Competencies: GCP, GDP, Audits, Pharmacy, Regulatory Science, Clinical Trial Quality, Clinical Research and Regulations, Project Management, Clinical Trials, Regulatory and Quality Sciences, Clinical Trial Workforce
Course Syllabus/Topics:
- Objectives
- General overview supply chain management
- Challenges
- GDP and GMP
- “Amazon” effect; transformed how we think about supply chain, extended to clinical trials
- Definition of supply chain management
- Pharmaceutical supply chain
- Distribution in a nutshell
- Drug product distribution
- Right patient, blinding of information
- Traceability of information, reverse logistics pathway for recalls
- Clinical supply chain management
- Good distribution practices (GDP)
- Key pillars: medicines in the supply chain are authorized in accordance with legislation, prevent cross-contamination, ensure proper delivery
- International GDP standards and variations
- Labeling, packaging, distribution guidelines may differ
- GDP Pillars
- Quality management
- Personnel
- Internal audits
- Vendor qualification program
- Differences between GDP and GMP
- Responsibilities, personnel, security level, validation, temperature controls, broker supervision
- Conflict of interest
- Quality management system
- Quality policy, manual, appointed responsible person, third party distributor and their system
- Quality system need to be compliant with GDPs
- Risk management/ Product traceability
- Risk-based approach
- Organizational chart and personnel
- Note: Training for transport personnel on clinical trial protocol among others
- Premises
- Preventative Maintenance
- Equipment list, temperature mapping, run studies to ensure temperature controls
- Ensure proper repairs, calibration intervals and records are maintained
- Validation and qualification
- Process controls
- Packaging and labeling
- Languages, declarations in different languages
- Documentation- Good Documentation Practices (GDocP)
- Computer systems
- Backups for documentation
- Record retention policies and practices
- Archived hard copies
- Verification and validation
- Self-inspections
- Internal audit schedule
- Corrective actions documentation
- Third party provider may ask for audits
- Control of quality management system
- Complaints and recalls
- Recall procedures
- documentation of destruction
- Supplier qualification
- Broker provisions
- Group exercise
- Questions
- Raffle prize winner announcement
Acknowledgements:
Accompanying text created by: Roxy Terteryan, Project Administrator, SC CTSI
Rushaanaaz Sokeechand, Student Worker; Mahita Parasa, Student Worker