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
- Regulatory support and CE marking
- Quality System implementation ISO 13485
- Risk Analysis for the Technical File ISO 14971
- Process Validation
