Volume 2024 | No. 2
SURVEYOR
PCAB COMPOUNDING
Visible residue and white powder on surfaces Inside and outside the hood. Cracks along the outer edge and in the panel or missing panels. n The balances and hot plate/stirrers are very stained and have visible residue. n Of the four ointment mills, one had a torn cover, three had visible residue, and all four had a wool pad underneath that was not cleanable.
TCRX6-G
Overview of the requirement:
Policies and procedures define the contents of the Master Formulation Record (MFR) for every nonsterile and all nonsterile to sterile (“high risk”) compounded preparation or sterile compounded preparations prepared for more than one patient. The MFR requires a minimum of 13 elements. Compliance is assessed through review of the policies and procedures, direct observation of compounding, and response to interviews. Most deficiencies cited incomplete quality control procedures, incorrect compounding instructions, and inconsistencies with BUD assignment.
Comment on deficiencies:
Tips for compliance:
n Calibration:
Maintain daily written or electronic documentation demonstrating compliance with equipment calibration, verification, accuracy measurements, and maintenance requirements. Ensure that the calibration log states the expected frequency for calibration. ٝ .Calibrate equipment periodically as specified by the manufacturer, or annually, as appropriate. .Educate, train, and assess the competency of staff on the process of calibrating equipment. n Temperature, humidity, and pressure differentials: .Ensure temperature sensing devices used to monitor temperature in drug storage areas are all within the appropriate calibration date.
Frequency of citation:
38%
Examples of surveyor findings:
n Master formulation records lack critical detail for someone unfamiliar with the compounding process to produce the compound from start to finish and with the same consistent quality each time. n MFR Issues: .BUDs being assigned inconsistently with USP standards, what was stated on the MFR was not what was stated on the label, and the justification for the BUD Is not accurate for the compounded preparation. .Equipment was not all listed or the instructions lacked calibration of the equipment. .The instructions for compounding the preparation: о Lacked instructions to measure the ingredients. о The instructions did not match the process used to compound the preparation. о Instructions stated to use a specific piece of equipment, and a different piece of equipment was used.
ٝ .Use NIST-certified thermometers and hygrometers to record temperatures and humidity in the buffer and anterooms.
n Cleaning, disinfection/sterilization:
.The pharmacy should ensure that all surfaces of the hood are deactivated, decontaminated, cleaned, and disinfected/sanitized, as appropriate per USP <795>, <797>, and <800> standards. .Operate all hoods with the sash at the proper level, as reported in your certification report. All compounding personnel must know the operational limitations of the equipment used, especially their balances. Ensure that the balances are properly positioned. All of the feet should be in contact with the surface of the direct compounding area. Check to ensure the balance is level prior to each compound, especially if it was moved for cleaning. Know the MAWQ of your balances; refer to USP <1176>. When performing final checks of compounded preparations, ensure the appropriate balance was used based on the MAWQ of the balance.
n Quality control procedures.
The expected quality control Indicators (e.g., color, odor, texture, consistency) were not always stated on the MFR. ٝ .The expected result of the filter integrity test was not stated. ٝ .Lacked verification of the actuation of a dosing dispensing container when dosed by clicks. .No theoretical weight was stated on the MFR for the compounder to compare to when performing weight variation testing. .Particulate visual inspection was not included. .MFR states the quality control testing (e.g., USP <51> test to be conducted but it is not performed. n Observed a pharmacy technician revising an existing MFR instead of making a new MFR which is then reviewed by a pharmacist prior to compounding. There is currently no policy, nor training documented on this procedure.
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