In a regulated life sciences supply chain, vendor compliance is as critical as internal compliance. Our Third Party / Vendor Assessment Audit services help pharmaceutical and life sciences organizations evaluate, qualify, and monitor suppliers to ensure consistent quality, regulatory compliance, and supply chain integrity.
We conduct independent, risk-based vendor audits to assess third-party compliance with GMP/GxP, regulatory requirements, and quality agreements, minimizing risks related to product quality, data integrity, and regulatory observations.
Comprehensive Vendor & Third-Party Audit Solutions
Our audits are designed to assess whether suppliers and service providers consistently meet regulatory and contractual obligations.
Scope of Third Party / Vendor Assessment Audits
- Supplier Qualification Audits
- API, intermediate, and excipient manufacturer audits
- Packaging material and labeling vendor audits
- Raw material and consumable supplier audits
- Contract & Service Provider Audits
- Contract Manufacturing Organization (CMO) audits
- Contract Research Organization (CRO) audits
- Third-party testing laboratories and calibration service audits
- Warehousing, logistics, and cold-chain service provider audits
- Quality System & GMP/GxP Audits
- Quality Management System (QMS) evaluation
- SOP adequacy and implementation assessment
- Change control, deviation, CAPA, and complaint handling review
- Data Integrity (ALCOA+) and documentation practices review
- Risk-Based & Regulatory Readiness Audits
- Vendor risk assessment and categorization
- Schedule M, CDSCO, and US FDA compliance checks
- WHO-GMP and EU GMP gap identification
- Audit readiness for regulatory inspections and customer audits
Regulatory Standards & Guidelines Covered
Our third-party and vendor audits are aligned with:
- Schedule M & CDSCO Guidelines
- US FDA cGMP Requirements
- WHO-GMP
- EU GMP
- ICH Q7, Q9, Q10
- GxP & Data Integrity Requirements
This ensures suppliers meet both Indian regulatory requirements and global compliance expectations.
Risk-Based Audit Methodology
We apply a risk-based audit approach considering material criticality, supplier history, process complexity, and regulatory impact. This helps organizations focus audit efforts on high-risk vendors and build a robust supplier qualification program.
Audit Deliverables
- Detailed vendor audit report with objective evidence
- Risk-based observations (critical, major, minor)
- Supplier compliance rating and approval recommendation
- CAPA expectations and follow-up support
- Executive summary for management and QA review
Why Choose Our Third Party / Vendor Assessment Audit Services?
- Independent & Objective Audits
Unbiased assessments with strict confidentiality. - Regulator-Aligned Audit Approach
Designed to meet CDSCO, FDA, and global inspection expectations. - Practical & Actionable Findings
Clear recommendations for supplier improvement. - Supply Chain Risk Reduction
Prevents quality failures and regulatory non-compliance. - End-to-End Vendor Compliance Support
From supplier qualification to re-audit and performance monitoring.
Industries We Support
- Pharmaceutical Formulation Manufacturers
- API & Intermediate Manufacturers
- Medical Device Companies
- Contract Manufacturing Organizations (CMOs)
- Laboratories and Service Providers
- Global and Domestic Supply Chains
Build a Compliant & Reliable Supply Chain
With increased regulatory focus on outsourced activities and supplier oversight, effective Third Party / Vendor Assessment Audits are essential. Our structured and risk-based audits help ensure supplier reliability, regulatory compliance, and uninterrupted business operations.
