In a highly regulated life sciences environment, GMP and GxP audits are critical to ensuring product quality, patient safety, and regulatory compliance. Our GMP/GxP Audit services are designed to help pharmaceutical manufacturers, API and intermediate producers, medical device companies, and contract organizations achieve and sustain full compliance with global regulatory requirements.
We conduct independent, risk-based, and regulator-aligned audits that identify compliance gaps, strengthen quality systems, and prepare your organization for successful regulatory inspections.
Comprehensive GMP & GxP Audit Solutions
Our audits are conducted by experienced professionals with deep knowledge of Good Manufacturing Practices (GMP) and Good Practice (GxP) regulations. We focus on both documentation and on-floor practices, ensuring real compliance—not just audit-ready paperwork.
Scope of GMP / GxP Audits
- Internal GMP & GxP Audits
- Quality Management System (QMS) audits
- SOP, documentation, and record control review
- Batch Manufacturing Records (BMR/BPR) verification
- Deviation, CAPA, and change management audits
- Vendor & Supplier Audits
- API and excipient supplier audits
- Contract manufacturing organization (CMO) audits
- Third-party laboratory and service provider audits
- Regulatory & Pre-Inspection Audits
- Pre-CDSCO inspection audits
- US FDA readiness audits
- WHO-GMP and EU GMP gap assessments
- Mock audits simulating real regulatory inspections
- System-Specific Audits
- Data Integrity audits (ALCOA+)
- Computer System Validation (CSV) & ERES audits
- Cleaning validation and process validation audits
- Warehouse, cold chain, and distribution audits
Regulatory Standards Covered
Our GMP/GxP audits are aligned with:
- Schedule M & CDSCO Guidelines
- US FDA cGMP Regulations
- WHO-GMP
- EU GMP
- ICH Q7, Q9, Q10
- ISO & GxP requirements
This ensures your organization meets both Indian regulatory expectations and global compliance standards.
Risk-Based Audit Methodology
We apply a risk-based audit approach focusing on critical quality attributes (CQAs), critical process parameters (CPPs), and data integrity risks. Our audit methodology helps prioritize high-risk areas, minimize regulatory observations, and drive sustainable compliance improvements.
Audit Deliverables
- Detailed audit reports with objective evidence
- Critical, major, and minor observation classification
- Root cause analysis guidance
- CAPA recommendations and tracking support
- Management summary for decision-making
Why Choose Our GMP / GxP Audit Services?
- Regulatory-Experienced Auditors
Auditors with real CDSCO, FDA, and WHO-GMP inspection exposure. - Inspection-Focused Audits
Designed to mirror how regulators actually inspect facilities. - Actionable & Practical Outcomes
Clear, implementable recommendations—not generic findings. - Confidential & Independent Audits
Objective assessments with strict data confidentiality. - End-to-End Compliance Support
From audit execution to CAPA closure and re-audit readiness.
Industries We Serve
- Pharmaceutical Formulation Manufacturing
- API & Intermediate Manufacturing
- Medical Device Manufacturing
- Contract Manufacturing Organizations (CMOs)
- Clinical Research & Laboratories
- Life Sciences Start-ups and Scale-ups
Strengthen Compliance. Reduce Risk. Pass Audits with Confidence.
With increasing risk-based inspections and strict enforcement by global regulators, regular GMP/GxP audits are essential for maintaining compliance and business continuity. Our structured audit approach helps organizations identify gaps early, strengthen quality systems, and achieve sustained regulatory success.
