Organizations are moving towards procedural standardization, risk-based methodology, quality by design (QbD) and common control framework.
Our experts perform specialized GxP audits, QMS Remediation, Process and Product Validation and GxP Solution consulting services to assist Life Sciences organizations comply with Health Authority requirements.
Audit services
- GxP assessment and process establishment
- Performing audit for established GxP set ups
- Inspection readiness
- Good Manufacturing Practice - GMP audits
- cGMP audits
- GMP compliance assessment
- GxP risk assessment
- Good Laboratory Practice - GLP audit
- Good Storage and Good Distribution Practices - GSP / GDP
- Audit trail adequacy assessment
- Response to Regulatory audit report
- Audit report preparation/submission
- Performing RCA (Root Cause Analysis) and CAPA (Corrective Action /Preventive Action) for a Regulatory audit
- Due diligence audit
Quality Managment System
We can create or adapt a QMS that will keep you compliant, meet your objectives, and reduce your risks, through:
- Determination the type of SOP needed
- Drafting and managing SOPs
- Reviewing SOPs
- Training internal systems on new SOPs
- Periodic GxP Compliance Audit with audit report and recommendations
- Preparation of audit metrics to the management