Independent GMP audits provide an objective assessment of your quality systems, manufacturing operations and regulatory compliance. Our experienced auditors identify critical gaps, assess regulatory risks and recommend practical corrective actions to help organizations achieve inspection readiness and maintain sustainable GMP compliance.
What We Deliver
- GMP Gap Assessment — Comprehensive evaluation of facilities, documentation and quality systems against WHO-GMP, revised Schedule M and international GMP standards.
- Mock Regulatory Inspection — Simulation of regulatory inspections to assess inspection readiness and identify compliance deficiencies before official audits.
- Data Integrity Audit — Evaluation of computerized systems, documentation practices and compliance with ALCOA+ principles.
- Facility & Engineering Audit — Assessment of HVAC systems, water systems, cleanrooms, utilities and engineering controls.
- Quality Management System Audit — Independent review of deviations, CAPA, change control, risk management, training and document control systems.
- Follow-up Audit & CAPA Verification — Verification of corrective and preventive action implementation and effectiveness.
Our Approach
Audit Planning
Define audit scope, objectives, applicable GMP standards and audit schedule.
On-site Assessment
Conduct independent audits of facilities, documentation, quality systems and manufacturing operations through interviews, document reviews and facility walkthroughs.
Audit Report & CAPA
Prepare a detailed audit report with risk categorization, observations, root causes and practical CAPA recommendations.
Follow-up & Compliance Verification
Review CAPA implementation, verify effectiveness and support continuous GMP improvement.
Who this is for
Why Choose Vaayath
- 20+ years of pharmaceutical regulatory experience
- Independent third-party audit approach
- Experience across formulation, API and sterile facilities
- Practical CAPA recommendations
- Expertise in WHO-GMP, revised Schedule M and international GMP standards
- Confidential and objective assessments