Volume 2024 | No. 2
SURVEYOR
PCAB COMPOUNDING
SECTION 6: PROVISION OF CARE AND RECORD MANAGEMENT TCRX6-C
TCRX5-G Overview of the requirement:
Written policies and procedures are established and implemented regarding continuous quality control for finished preparations. Compliance is evaluated through review of policies, observation, and response to interviews. Most deficiencies resulted from incomplete policies and procedures for testing, as well as a lack of follow through when testing does not meet the requirements.
Overview of the requirement:
Policies and procedures are written to support safe storage, labeling, handling, and disposal of pharmaceutical components and preparations. Compliance is assessed through direct observation, interviews, and review of policies and logs. Deficiencies noted improper storage, insufficient cleaning practices, and incomplete documentation of environmental controls.
Comment on deficiencies:
Comment on deficiencies:
Frequency of citation:
28%
Frequency of citation:
44%
Examples of surveyor findings:
n The pharmacy’s policy on testing lacks: The acceptable limits of the test.
Examples of surveyor findings:
n Storage: ٝ . Written policies and procedures were not established and implemented relating to the storage of pharmaceuticals, components (including APIs, excipients, ingredients, and devices) and compounded preparations. .The expiration date was extended in the compounding software when products were expiring before the assigned BUD for the compounded preparation when the product was needed to complete a compounded preparation. There was no process in place that required compounding personnel to verify a product’s labeled expiration date to ensure its accuracy in the compounding software system and that it was not altered. ٝ .Active and inactive ingredients being stored on the floor along with corrugated cardboard boxes being permanently stored in the compounding area. .Hazardous APIs and antineoplastic hazardous medications that required further manipulation were not stored separately from other non- hazardous items. .The date of transfer was missing on the label of smaller storage containers when used to transfer ingredients from larger containers. n Cleaning and disinfection: ٝ . Reusable containers (e.g., glassware, speed mixer jars) are cleaned and washed in the dishwasher, but there is no disinfection (or sanitization) step. ٝ . Cleaning agents used are not listed on the cleaning logs and the logs are also consistently missing dates and signatures. .A nonsterile HD room was observed being mopped using a reusable household sponge mop using a ready-to-use solution that was randomly diluted when no further dilution was needed. .A negative pressure C-SEC was observed to have extensive amounts of dust and cobwebs. n Temperature and humidity are not monitored and/or documented daily on days the facility Is opened or via a continuous recording device in all drug storage areas, including will-call area and each room of a cleanroom suite.
ٝ .Specific actions required when a preparation does not meet the test. .How quality control information is incorporated into the pharmacy’s PI Program. .Frequency of required testing for sterile and nonsterile preparations. n The compounder’s finished preparations are not tested for potency in each of the dosage forms they prepare: solutions, suspensions, capsules, tablets, suppositories, creams/ointments, and lozenges. n The pharmacy makes some preparations on a weight/weight basis and dispenses using a volumetric device. The pharmacy did not have evidence that the device is accurately dispensing the stated mg amount. n Quality control (QC) testing is not being used to improve the performance of staff. Several potency tests for formulas made by the compounding staff have not been thoroughly investigated as quality related events (QREs). n Implement a testing or quality control program to verify the quality of preparations and the competency of personnel. Include: ٝ . When to test preparations. .What test(s) should be performed. .How to interpret the test and acceptable limits. ٝ .Specific actions required when a compounded preparation does not meet the test. .How quality control information is used to improve the performance of personnel. .How quality control data is incorporated into the PI Program. n Develop an SOP governing QREs and adhere to the process of investigation and resolution. Document any out of specification results and actions taken. n Test the dispensing devices to assure accuracy of dispensing for formulas made as mg/gram and dispensed as an mL dose. Evaluate the bases used and concentrations of added ingredients. n Document potency testing of the compounder’s finished preparations in every dosage form they prepare.
Tips for compliance:
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