Understanding OPQ Standards for Sterile Compounding
The Ordre des pharmaciens du Québec (OPQ) establishes comprehensive standards for the preparation of non-hazardous sterile compounds in Quebec. These standards ensure that pharmacies preparing sterile compounds maintain the same rigorous quality and safety standards as commercial pharmaceutical manufacturers.
Regulatory Framework
OPQ standards for sterile compounding are based on scientific principles and international best practices, including:
- USP 797 Pharmaceutical Compounding – Sterile Preparations - the U.S. standard
- ISO 14644 - cleanroom classification standards
- ISO 20387 - capacity and capability standards
- Evidence-based practices from pharmacy compounding literature
The standards apply to all pharmacies in Quebec that prepare non-hazardous sterile compounds for patients, whether in hospital, community, or specialized compounding settings.
Key Requirements Overview
Facility and Environmental Controls All non-hazardous sterile preparation activities must take place in ISO Class 5 or ISO Class 7 controlled environments:
- ISO Class 5: fewer than 3,520 particles ≥0.5 μm per cubic foot (for direct compounding operations)
- ISO Class 7: fewer than 352,000 particles ≥0.5 μm per cubic foot (for support areas)
Laminar Airflow Equipment Sterile preparation must occur in properly qualified laminar airflow hoods:
- Horizontal or vertical laminar airflow hoods
- Proper air velocity and direction validation
- Regular certification and recertification
Personnel Requirements
- Initial training in aseptic technique and compounding procedures
- Competency assessment with media fill testing
- Periodic retraining and revalidation
- Ongoing professional development
Environmental Monitoring Requirements
Continuous Monitoring
OPQ standards require an established environmental monitoring program with:
Temperature Control
- Controlled room temperature at 20°C or below
- Continuous or frequent monitoring
- Documentation of all readings
- Alerts for deviations
Humidity Control
- Relative humidity below 60%
- Continuous monitoring in critical areas
- Correlation with temperature to ensure proper environment
- Note: Minimum 30% RH is recommended for comfort and to minimize static electricity
Differential Pressure
- Positive or negative pressure as appropriate
- Verification during compounding operations
- Documentation of pressure status
Particulate Monitoring
- Viable (microbial) sampling at established intervals
- Non-viable (particulate) sampling per ISO 14644
- Trend analysis and investigation of deviations
Documentation Requirements
The environmental monitoring program must include:
- Written procedures for all monitoring activities
- Frequency of monitoring based on risk assessment
- Action levels and investigation triggers
- Corrective and preventive action procedures
- Records retention and retrieval procedures
Aseptic Technique and Competency
Initial Competency Assessment
All personnel performing sterile compounding must demonstrate competency through:
Media Fill Testing
- Simulated compounding using culture medium
- Incubation and observation for contamination
- Zero defects required for initial validation
- Performed under actual compounding conditions
Direct Observation
- Observation of compounding techniques
- Assessment by trained supervisor
- Documentation of satisfactory performance
Ongoing Validation
Competency must be revalidated:
- Annually for all personnel
- After extended absences from compounding
- After any procedural changes
- When performance issues are identified
Beyond-Use Dating
BUD Assignment Principles
Beyond-use dates are assigned based on:
Formulation Type
- Aqueous formulations: shorter BUDs due to higher contamination risk
- Oil-based formulations: potentially longer BUDs
- Complex formulations: assessed case-by-case
Storage Conditions
- Refrigerated (2-8°C): supports longer BUDs
- Controlled room temperature (15-25°C): moderate BUDs
- Frozen (-20°C or colder): supports extended BUDs
Risk Level Assessment
- Medium-risk formulations: prepared from USP standard ingredients
- Low-risk formulations: limited ingredient complexity
- Risk assessment documented for each preparation
Storage Condition Documentation
ATEK’s continuous environmental monitoring provides the documented evidence needed to support BUD assignments by recording:
- Exact storage conditions throughout the preparation and storage period
- Any temperature excursions or deviations
- Complete audit trail of environmental conditions
- Data suitable for regulatory review
Quality Control Requirements
Physical and Chemical Testing
Quality control procedures must include:
- Visual inspection: appearance, color, clarity, particulates
- Sterility testing: validation of sterilization methods or aseptic technique
- Potency testing: when appropriate for the formulation
- pH testing: for aqueous formulations
- Stability testing: to support BUD assignments
Documentation
All quality control results must be documented including:
- Test method and acceptance criteria
- Date and time of testing
- Results and any deviations
- Personnel performing the test
- Investigation of any failures
Inspection and Compliance
OPQ Inspection Focus Areas
During inspections, OPQ evaluators assess:
Environmental Controls
- Cleanroom classification verification
- Monitoring equipment qualification
- Environmental monitoring data and trends
- Corrective action documentation
Personnel Competency
- Evidence of training and retraining
- Media fill test results
- Direct observation documentation
- Competency revalidation records
Documentation Systems
- Master formulation records
- Batch preparation records
- Quality control test results
- Equipment maintenance and qualification records
Quality Assurance Program
- Written procedures and policies
- Incident investigation and trending
- Corrective and preventive actions
- Quality metrics and targets
Preparing for Inspection
Organizations should maintain organized documentation including:
- Current environmental monitoring data (minimum 2 years)
- Personnel training and competency records
- Equipment qualification and calibration certificates
- Master formulation records for all compounds prepared
- Quality control test results and trends
- Incident investigation reports
How ATEK Supports OPQ Compliance
Comprehensive Environmental Monitoring
ATEK provides continuous monitoring of all environmental parameters required by OPQ:
- Multi-Parameter Monitoring: Temperature, humidity, differential pressure in one integrated system
- Real-Time Alerts: Immediate notification of any deviations from acceptable ranges
- Continuous Data Logging: Every measurement recorded with timestamp for complete audit trail
- Trend Analysis: Historical data visualization to identify patterns and potential issues
Automated Documentation
ATEK automatically generates the comprehensive documentation required:
- Environmental Monitoring Reports: Daily, weekly, and monthly summaries
- Equipment Status Logs: Laminar airflow hood and monitoring system status
- Excursion Reports: Detailed documentation of any deviations with investigation templates
- Compliance Dashboards: Overview of compliance status across all monitoring points
Quality Assurance Integration
ATEK provides tools for quality assurance programs:
- Quality Data Management: Centralized storage of environmental and quality control data
- Trend Analysis: Statistical analysis of environmental performance and quality metrics
- Document Management: Digital storage and retrieval of all required records
- Audit Trail: Complete history of all system activities for regulatory review
Support for Media Fill Studies
When conducting media fill testing to validate aseptic technique:
- Environmental Documentation: Record environmental conditions during media fill procedures
- Correlation Analysis: Link environmental data to media fill results
- Validation Reports: Generate reports supporting the conclusion that aseptic technique is effective
Best Practices for OPQ Compliance
Establish Written Procedures
Document procedures for:
- Environmental monitoring protocols and frequencies
- Personnel training and competency assessment
- Aseptic technique validation
- Quality control testing
- Investigation and corrective action procedures
- Record retention and retrieval
Implement Preventive Measures
- Regular equipment maintenance and qualification
- Continuous staff training and competency monitoring
- Environmental monitoring data review and trending
- Proactive investigation of near-misses
- Regular mock inspections and gap assessments
Maintain Organized Documentation
- Centralized system for all compliance records
- Regular backup and archival procedures
- Easy retrieval system for inspector requests
- Version control for procedures and policies
Foster Quality Culture
- Commitment from leadership to compliance
- Staff understanding of regulatory requirements
- Clear communication of expectations
- Recognition and reward for compliance excellence
- Regular communication about audit results and improvements
Related Regulations and Standards
Organizations preparing sterile compounds in Quebec should also be aware of:
- USP 800 - Handling of Hazardous Drugs (for any hazardous components)
- USP 795 - Pharmacy Compounding – Non-Sterile Preparations
- ISO 14644-1 - Classification of air cleanliness
- Health Canada Guidelines - Pharmaceutical compounding requirements
- Provincial Health Authority Requirements - Specific requirements for hospital pharmacy networks