Focus on Quality Assurance: Tips on Meeting Sterile Compounding Standards

Establish Verification Processes

Refer to Section 7: QUALITY ASSURANCE PROGRAM and APPENDIX 12: COMPONENTS OF A QUALITY ASSURANCE PROGRAM

NAPRA hazardous and non-hazardous sterile compounding standards require the sterile compounding supervisor to establish a pharmacy-specific QA program for verification of facilities, equipment and personnel that affect safety and the quality of compounded sterile preparations. This QA program is intended to generate information indicating that the conditions and established procedures required for contamination-free compounded sterile preparations are attained and maintained.

The QA program must have four main components:

Verification of equipment, including the Primary Engineering Control(s)
Verification of facilities, including the clean room and anteroom (Secondary Engineering Controls)
Verification of personnel competency in aseptic compounding processes (e.g., Media Fill Test, GFS, etc.)
Verification of final compounded sterile preparations

TIP: If sterile compounding supervisor responsibilities are shared between more than one registrant, regular and frequent communication is essential to ensure all the sterile compounding supervisor responsibilities outlined in Section 5.1.1.2 are being followed.

Assign Results to Verification Processes

For each of the four main components of the QA program, the results of the verification process must be assigned one of three levels by the sterile compounding supervisor:

Compliance (no action required): mandatory specifications have been attained.
Alert (tendency toward non-compliance): increased vigilance is required to prevent non-compliance.
Action required (non-compliant): more in-depth investigation, immediate corrective action and/or preventive action are needed to avoid return to non-compliance.

TIP: Clearly mark certification and sampling reports with the assigned level of compliance, such as with a stamp or sticker, providing a space for the date and the sterile compounding supervisor to acknowledge that they have reviewed the full report and assigned the result.

Analyze Results

The verifications required by the QA program provide valuable data to allow the sterile compounding supervisor to identify trends concerning microbial load in controlled areas and types of microorganisms found. This allows corrective and preventive actions to be taken, if necessary. When appropriate, the sterile compounding supervisor should consult a microbiologist or infectious diseases specialist.

TIP: If assigning any tasks related to the QA program to other individuals, the sterile compounding supervisor must ensure their competency and the activity (e.g., certification, sampling, data analysis, etc.) is performed correctly. The sterile compounding supervisor remains responsible for all aspects of the QA program including the assigning and analysis of results.

Document and Act on Results

To act on the results of the verification process, the sterile compounding supervisor must have protocols in place to investigate non-compliance and deviations from policies and procedures. These protocols must outline the necessary corrective and preventive actions to achieve compliance.

When corrective measures are implemented to address non-compliance (e.g., additional training, etc.) verifications should be repeated to determine their effectiveness and if additional action may be required. Consultation with a microbiologist or infectious diseases specialist may be necessary.

Written documentation related to the QA program must be retained. This information is made available to, and used by, compounding personnel and other responsible individuals, such as the Designated Manager in a community pharmacy or the pharmacy manager/administrator in a hospital pharmacy.

TIP: Have Quality Assurance meetings with compounding personnel as often as verification results are available or on a regular basis (e.g., quarterly).

Test your knowledge

Use the below educational tool to anonymously test your knowledge of the sterile compounding standards.

All personnel (pharmacists, pharmacy technicians and pharmacy assistants) assigned to the compounding of high-risk sterile preparations must undergo assessment at least:

Once a year

Twice a year