30 Quality Assurance Verification
Ensuring the quality, safety, and consistency of non-sterile compounded preparations is a cornerstone of pharmacy practice. We have already discussed what QA is and why it’s important. This chapter focuses on how to verify QA is being followed. QA verifications are structured, documented activities that assess compliance with established compounding policies, procedures, and regulatory expectations. This chapter will guide you through the key QA verification areas, explain how to determine levels of compliance, and introduce tools to support continuous quality improvement in the compounding process.
Key QA Verifications Required
Below are the major areas of QA verification in non-sterile compounding. Each area plays a critical role in ensuring safe and effective compounding practices.
1. Personnel Training and Competency
Before anyone participates in compounding activities, they must be adequately trained and deemed competent. Ongoing education and assessment help maintain safe practices and reduce errors.
- Initial skills validation
- Annual competency reassessments
- Training on updated SOPs
2. Facility and Equipment Maintenance
A clean, controlled, and functional workspace is essential for compounding. Equipment must be properly maintained to ensure accurate and safe preparations.
- Cleaning logs
- Equipment calibration records
- Environmental monitoring (e.g., air quality)
3. Compounding Process Control
Compounding activities must strictly follow Master Formulation Records and be documented accurately in Compounding Records to ensure reproducibility and traceability.
- Record audits
- Beyond-use date (BUD) and labelling checks
- Verification of weighing and measuring procedures
4. Product Quality Control Checks
Each compounded product must undergo QC checks appropriate to its dosage form. These checks ensure the product meets predefined standards before it is dispensed.
- Physical inspections, including appearance and volume and weight checks
- pH testing, weight variation testing, calculations of yield, when appropriate
- Visual checks for contamination or inconsistencies
5. Risk Assessment Reviews
Each compounded preparation must be evaluated for its risk level (A, B, or C), and the pharmacy’s practices must align with the risk classification.
- Documentation of risk levels
- PPE compliance checks
6. Policy and Procedure Compliance
QA depends on adherence to up-to-date and clearly written SOPs. Verifications ensure staff understand and follow approved procedures.
- SOP reviews
- Staff acknowledgements of policies
7. Incident Reporting and Follow-Up
Incidents and deviations must be tracked and analyzed. This ensures that problems are not repeated and that CQI measures are taken.
- Incident logs and root cause analysis
- Corrective and Preventive Action (CAPA) documentation
8. Recall Procedures
Pharmacies must be prepared to respond quickly and effectively in the event of a recall. Mock recalls test this readiness.
- Established recall protocols
- Documentation of exercises and real recalls
9. Cleaning and Environmental Controls
Clean and controlled environments prevent contamination and protect staff. Regular verifications ensure these practices are not overlooked.
- Surface cleaning logs
- Waste management protocols
| QA Verification Area | Requirements | Examples |
| Personnel Training and Competency | Ensure all compounding personnel complete initial and ongoing training and skills assessments. | – Initial skills validation – Annual competency reassessments – Training on updated SOPs |
| Facility and Equipment Maintenance | Confirm that compounding areas and equipment are properly maintained, cleaned, and calibrated as scheduled. | – Cleaning logs – Equipment maintenance and calibration records – Environmental monitoring results (e.g., air quality if applicable) |
| Compounding Process Control | Validate that each compounded preparation follows Master Formulation Records and Compounding Records accurately. | – Compounding record audits – BUD and labelling checks – Weighing and measuring verifications |
| Product Quality Control Checks | Perform checks specific to the type of compounded preparation. | – Physical inspections (e.g., uniformity of capsules, absence of contamination) – pH testing for aqueous solutions – Weight variation testing for capsules or tablets |
| Risk Assessment Reviews | Ensure risk assessments are conducted for each compounded preparation and updated as needed. | – Check documentation of risk levels (A, B, C) – Confirm appropriate PPE use based on risk category |
| Policy and Procedure Compliance | Verify that compounding follows the pharmacy’s approved SOPs and that policies are updated regularly. | – Policy review records – Staff sign-off on SOPs |
| Incident Reporting and Follow-Up | Review records of any compounding incidents, errors, or adverse events, including corrective actions taken. | – Incident logs – CAPA (Corrective and Preventive Action) documentation |
| Recall Procedures | Confirm procedures for product recalls are established and periodically tested. | – Mock recall exercises – Recall documentation |
| Cleaning and Environmental Controls | Confirm proper cleaning and sanitation procedures are consistently followed. | – Surface cleaning logs – Waste disposal tracking |
Determining Level of Compliance
To assess compliance with the pharmacy’s compounding policies and procedures:
| Compliance Level | Description | Action |
| Full Compliance | All QA verification requirements are met; no major issues identified. | Routine QA monitoring continues. |
| Partial Compliance | Minor deviations that do not compromise patient safety or product quality; corrective actions needed. | Plan and document corrective actions; retrain staff if necessary. |
| Non-Compliance | Major issues identified (e.g., training lapses, missing records, serious process errors). | Immediate corrective actions required; possible temporary suspension of compounding activities; report to regulatory authority if needed. |
Audit Tools to Support Compliance Monitoring:
QA verifications should be supported by formalized, repeatable processes:
- Self-inspection checklists (recommended quarterly or biannually)
- Supervisor observational audits (monthly)
- External audits (periodic, as determined by provincial/territorial authority)
Important Reminders:
- Continuous Quality Improvement (CQI) must be part of the QA program — meaning issues are not just corrected but also used to improve the system.
- Document everything: training records, deviation reports, cleaning logs, maintenance certificates, and risk assessments must be traceable and readily available.
- Review policies every 3 years or immediately when compounding standards, pharmacy services, or regulations change.
See sample template below, based on NAPRA MSOP COMPOUNDING OF NON-STERILE PREPARATIONS guidelines:
Quality Assurance Audit Sample Template
Verifying QA is not a one-time task—it is a continuous cycle of assessment, correction, and improvement. By regularly evaluating training, facilities, process control, risk management, and incident handling, pharmacies demonstrate a commitment to high-quality care. Most importantly, acting on QA findings is where real improvement occurs. Whether it’s updating SOPs, retraining staff, improving equipment maintenance, or adjusting risk protocols, every action taken after a QA verification strengthens the safety net around compounded preparations. Pharmacies that embrace this mindset are better prepared to meet both patient needs and regulatory expectations.
