19 Quality Assurance and Safety Measures

In Canada, the National Association of Pharmacy Regulatory Authorities (NAPRA) has established comprehensive standards to ensure that pharmacists and pharmacy technicians consistently produce safe, effective, and high-quality compounded products. These standards are designed to protect both patients—by minimizing risks of contamination and error—and pharmacy personnel—by reducing occupational exposure to hazardous substances. Quality assurance (QA) and quality control (QC) are the foundation of safe compounding practice. QA refers to the systems and processes that ensure every compounded product meets established standards, while QC focuses on the operational techniques and activities used to verify the quality of each preparation.

Each pharmacy’s QA program will differ based on the applicable compounding requirements (Levels A, B, or C – refer to NAPRA section 8), as well as the type of facilities and equipment in use, the personnel involved, and the scope of compounding activities. Every verification performed under the QA program must be documented.

The NAPRA Model Standards outline a framework for QA, QC and safety in pharmacy compounding practices.

1. Quality Assurance (QA)

QA is a systematic framework designed to ensure that every compounded preparation meets predefined standards for safety, efficacy, and quality. It involves proactive measures to prevent errors, contamination, and deviations, ultimately safeguarding patient health and maintaining trust in pharmacy practice.

Key QA Elements

Standard Operating Procedures (SOPs)

• Purpose: Standardize workflows to minimize variability and errors.
• Examples of SOPs:
  • Cleaning and disinfecting compounding areas.
  • Handling hazardous drugs (e.g., double-gloving, closed-system transfers).
  • Equipment use (e.g., balances, mortars).
  • Labeling and verifying beyond-use dates (BUDs).
• NAPRA Requirement: SOPs must be written, accessible, and reviewed annually.

Personnel Training and Competency

• Initial Training: Covers compounding techniques, math skills, SOPs, and safety protocols.
• Ongoing Education: Annual refreshers on new guidelines (e.g., USP <795> updates).
• Competency Assessments:
  • Practical exams (e.g., correctly preparing a suspension).
  • Written tests on calculations and SOPs.
  • Documented sign-offs by supervising pharmacists.

Facilities and Equipment Maintenance

• Facility Requirements:
  • Dedicated compounding area separated from dispensing.
  • Surfaces that are non-porous, easy to clean, and resistant to chemical damage.
• Equipment Maintenance:
  • Balances calibrated quarterly.
  • Laminar airflow hoods certified every 6 months.
  • Cleaning logs for mortars, spatulas, and other tools.

Documentation

• Master Formulation Record (MFR):
  • Includes ingredients, quantities, step-by-step instructions, BUD criteria, and references.
  • Must be approved by a pharmacist and reviewed annually.
• Compounding Record (CR):
  • Tracks each batch/prescription, including lot numbers, calculations, and personnel signatures.
• Supporting Logs:
  • Cleaning schedules or logs and types of cleaning agents used (rotate use of agents used if possible).
  • Temperature/humidity monitoring (if applicable).
  • Incident reports and corrective actions.

Ongoing Monitoring and Review

• Internal Audits: Quarterly checks of compounding records, SOP compliance, and facility conditions.
• Corrective and Preventive Actions (CAPA):
  • Root cause analysis for deviations (e.g., incorrect BUD assignment).
  • Implement changes to prevent recurrence (e.g., retraining staff).

QA Best Practices

Risk-Based Approach

• Assign risk levels (A, B, or C) to compounds based on complexity and hazard potential.
  • Example: Level C (high risk) for hazardous drug compounding requires additional QA checks.

Stability and BUD Management

• Use peer-reviewed stability data (e.g., International Journal of Pharmaceutical Compounding) to assign BUDs.
• Default to NAPRA’s BUD guidelines if no data exists (e.g., 30 days for water-based topicals).

Labelling Compliance

• Ensure labels include:
  • Patient name.
  • Drug name, strength, and dosage form.
  • BUD and storage instructions.
  • Auxiliary labels (e.g., “Shake Well,” “For External Use Only”).

Culture of Quality

• Encourage staff to report near-misses and errors without fear of reprisal.
• Hold monthly QA meetings to review incidents and improvements.

Why QA Matters:

• Patient Safety: Reduces medication errors and contamination risks.
• Regulatory Compliance: Meets NAPRA, provincial regulatory bodies, and Health Canada expectations.
• Professional Accountability: Demonstrates the pharmacy’s commitment to quality care.

By integrating these QA principles, pharmacies ensure that every compounded preparation is reliable, traceable, and safe for patient use.

2. Quality Control (QC)

Quality Assurance (QA) establishes the systems and procedures to ensure consistency and safety in compounding, while Quality Control (QC) verifies that each individual preparation meets those established standards through inspection and testing.  Both are very important in pharmacy compounding.  We do go over final check in future chapters, but it is important to understand how the two are related.

Definition:
QC involves the testing, inspection, and verification of compounded products to confirm they meet predefined criteria for identity, strength, quality, and purity.

Key QC Measures:

• Verification of Ingredients:
  • Ensure all raw materials are sourced from qualified suppliers and meet appropriate quality standards (e.g., purity, standard, grade).
• Label and Container Check:
  • Verify correct labels and containers are used, including auxiliary labels (e.g., “Refrigerate,” “Shake Well”).
• Organoleptic Checks:
  • Evaluate appearance, color, odor, texture, and consistency.
• Weight and Volume Checks:
  • Confirm final quantity is within acceptable limits.
• pH Testing:
  • When applicable, confirm product pH is within the intended range.
• Final Product Review: Ensure compound conforms to the Master Formulation Record and Compounding Record.

Retesting and Recalls:

Pharmacies must:

• Establish a documented procedure for product recall in case of patient safety concerns.

• Retain samples (if required by policy or law) for possible testing.

3. Safety Measures

Safety is a fundamental component of compounding practice, not only to protect patients but also to ensure the health and well-being of pharmacy personnel.

Workplace Safety

• Risk Assessments:
  • Prior to compounding, assess the risk associated with the preparation based on the ingredients, process, and dosage form.
• Protective Equipment:
  • Use PPE (gloves, lab coats, goggles, masks) based on risk and regulatory requirements.
  • May require use of dedicated lab coats and washing them regularly.
• Ventilation and Engineering Controls:
  • Employ fume hoods or containment ventilated enclosures (CVEs) for compounds involving hazardous materials or powders.
• Safe Handling of Ingredients:
  • Implement policies for storage, handling, and disposal of hazardous or toxic ingredients (e.g., APIs, hormones, irritants).

Cross-Contamination Prevention

• Dedicated Equipment and Workspaces:
  • Use designated areas and tools for specific compounds to avoid contamination.
• Cleaning Protocols:
  • Clean all equipment and surfaces before and after each compound. Use validated cleaning agents.
• Environmental Monitoring:
  • Especially important for moderate- to high-risk preparations.

Personnel Safety

• Training on Hazardous Materials: Ensure staff are trained to recognize and handle cytotoxic, teratogenic, or sensitizing compounds.
• Incident Reporting: Encourage immediate reporting of spills, exposures, or procedural deviations.

4. Documentation and Traceability

NAPRA requires complete traceability for every compounded preparation ensuring accountability, transparency, and quality, including:

• Name and lot numbers of all ingredients
• Date and initials of personnel involved in preparation and verification
• Storage and beyond-use date (BUD)
• Copies of MFR and CR
• Labeling, packaging, and dispensing records

Effective compounding requires more than just precise formulations—it demands a structured and rigorous approach to quality and safety. By adhering to NAPRA’s model standards for Quality Assurance, Quality Control, and safety protocols, pharmacy professionals can minimize risk, ensure therapeutic efficacy, and protect both patients and personnel.

A well-designed QA program, supported by reliable QC procedures and comprehensive documentation, is vital to ensuring consistency and traceability in pharmacy practice. Equally important are proactive safety practices, including risk assessments, PPE usage, and contamination prevention strategies. When implemented together, these measures form a solid framework that supports excellence in non-sterile compounding and upholds public trust in pharmacy services.