29 Chapter 29: Quality Assurance Verification
Ensuring the quality, safety, and consistency of non-sterile compounded preparations is a cornerstone of pharmacy practice. To achieve this, pharmacies must implement a robust Quality Assurance (QA) program in alignment with the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations and its accompanying Guidance Document. QA verifications are structured, documented activities that assess compliance with established compounding policies, procedures, and regulatory expectations. This learning step 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 (Based on NAPRA Standards and Guidance Document)
| 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
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| 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
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| 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:
- 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.
Quality Assurance (QA) Audit Checklist for Non-Sterile Compounding:
(Based on NAPRA Standards and Guidance Document)
Pharmacy Name: _______________________
Date of Audit: _________________________
Auditor(s): ____________________________
Section 1: Personnel Training and Competency
| Item | Verification | Findings | Corrective Action (if needed) |
| Initial training completed for all compounding staff | Yes / No | ||
| Annual competency assessments completed | Yes / No | ||
| Staff training updated after SOP revisions | Yes / No | ||
| Training records available and complete | Yes / No |
Section 2: Facilities and Equipment Maintenance
| Item | Verification | Findings | Corrective Action (if needed) |
| Compounding area designated and maintained | Yes / No | ||
| Cleaning logs up to date | Yes / No | ||
| Equipment properly maintained and calibrated | Yes / No | ||
| Environmental controls (ventilation, temperature) adequate | Yes / No |
Section 3: Compounding Process and Product Quality Control
| Item | Verification | Findings | Corrective Action (if needed) |
| Compounding Records completed for each preparation | Yes / No | ||
| Master Formulation Records available and accurate | Yes / No | ||
| Labeling meets standards (active ingredients, BUD, storage) | Yes / No | ||
| Physical inspection (e.g., uniformity, absence of contamination) completed | Yes / No | ||
| Specific QC tests performed as applicable (e.g., pH, weight checks) | Yes / No |
Section 4: Risk Assessment and PPE
| Item | Verification | Findings | Corrective Action (if needed) |
| Risk assessments documented for each preparation | Yes / No | ||
| PPE used appropriately according to risk level | Yes / No | ||
| PPE training records available | Yes / No |
Section 5: Incident Reporting and Policy Compliance
| Item | Verification | Findings | Corrective Action (if needed) |
| Incident and deviation logs maintained | Yes / No | ||
| Corrective actions documented and completed | Yes / No | ||
| Policies and procedures reviewed within last 3 years | Yes / No | ||
| Staff acknowledgment of policies documented | Yes / No |
Section 6: Recall Procedures
| Item | Verification | Findings | Corrective Action (if needed) |
| Recall procedure established and documented | Yes / No | ||
| Recall drills or mock exercises completed | Yes / No |
Summary of Audit
| Area | Overall Compliance (Circle) | Notes |
| Personnel Training | Compliant / Partially Compliant / Non-Compliant | |
| Facility & Equipment | Compliant / Partially Compliant / Non-Compliant | |
| Process & Product Quality | Compliant / Partially Compliant / Non-Compliant | |
| Risk Management & PPE | Compliant / Partially Compliant / Non-Compliant | |
| Incident Reporting & Policies | Compliant / Partially Compliant / Non-Compliant | |
| Recall Procedures | Compliant / Partially Compliant / Non-Compliant |
Overall Audit Result: __________________________
Follow-up Date (if needed): _____________________
Signature of Auditor(s): ________________________
End of QA Audit Checklist
QA verifications encompass personnel training, facility and equipment maintenance, compounding process control, quality checks, and incident reporting. Compliance can be classified as full, partial, or non-compliant, with each level requiring different corrective actions. The use of structured audit tools, clear documentation, and ongoing review of policies supports a culture of quality and safety. By integrating QA verifications into routine pharmacy practice, pharmacies help ensure compounded preparations meet the highest standards of patient care and regulatory compliance.
