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

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