Understanding OPQ Standards for Non-Sterile Compounding
The Ordre des pharmaciens du Québec (OPQ) establishes comprehensive standards for the preparation of non-sterile magistral compounds in Quebec pharmacies. These standards ensure that compounded preparations meet rigorous quality and safety requirements while respecting the professional autonomy of pharmacists in individualizing patient therapy.
Regulatory Framework
OPQ standards for non-sterile compounding are based on:
- USP 795 Pharmaceutical Compounding – Non-Sterile Preparations - the U.S. standard
- Evidence-based pharmacy practice in compounding
- International best practices from compounding organizations
- Patient safety principles and quality standards
The standards apply to all pharmacies in Quebec that prepare non-sterile magistral compounds, including community pharmacies, hospital pharmacies, and specialized compounding facilities.
Key Requirements Overview
Compounding Area Requirements The compounding environment must be:
- Clean and well-organized with appropriate storage
- Separated from retail operations and public areas
- Equipped with adequate lighting, ventilation, and work surfaces
- Maintained at appropriate temperature and humidity levels
- Free from contamination and pest activity
Equipment and Supplies
- All measuring and mixing equipment must be appropriate for pharmaceutical use
- Equipment must be regularly calibrated and maintained
- Graduated cylinders, mortars, and pestles must meet pharmaceutical standards
- Equipment must be clean and properly stored between uses
Ingredient Control
- All ingredients must be pharmaceutical quality or better
- Ingredients must be verified for identity and purity before use
- Expired or suspect ingredients must not be used
- Documentation of ingredient verification must be maintained
Environmental Monitoring Requirements
Temperature and Humidity Control
Non-sterile compounding requires controlled environmental conditions:
Temperature
- Maintained between 15-25°C (59-77°F) for most operations
- Critical for stability of many formulations
- Continuous or frequent monitoring required
- Documentation of all readings essential
Humidity
- Relative humidity maintained between 30-65%
- Excessive humidity can degrade hygroscopic ingredients
- Low humidity can affect flow properties and weight
- Monitoring and documentation provide evidence of appropriate conditions
Monitoring Frequency
The frequency of environmental monitoring should be determined by:
- Risk assessment of the compounding operations
- Nature of formulations prepared (aqueous, oleaginous, semi-solids)
- Stability characteristics of commonly compounded preparations
- Regulatory inspection experience and best practices
ATEK’s continuous monitoring systems provide comprehensive documentation exceeding typical monitoring requirements.
Documentation of Monitoring
Environmental monitoring data must be:
- Recorded with date and time of observation
- Associated with the compounding operations performed
- Reviewed for trends and deviations
- Available for regulatory inspection
- Retained according to regulatory requirements
Beyond-Use Dating (BUD) Assignment
BUD Determination Process
Beyond-use dating is critical for ensuring patient safety. The appropriate BUD is determined by:
Formulation Type
- Aqueous preparations (solutions, suspensions): generally shorter BUD due to potential for microbial growth
- Non-aqueous preparations (oils, ointments): potentially longer BUD due to lower contamination risk
- Semi-solid preparations (creams, gels): BUD depends on water content and antimicrobial preservatives
- Solid preparations (capsules, tablets): generally longer BUD if properly packaged
Ingredients Used
- USP or NF ingredients (known stability profiles)
- Non-standard ingredients (may require stability testing)
- Preservative systems (aqueous preparations require appropriate preservatives)
- Antioxidants and chelating agents (affect stability)
Storage Conditions
- Room temperature storage (15-25°C): most common BUD
- Refrigerated storage (2-8°C): typically supports longer BUD
- Frozen storage (below -20°C): supports extended BUD for appropriate formulations
- Light protection: some formulations require amber packaging for stability
Stability Information
- Published stability data for similar formulations
- Manufacturer recommendations for specific ingredients
- Stability testing performed if necessary
- Risk assessment based on formulation complexity
Documentation Supporting BUD
ATEK helps support appropriate BUD assignments by:
- Documenting exact storage conditions throughout the retention period
- Recording any temperature or humidity excursions
- Providing complete audit trail of environmental parameters
- Generating reports showing conditions met expectations
- Creating evidence suitable for regulatory review
Quality Assurance Program
Visual Inspection
Each compounded preparation must be visually inspected for:
- Appearance: Color, clarity, consistency appropriate for formulation type
- Particulates: Freedom from visible foreign matter
- Separation: No inappropriate layering or phase separation
- Odor: No off-odors suggesting degradation or contamination
- Labeling: Correct ingredients, strength, instructions, and BUD
Weight and Volume Verification
For appropriate preparations:
- Dose consistency checks (for solid forms)
- Volume measurements for liquid preparations
- Weight variation testing for capsules or tablets
- Documentation of acceptance criteria and results
Risk-Based Testing
Depending on formulation complexity:
- pH testing: For aqueous formulations (stability and compatibility)
- Viscosity testing: For suspensions and emulsions
- Sterile filter validation: For preparations requiring terminal sterilization
- Stability testing: For novel formulations or extended BUD claims
- Preservative effectiveness testing: For multi-dose aqueous preparations
Compounding Documentation
Master Formulation Records
Each compound must have a master formulation record including:
- Complete formulation with exact ingredients and quantities
- Step-by-step compounding procedure
- Equipment required
- Expected yield and calculations
- Quality control procedures and acceptance criteria
- Beyond-use date and storage instructions
- Special precautions or warnings
Batch Preparation Records
Each compounded batch must be documented with:
- Date and time of preparation
- Pharmacist name (formulator)
- Pharmacy technician name (if involved)
- Actual quantities of each ingredient used
- Source and lot numbers of ingredients
- Equipment used for compounding
- Results of all quality control testing
- Any deviations or issues encountered
- Final yield and quantity of usable product
Quality Control Documentation
Record all QC testing:
- Test method and date/time performed
- Person performing test
- Results obtained
- Acceptance criteria and pass/fail determination
- Investigation of failures
- Disposition of failed batches
Personnel Training and Competency
Initial Training Requirements
All pharmacy staff involved in compounding must receive training in:
- Compounding fundamentals: Measurements, weights, volumes, dilutions, concentrations
- Pharmaceutical calculations: Percentages, ratios, specific gravity, osmolarity
- Compounding techniques: Mixing, dissolving, suspending, emulsifying, filling
- Quality standards: Visual inspection, testing procedures, documentation
- Regulatory requirements: OPQ standards, record-keeping, BUD assignment
- Safety procedures: Handling pharmaceutical ingredients, equipment operation, spill cleanup
Competency Assessment
Competency must be demonstrated through:
- Practical demonstration: Ability to perform actual compounding tasks
- Direct observation: Supervisor verification of technique and procedures
- Calculation testing: Accuracy in pharmaceutical calculations
- Documentation review: Understanding of record-keeping requirements
- Written examination: Knowledge of OPQ standards and best practices
Ongoing Professional Development
Competency must be maintained through:
- Annual retraining: Review of standards and procedures
- Continuing education: Updates on new formulations or techniques
- Periodic assessment: Verification of continued competency
- Incident review: Learning from any preparation issues or complaints
- Professional literature: Awareness of developments in compounding practices
Equipment Calibration and Maintenance
Calibration Requirements
All measuring and compounding equipment must be:
- Properly calibrated before initial use
- Periodically recalibrated according to manufacturer recommendations
- Verified for accuracy using appropriate standards
- Documented with calibration dates and results
- Traceable to national or international standards where applicable
Maintenance Program
Equipment maintenance must include:
- Regular cleaning appropriate for the equipment type
- Visual inspection for damage or wear
- Functional testing to ensure proper operation
- Preventive maintenance according to manufacturer specifications
- Documentation of all maintenance activities
Maintenance Records
Maintain records including:
- Equipment identification and serial number
- Calibration dates and results
- Maintenance activities performed
- Any repairs or replacement parts
- Operator name and date
- Any issues identified and actions taken
Inspection and Compliance
OPQ Inspection Focus Areas
During inspections, OPQ evaluators assess:
Compounding Area
- Cleanliness and organization
- Appropriate separation from retail areas
- Environmental monitoring data and equipment
- Pest control and sanitation measures
Documentation Systems
- Master formulation records for compounds prepared
- Batch preparation records with complete details
- Quality control test results and documentation
- Equipment calibration and maintenance records
- Personnel training and competency files
Personnel Competency
- Evidence of initial training
- Documentation of competency assessment
- Annual retraining records
- Knowledge of regulatory requirements
Quality Assurance
- Written policies and procedures
- Implementation of visual inspection procedures
- Risk-based testing protocols
- Investigation of any preparation issues
- Trends in quality and incidents
Preparing for Inspection
Maintain organized systems for:
- Current environmental monitoring data (minimum 2 years)
- Master formulation records for all compounds prepared
- Batch preparation records with complete documentation
- Personnel training and competency records
- Equipment calibration and maintenance certificates
- Quality control test results and trends
- Ingredient verification and sourcing documentation
- Beyond-use dating assignments with supporting rationale
How ATEK Supports OPQ Compliance
Comprehensive Environmental Monitoring
ATEK provides continuous monitoring of compounding environment conditions:
- Temperature Monitoring: Real-time tracking with historical data
- Humidity Monitoring: Continuous relative humidity recording
- Data Integration: All parameters in one unified system
- Alert System: Immediate notification of any deviations
- Trend Analysis: Visual representation of environmental performance
Automated Documentation
ATEK automatically generates required documentation:
- Daily Monitoring Reports: Summary of environmental conditions
- Environmental Data Logs: Complete timestamp records of all readings
- Deviation Alerts: Documentation of any out-of-specification events
- Compliance Reports: Summary suitable for regulatory review
- Trend Analysis: Statistical review of environmental performance
Storage Condition Documentation
Support for beyond-use dating determination:
- Continuous Recording: Exact conditions during storage period
- Excursion Detection: Automatic identification of deviations
- Report Generation: Environmental summary for each storage period
- Audit Trail: Complete history suitable for regulatory inspection
Quality Assurance Integration
ATEK supports your quality assurance program:
- Quality Data Management: Centralized storage of environmental and QC data
- Trend Analysis: Identification of patterns in environmental performance
- Document Organization: Systematic storage of all required records
- Report Generation: Compliance documentation for inspections
- Audit Trail: Complete history of all monitoring activities
Best Practices for OPQ Compliance
Establish Written Procedures
Document procedures for:
- Compounding environment maintenance and monitoring
- Ingredient verification and storage
- Compounding techniques for common formulations
- Quality control and testing procedures
- Documentation and record-keeping
- Equipment calibration and maintenance
- Personnel training and competency assessment
- Investigation and corrective action procedures
Implement Environmental Monitoring
- Establish baseline environmental conditions
- Determine appropriate monitoring frequency
- Select appropriate monitoring equipment
- Develop response procedures for deviations
- Review and trend monitoring data regularly
- Document all monitoring activities
Maintain Quality Focus
- Regular review of compounding procedures
- Trend analysis of quality control results
- Investigation of any preparation issues
- Implementation of corrective and preventive actions
- Staff communication about quality expectations
- Recognition of quality achievements
Support Personnel Development
- Provide comprehensive initial training
- Verify competency before independent practice
- Conduct regular retraining and professional development
- Review individual performance through direct observation
- Encourage participation in quality activities
- Maintain complete training documentation
Organize Documentation Systems
- Centralized storage of all records
- Easy retrieval system for audits and inspections
- Electronic backup systems for critical data
- Retention schedule aligned with regulatory requirements
- Version control for procedures and policies
Related Regulations and Standards
Organizations preparing non-sterile compounds in Quebec should also be aware of:
- OPQ Steriles Standards - Separate requirements for sterile compounding
- USP 795 - Pharmaceutical Compounding – Non-Sterile Preparations
- USP 800 - Handling of Hazardous Drugs (for hazardous components)
- ISO 9001 - Quality Management Systems
- Health Canada Guidelines - Pharmaceutical compounding requirements
- Consumer Product Safety Act - For specific compounded preparations