Good Tissues Practices (GTP)
Good Tissue Practices – Audits for Regulatory Agency Response Formulation & Remediation
GTP Audits:
- GTP – tissue engineering, cell therapy and tissue bank internal audit system development:
- Evaluation of Sponsor and Contract Clinical Supply Operations
- QA/QC system evaluations
- Product investigations
- Labeling
- Storage and distribution
- Regulatory agency audit response formulation and remediation: (PMA, PAI, 483, consent decree, recalls, warning letters and market withdrawals, etc.)
- Quality systems assessment, risk, assessment, design and implementation; Needs/Gap analysis
- Process and scale-up validation
- Equipment qualification/validation
- Computer validation
- Facility design
- Environmental monitoring
- Utility and facility design and monitoring
- Management strategies for compliance systems
- Training of employees to GTP’s; Beginner, Intermediate, Advanced levels; Group or individual
- Vendor and supplier audits – GTP vendor qualification
- Documentation and batch record systems development
- Review and development of SOP’s
- 21 CFR Part 11 compliance
- CAPA/ Deviation systems development
- Stability Program implementation
- Mock FDA/EMA/MHRA auditing
- Recall, Adverse Event and Complaint systems implementation
