32 Chapter 32: Documentation of Quality Assurance Verification
**May take this chapter out or edit the learning step** very similar to Chapter 29
In non-sterile compounding, quality assurance (QA) documentation serves as both a compliance tool and a safeguard for patient safety. Properly maintained records — including logs, reports, and corrective action documentation — help verify that procedures are followed, standards are met, and risks are addressed. This learning step focuses on identifying the required types of QA documentation, assessing their completeness and accuracy, and using these records to guide continuous quality improvement. Understanding how to critically evaluate QA documentation is essential for maintaining regulatory compliance and ensuring the integrity of compounded products.
- Purpose of QA Documentation
In non-sterile compounding, documenting quality assurance (QA) activities is essential to:
- Demonstrate compliance with NAPRA standards and provincial/territorial regulations.
- Ensure product quality and patient safety.
- Identify trends or weaknesses in the compounding process.
- Enable corrective actions when deviations occur.
- Support accountability and continuous improvement.
- Types of Quality Assurance Documentation
The pharmacy must maintain clear and complete records of all QA activities. These include:
| Type | Purpose | Examples |
| Logs | Ongoing, routine recording of specific tasks | Cleaning logs, equipment maintenance logs, temperature logs |
| Reports | Detailed review of QA checks and verifications | Incident reports, deviation reports, periodic compliance audits |
| Follow-up Documentation | Record of corrective actions taken | Corrective and Preventive Action (CAPA) reports, retraining records, updated procedures |
- Required QA Verifications to Document
According to the standards and guidance, documentation must include results for the following verifications:
- Facility and Equipment Cleaning and Maintenance (cleaning schedules, equipment calibration and repair logs)
- Environmental Controls (e.g., temperature and humidity checks)
- Personnel Training and Skills Assessment (initial and ongoing competency validation records)
- Master Formulation Record and Compounding Record Verifications (ensuring preparations are compounded according to approved formulations)
- Quality Control Checks (e.g., pH testing, weight variations of capsules, visual inspections)
- Incident Management (documentation of errors, deviations, complaints, adverse events)
- Assessment of QA Documentation
When assessing QA documentation, the following must be reviewed:
| Area | Assessment Focus |
| Completeness | Are all required fields filled out? (e.g., dates, initials, observations, corrective actions) |
| Accuracy | Are the records accurate and match the actual activities performed? |
| Timeliness | Are entries made immediately after the activity occurs? |
| Corrective Actions | Are deviations or non-compliance issues clearly recorded and properly addressed? |
| Traceability | Can compounded preparations be traced back to specific equipment, personnel, and raw materials? |
| Retention | Are records stored and retained according to legal and regulatory requirements? (as specified by provincial/territorial authorities) |
- Follow-up Actions Based on QA Documentation
- If a deficiency or deviation is identified:
- Investigate the root cause.
- Document the findings thoroughly.
- Implement corrective and preventive actions (CAPA).
- Update policies, procedures, or training programs if needed.
- Re-train staff as appropriate and document the training.
- Results from incident and deviation reports must be analyzed periodically to identify patterns and proactively prevent future problems.
- Quality Assurance Program Oversight
The pharmacy’s Compounding Supervisor or Pharmacy Manager is responsible for:
- Ensuring all QA verification activities are documented correctly.
- Reviewing QA documentation regularly (e.g., quarterly).
- Reporting major findings to pharmacy leadership and regulatory authorities if necessary.
- Auditing the effectiveness of the QA program based on the documented results.
Effective QA documentation — including accurate logs, reports, and records of corrective actions — is crucial to maintaining the integrity of compounded preparations and achieving full compliance with NAPRA standards. Regular assessment of these documents helps build a strong, safe, and continuously improving compounding practice.
Sample QA Documentation Review Checklist (For Non-Sterile Compounding — Based on NAPRA Standards and Guidance Document) **make this a form
| Area | Question | Yes / No / N/A | Comments / Corrective Actions |
| Facility and Equipment Cleaning | Are cleaning logs complete and up-to-date? | ||
| Are maintenance logs for equipment (e.g., balances, mixers) documented regularly? | |||
| Are environmental control logs (e.g., temperature, humidity) properly recorded? | |||
| Personnel Training and Assessment | Are training records for all compounding staff current and complete? | ||
| Are skills assessments documented for all compounding personnel? | |||
| Are retraining sessions recorded when deficiencies are identified? | |||
| Master Formulation and Compounding Records | Are master formulation records available and reviewed periodically? | ||
| Are compounding records complete for each batch or prescription? | |||
| Is the rationale for compounding commercially available products documented when required? | |||
| Quality Control Verification | Are quality control test results (e.g., weight checks, pH testing) documented for each preparation where applicable? | ||
| Are deviations or incidents related to quality control logged and investigated? | |||
| Incident Reporting and Follow-up | Are incidents, deviations, and adverse events recorded appropriately? | ||
| Are corrective and preventive actions (CAPA) documented and followed up? | |||
| Are CAPA outcomes evaluated for effectiveness? | |||
| Record Management | Are all records securely stored and easily retrievable? | ||
| Are records retained for the period required by the applicable regulatory authority? | |||
| General QA Program Compliance | Is there a scheduled review of QA documentation (e.g., quarterly, annually)? | ||
| Are findings from QA reviews reported to pharmacy management? | |||
| Are updates to procedures made based on QA findings? |
Instructions for Use:
- Review each item periodically (e.g., monthly, quarterly).
- Mark “Yes” if fully compliant, “No” if not compliant, and “N/A” if not applicable.
- Use the Comments / Corrective Actions column to note any deficiencies and describe actions needed.
Retain completed checklists as part of the pharmacy’s QA documentation for future audits or inspections
Thorough and timely documentation of QA activities is fundamental to safe and compliant non-sterile compounding. Logs, reports, and follow-up records provide essential evidence of quality control, staff competency, and adherence to procedures. By routinely assessing these documents for completeness, accuracy, and follow-through on corrective actions, pharmacies can identify gaps early, prevent recurring issues, and continuously strengthen their compounding practices. A robust QA documentation system not only supports regulatory readiness but also builds a culture of accountability and excellence in patient care.
