GxP & MEDICAL DEVICES

GxP Compliance and Third Party Audits

  • Implementation of Pharmaceutical Quality Systems ICH Q10 and GMP requirements updating.
  • GDPs implementation. Quality Manual and procedures.
  • GMP/GDP/GLP audits: Auditors with international experience. Manufacturing and control of DP, API, excipients, medical devices and food supplements. Development: CROs, bioanalysis, CMC.
  • Risk analysis: Customised training and expert facilitators to lead risk analysis projects: development, validations, process etc.

Data Integrity

  • Gap Analysis and Remediation Plan
  • Data Integrity Policy and Procedures
    • Methodology:
    • Evaluation of the data integrity compliance status of each equipment / system defined in the scope.
    • Preparation of the DI compliance evaluation matrix for each of the systems and classification of deviations according to risk.
    • Drafting of the gap analysis report including proposal of mitigation measures.

FDA projects

  • GAP Analysis and report with recommendations to adapt operations to FDA requirements.
  • Review of CMC documentation to fulfill Question Based Review in generic products. Adaptation to ICH Q8 / Q11 Guidances.
  • Review of Quality System and Quality Control operations and procedures.

Medical Devices

  • Quality System implementation ISO 13485
  • Risk Analysis for the Technical File ISO 14971
  • Process Validation