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1. 1. Compound Information: Basic details about the compound including name, form, strength, and intended use
2. 2. Personnel and Facilities: Assessment of staff competency, facility requirements, and available equipment
3. 3. Risk Classification: Determination of compound risk level (low, medium, high) based on complexity, ingredients, and processing
4. 4. Ingredient Assessment: Evaluation of all ingredients including active substances, excipients, and their associated risks
5. 5. Process Assessment: Analysis of each step in the compounding process and associated risks
6. 6. Quality Control Requirements: Specific quality control measures required for the compound
7. 7. Stability Assessment: Evaluation of compound stability and assignment of beyond-use date
8. 8. Documentation Requirements: Required records, logs, and monitoring documentation
9. 9. Risk Control Measures: Specific controls to mitigate identified risks
10. 10. Emergency Procedures: Response procedures for potential incidents or accidents
1. Sterile Compounding Requirements: Additional requirements for sterile preparations, including environmental monitoring and aseptic technique validation
2. Hazardous Drug Handling: Special precautions and requirements when compounding hazardous drugs
3. Pediatric/Special Population Considerations: Additional risk factors when compounding for vulnerable populations
4. Environmental Impact Assessment: Evaluation of environmental risks and waste management requirements
5. Cross-Contamination Prevention: Additional controls needed when compounding multiple products
6. Alternative Methods Assessment: Evaluation of alternative compounding methods or commercially available products
1. Schedule A: Risk Assessment Matrices: Standardized matrices for evaluating different risk factors
2. Schedule B: Equipment Validation Requirements: Detailed requirements for equipment validation and maintenance
3. Schedule C: Personal Protective Equipment Guidelines: Specific PPE requirements based on risk levels
4. Schedule D: Cleaning and Sanitization Procedures: Detailed cleaning protocols and requirements
5. Schedule E: Quality Control Testing Specifications: Detailed testing requirements and acceptance criteria
6. Appendix 1: Risk Assessment Forms: Standard forms for documenting risk assessments
7. Appendix 2: Reference Standards: Relevant professional standards and guidelines
8. Appendix 3: Emergency Contact Information: List of emergency contacts and procedures
9. Appendix 4: Training Requirements: Required training and competency assessments for staff
Beyond-Use Date (BUD)
Compounding
Complex Compounding
Critical Process Parameters
Cross-Contamination
Environmental Monitoring
Excipient
Facility Grade
Hazardous Drug
High-Risk Compounding
Master Formulation Record
Non-Sterile Compounding
Personal Protective Equipment (PPE)
Pharmaceutical Grade
Primary Engineering Control
Quality Control
Raw Material
Risk Assessment
Risk Control Measure
Risk Level
Secondary Engineering Control
Simple Compounding
Stability
Sterile Compounding
Standard Operating Procedure (SOP)
Therapeutic Goods
United States Pharmacopeia (USP)
Validation
Verification
Facility Requirements
Personnel Qualifications
Equipment Specifications
Quality Control
Documentation Requirements
Health and Safety
Environmental Controls
Process Validation
Material Handling
Emergency Procedures
Contamination Control
Training Requirements
Record Keeping
Cleaning and Sanitization
Waste Management
Product Testing
Stability Assessment
Regulatory Compliance
Standard Operating Procedures
Risk Mitigation
Quality Assurance
Incident Reporting
Change Control
Audit Requirements
Healthcare
Pharmaceutical
Hospital Services
Community Pharmacy
Veterinary Medicine
Clinical Research
Medical Manufacturing
Pharmacy Operations
Quality Assurance
Regulatory Compliance
Clinical Services
Manufacturing
Health and Safety
Risk Management
Training and Development
Documentation Control
Sterile Services
Pharmacist
Pharmacy Technician
Quality Assurance Manager
Compliance Officer
Hospital Pharmacy Manager
Clinical Pharmacist
Compounding Specialist
Pharmaceutical Manufacturing Manager
Regulatory Affairs Specialist
Health and Safety Officer
Pharmacy Operations Manager
Sterile Services Manager
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