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1. 1. Introduction: Overview of the assessment scope, facility details, and purpose of the risk assessment
2. 2. Compounding Activities Overview: Detailed description of types of compounding performed, volume, and complexity of operations
3. 3. Regulatory Framework: Summary of applicable regulations and standards governing the compounding activities
4. 4. Risk Assessment Methodology: Description of the risk assessment approach, scoring systems, and evaluation criteria used
5. 5. Hazard Identification: Comprehensive list of potential hazards associated with compounding activities, including chemical, biological, and physical hazards
6. 6. Risk Analysis: Detailed analysis of identified risks, including likelihood and severity assessments
7. 7. Control Measures: Description of existing and proposed control measures to mitigate identified risks
8. 8. Monitoring and Review: Procedures for ongoing monitoring of risks and periodic review of assessment
9. 9. Training Requirements: Specific training needs identified based on risk assessment results
10. 10. Emergency Procedures: Procedures for handling accidents, spills, and other emergencies related to compounding activities
1. Sterile Compounding Specific Risks: Include when facility performs sterile compounding, detailing additional controls and monitoring required
2. Hazardous Drug Handling: Include when facility compounds hazardous drugs, addressing specific safety measures and containment strategies
3. Pediatric Compounding Considerations: Include when facility compounds medications for pediatric patients, addressing specific risk factors
4. Automated Compounding Equipment: Include when facility uses automated compounding devices, addressing associated risks and controls
5. Environmental Monitoring Program: Include for facilities requiring specific environmental controls and monitoring
6. Cross-Contamination Prevention: Include when facility compounds multiple products or handles allergenic materials
1. Appendix A: Risk Assessment Matrices: Templates and scoring guides for risk evaluation
2. Appendix B: Hazard Registry: Detailed listing of all identified hazards and their characteristics
3. Appendix C: Control Measure Checklist: Comprehensive checklist of required control measures and verification steps
4. Appendix D: Monitoring Forms: Templates for ongoing monitoring and documentation
5. Appendix E: Training Records Template: Format for documenting staff training and competency assessment
6. Appendix F: Incident Report Forms: Templates for reporting and investigating incidents or near-misses
7. Schedule 1: Equipment Inventory: List of all compounding equipment and associated risk factors
8. Schedule 2: Material Safety Data Sheets: Collection of relevant MSDS for compounds and chemicals used
9. Schedule 3: Regulatory Compliance Checklist: Checklist ensuring compliance with all applicable regulations
Beyond-Use Date (BUD)
Biological Safety Cabinet (BSC)
Compounded Preparation
Compounding Personnel
Containment Primary Engineering Control (C-PEC)
Control Measures
Critical Area
Cross-Contamination
Environmental Monitoring
Hazard
Hazardous Drug
Likelihood
Master Formulation Record
Non-sterile Compounding
Personal Protective Equipment (PPE)
Quality Assurance
Quality Control
Risk Assessment
Risk Level
Risk Mitigation
Secondary Engineering Control (SEC)
Severity
Standard Operating Procedure (SOP)
Sterile Compounding
Unidirectional Airflow
USP Standards
Validation
Verification
Regulatory Compliance
Risk Identification
Risk Analysis
Risk Mitigation
Quality Control
Personnel Safety
Environmental Controls
Emergency Procedures
Documentation Requirements
Training and Competency
Equipment and Facilities
Material Handling
Monitoring and Review
Incident Reporting
Record Keeping
Audit Requirements
Continuous Improvement
Change Management
Responsibilities and Authorities
Healthcare
Pharmaceutical
Hospital Administration
Regulatory Compliance
Quality Assurance
Occupational Health and Safety
Pharmacy Services
Medical Clinics
Long-term Care Facilities
Pharmacy Operations
Quality Assurance
Regulatory Compliance
Risk Management
Health and Safety
Clinical Services
Facilities Management
Environmental Services
Training and Development
Pharmacy Manager
Clinical Pharmacist
Compounding Pharmacist
Quality Assurance Manager
Occupational Health and Safety Officer
Regulatory Compliance Officer
Pharmacy Technician
Environmental Health Officer
Risk Management Specialist
Healthcare Facility Administrator
Chief Pharmacy Officer
Sterile Compounding Supervisor
Quality Control Specialist
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