19 Chapter 19: Quality Assurance and Safety Measures

In Canada, the National Association of Pharmacy Regulatory Authorities (NAPRA) has established comprehensive model standards and guidance documents 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)

Definition:
Quality Assurance refers to the systematic processes and procedures that ensure compounded preparations meet established standards of quality, safety, and efficacy.

Key QA Elements as per NAPRA:

• Standard Operating Procedures (SOPs): Detailed, written instructions for all aspects of the compounding process — from receipt of raw materials to final product labeling and dispensing.

• Personnel Training and Competency: Documentation of initial and ongoing training. Competency must be assessed and documented regularly.

• Facilities and Equipment Maintenance: Regular cleaning, calibration, and maintenance of all compounding areas and equipment.

• Documentation: Accurate records of formulas, compounding logs, calculations, cleaning, calibration, and verification steps.

• Ongoing Monitoring and Review: Periodic audits and quality checks to detect deviations and implement corrective actions.

QA Best Practices:

• Implement a QA program tailored to the complexity and risk level of the compound.

• Conduct periodic internal audits.

• Maintain a corrective and preventive action (CAPA) process.

• Use a master formulation record (MFR) and compounding record (CR) for every preparation.

2. Quality Control (QC)

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.

• 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:

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

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

3. Safety Measures

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.

• 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, 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