ٝ Manufacturer’s recommendations.
Nerd Newbies (understand the requirement)
Overview of the requirement: The pharmacy follows established policies and procedures outlining the use, calibration, cleaning, and disinfection/sterilization of equipment used throughout the compounding process. Comment on deficiencies: Compliance is assessed through direct observation, response to interviews, and review of policies, procedures, and manufacturers’ instructions. Many deficiencies were specific to balances used for weighing ingredients. Surveyors also noted a lack of consistency with device testing and equipment calibration.
ٝ Storage minimizing the risk of contamination. ٝ Calibration that states frequency and findings.
ٝ Cleaning, disinfection, and/or sterilization procedures and schedules. ٝ Use, calibration, maintenance, and accuracy testing of ACDs (applies to sterile compounding only). ٝ Monitoring devices (e.g., temperature, humidity, pressure) verified for accuracy at least every 12 months or as required by the manufacturer, whichever is more frequent. ■ Confirm compliance with manufacturers’ manuals and guidelines for all applicable equipment. ■ Check humidity measuring devices, pressure gauges, and temperature devices for accuracy. Document results with actual numbers/figures and not simply a pass/fail. Implement corrective actions when out of range. ■ Record repeater pump calibration in the compounding record or on a log identifying the repeater pump by the serial number used. ■ Use checklists, calendar reminders, and logs to ensure consistency. ■ Institute a schedule of frequent observation of all personnel to ensure that they are working within the operational parameters of their equipment. ■ Focus on training and competencies related to balances, as they are the foundation of the compounding process. ٝ Confirm weights used for calibration are certified. ٝ Educate staff that MAWQ is addressed in USP <1176> and how to calculate the MAWQ for the balances in the pharmacy. ٝ Label each balance with the MAWQ. ٝ Modify MFRs and CRs to include the calibration of the equipment to be used and the results of the calibration.
Examples of ACHC Surveyor findings: ■ Equipment not calibrated within the required time frames:
ٝ Devices used to monitor and record temperature and humidity. ٝ Bubble point integrity test pressure gauges. ٝ Compounding equipment, such as mixers, balances, and pH meters.
Nerd Apprentices (audit for excellence)
ٝ Automatic Compounding Device (ACD) (e.g., TPN compounders, repeater pumps). ■ Deficiencies related to balances and minimum accurate weighable quantity (MAWQ): ٝ During observation of compounding, the balance was not leveled. All four legs were not touching the deck/worksurface. ٝ Upon interview, compounding personnel did not know the minimum accurate weighable quantity (MAWQ) for their balances. ٝ The pharmacy did not have an MAWQ assigned to the balances used to weigh ingredients. ٝ The pharmacy uses a MAWQ that is not compliant with USP <1176>. ٝ Calibration of balances is performed using weights that have not been certified. ■ Hot plates and stirrers are tested annually for temperature, but there is no threshold for passing or failing. There is no requirement to follow up when they repeatedly do not perform as expected.
Nerd Trailblazers (prepare the path for others)
achc.org | (855) 937-2242 | 23
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