Competency
Most compounding personnel are familiar with the baseline training expectations under USP 797, but competency-related deficiencies remain common, particularly as operational demands increase. As staffing expands, workflows accelerate, and new processes are introduced, training is often one of the first controls to drift. Particular attention should be paid to three recurring vulnerabilities:
- Ongoing competency and retraining: NABP continues to identify deficiencies in ongoing training across both sterile and nonsterile compounding, particularly where retraining is either not documented or not performed at the required frequency. As workflow demands increase, maintaining training cadence and ensuring operational coverage during training becomes more difficult.
- Media-fill design: Media-fill evaluations should reflect the most challenging manipulations performed in practice. This remains a common and readily correctable deficiency. Competency assessments should account for the most complex workflow conditions, including manipulation volume, batch size, and dynamic operating conditions. If using a commercial testing kit, it may need to be adapted to mimic the most complex conditions at your particular facility.
- New equipment and process adoption: Whether implementing Category 3 compounding, introducing new compounding technologies, or transitioning to in-house testing, personnel conducting the testing must be trained and competency-assessed before use. Training for new technology should extend beyond basic operation to include routine maintenance, process verification, and interpretation of resulting data, with documentation maintained throughout.
Closing competency gaps: Standardize training
Standardize your training and automate the training schedule as much as possible. Ensure documents are readily retrievable for inspectors. NABP reports that many times, records were locked and not available during the inspection. Simplifi 797 centralizes education tools and competency tracking. The system tracks completions and flags overdue assessments, giving pharmacy leaders complete visibility into staff readiness and makes records quickly available. This reduces the burden of managing training programs while ensuring that only qualified personnel handle critical compounding tasks.
Operations
Breakdowns in routine process execution remain a common gap, particularly in workflow consistency, environmental monitoring, and cleaning and disinfection practices. SOPs should reflect actual practice: if there is a discrepancy between the SOP and routine practice, either staff need to be retrained, or SOPs need to be updated.
Common operational USP 797 compliance gaps
NABP continues to cite basic but critical lapses, such as failing to disinfect materials with sterile isopropyl alcohol (sIPA) and allow them to dry before transfer into the PEC, using incorrect agents (cleaning, sporicidal, sIPA), missing required USP <797> cleaning frequencies, or failing to follow proper technique. Cleaning and sporicidal agents should also be routinely checked for expiration, with required dwell times consistently observed. While some of these issues may require retraining, more often the problem is not knowledge—it is consistency, oversight, and documentation.
Environmental monitoring presents similar gaps. Common deficiencies include poorly documented sampling locations, missed sampling frequencies based on compounding activity, inadequate follow-up of out-of-specification results, and failure to investigate adverse trends before contamination occurs.
Closing operations gaps: monitor and follow-up
Inspection should not be the first time staff practices are evaluated. Routine observation and workflow audits are essential to identifying and correcting issues early. Beyond these recommendations, consider leveraging established tools rather than relying solely on manual processes. As compounding becomes more complex, manual checks and documentation alone are increasingly difficult to sustain and can create avoidable compliance vulnerabilities.
Simplifi 797 provides immediate access to a peer-reviewed content library of expert-vetted standard operating procedures for USP 797 compliance. You can deploy these ready-to-use templates across your enterprise to save hundreds of hours of development time. The platform also automates task management, prompting staff to complete daily tasks. Managers can view real-time compliance dashboards to ensure no tasks slip through the cracks during busy shifts.
Recordkeeping
Recordkeeping deficiencies are one of the most avoidable findings in compounding facilities. As long as documentation relies heavily on manual processes, missing, incomplete, or inaccessible records will remain a persistent risk. In sterile compounding, documentation is not just administrative—if it is not documented, it cannot be verified.
These deficiencies commonly appear across multiple areas of practice:
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Temperature logs where excursions are not identified in real time due to manual recording; temperature not monitored in all storage areas.
- Certifier reports that are accepted without review of underlying findings or trends; staff neglecting to verify that certifiers documented all necessary information, such as dynamic conditions or number of personnel.
- Outdated master formulation and compounding records
- Undocumented training
- Undocumented accommodations made by the designated person without supporting evidence that the compounding environment was not impacted
- Records exist but are not retrievable when needed
Closing recordkeeping gaps: digitize and centralize
A platform such as Simplifi 797 can reduce many common recordkeeping deficiencies by replacing manual documentation with centralized, readily retrievable records. Automated monitoring can identify excursions in real time, while digitized logs improve control over training, environmental monitoring, record versioning, and designated person documentation. It can centralize MFRs and CRs, and standardize required fields. In practice, tools like this help ensure critical records are not only completed, but accessible when needed.
Environment
Lastly, the environment of the facility itself can be a source of compliance gaps, such as deficiencies in cleanroom design, airflow, pressure differentials, layout, and engineering controls. Common findings include:
- Surfaces were not cleanable, smooth, impervious; or had cracks
- Ceiling tiles not caulked
- Airflow & HVAC issues: failure to maintain pressure differentials; improper location of air returns, or not changing HEPA filters as required
- Improper PEC placement, near high traffic areas
- Design of cleanroom not conducive to streamline workflow, introducing interruptions and contamination risk
Closing environment gaps: oversight
Besides ensuring facility renovations meet USP 797 compliance requirements, the facility should be treated as an ongoing operational responsibility. Surfaces should be routinely inspected for damage and repaired promptly, while ceilings, seals, and finishes should be checked regularly to ensure they remain cleanable and intact.
Airflow and engineering controls require the same level of oversight. Pressure differentials, HEPA maintenance, and certifier findings should be routinely reviewed and documented. Accompany the certifier and ensure they document all necessary information and understand the final certification report. Document any follow up actions after the certification.
Workflow should also be evaluated within the space itself to ensure PEC placement, material flow, and personnel movement support efficient workflow and minimize contamination risk.
Simplifi 797 can support facility oversight by helping pharmacists track the environmental and engineering controls that are often missed between certifications. It also helps ensure facility checks, maintenance intervals, and supporting documentation are completed consistently.
