Vendor and Supplier Audits

Overview

Suppliers, vendors, contract manufacturers, laboratories, logistics providers, and other service partners can directly affect product quality, data integrity, supply continuity, and regulatory compliance.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent supplier and vendor audit services to help life-sciences organizations qualify new partners, monitor existing suppliers, assess outsourced GxP activities, and identify potential compliance risks.

Our audits are tailored to the type of material, service, process, system, or outsourced activity being assessed and can support both initial qualification and periodic re-evaluation.

MGS follows a practical, risk-based approach focused on the supplier’s capability, quality systems, regulatory compliance, technical controls, documentation, and ability to consistently meet client requirements.

Our Supplier & Vendor Audit Services

Supplier Qualification Audits

Assessment of prospective suppliers before approval to determine their technical capability, quality-system maturity, compliance status, and suitability for the intended use.

Periodic Supplier Audits

Risk-based reassessment of approved suppliers to confirm continued compliance, performance, and capability.

Contract Manufacturer Audits

Evaluation of contract manufacturing organizations involved in API, intermediate, finished dosage form, packaging, or other outsourced manufacturing activities.

Contract Laboratory Audits

Assessment of analytical, microbiological, bioanalytical, stability, and other testing laboratories supporting regulated activities.

Raw Material & Packaging Supplier Audits

Review of suppliers providing APIs, excipients, raw materials, primary packaging, printed packaging, and other critical materials.

Service Provider Audits

Assessment of third-party providers such as validation companies, calibration agencies, engineering vendors, computerized-system providers, and specialized GxP service organizations.

Logistics & Distribution Provider Audits

Evaluation of warehousing, transport, cold-chain, distribution, and third-party logistics providers.

Pharmacovigilance Vendor Audits

Assessment of CROs, safety database providers, literature vendors, medical information providers, and other outsourced PV partners.

Computerized System Vendor Audits

Evaluation of software vendors, cloud-service providers, hosting partners, and technology suppliers supporting GxP computerized systems.

Remote Vendor Assessments

Document-based and virtual assessments where on-site audits are not required or feasible, depending on risk and client requirements.

Key Audit Focus Areas

Depending on the type of supplier or vendor, MGS may assess:

• Quality Management System
• Organization and responsibilities
• Regulatory and licensing status
• Training and competency
• Facility and infrastructure
• Manufacturing or service controls
• Equipment and utility management
• Qualification and validation
• Data integrity
• Computerized systems
• Documentation and record control
• Material management
• Traceability
• Supplier controls
• Deviations and investigations
• CAPA
• Change control
• Complaints and recalls
• Business continuity
• Security and access control
• Outsourced activities
• Contractual responsibilities
• Quality agreements
• Performance monitoring
• Risk management
• Regulatory inspection history
• Continuous improvement

Risk-Based Supplier Qualification

Not every supplier requires the same level of oversight.

MGS can support clients in applying a risk-based approach by considering factors such as:

• Criticality of the material or service
• Impact on product quality or patient safety
• Regulatory significance
• Complexity of the outsourced activity
• Supplier performance history
• Previous audit findings
• Location and supply-chain risk
• Availability of alternative suppliers
• Data-integrity risk
• Business continuity considerations

This helps clients focus audit resources on suppliers that present the highest quality and compliance risk.

Our Audit Process

• Define Scope

Understand the supplier, material or service provided, criticality, intended use, client requirements, and applicable regulatory expectations.

• Prepare

Review questionnaires, previous audits, quality agreements, performance history, and available documentation to develop a focused audit plan.

• Conduct

Perform on-site or remote assessment through interviews, facility walkthroughs, process review, document examination, and evidence verification.

• Evaluate

Assess findings based on their potential impact on product quality, patient safety, data integrity, supply continuity, and regulatory compliance.

• Report

Provide a structured audit report with clear observations, supporting evidence, risk significance, and areas requiring improvement.

• Follow Up

Where required, support CAPA review, qualification decisions, remediation follow-up, and periodic reassessment.

Audit Deliverables

Depending on scope, MGS can provide:

• Supplier audit plan
• Pre-audit document review
• On-site or remote assessment
• Detailed supplier audit report
• Observation summary
• Risk-based finding classification
• Supplier compliance assessment
• CAPA review support
• Qualification recommendation support
• Follow-up audit support

Why Choose MGS for Supplier & Vendor Audits

Multidisciplinary Audit Capability

MGS can assess suppliers from quality, manufacturing, laboratory, engineering, validation, computerized-system, pharmacovigilance, and distribution perspectives.

Risk-Based Approach

Audit scope is aligned with the criticality of the supplied material, service, or outsourced activity.

Independent Assessment

Objective third-party audits help clients obtain an unbiased view of supplier capability and compliance.

Practical Findings

Audit reports clearly identify the gap, its significance, and the areas requiring corrective action or stronger oversight.

Flexible Audit Models

Support is available for initial qualification, periodic reassessment, focused audits, remote assessments, pre-contract evaluations, and follow-up audits.

Broad Supplier Coverage

MGS can support audits across multiple supplier and service-provider categories within the life-sciences supply chain.

Who We Audit

MGS can support audits of:

• API manufacturers
• Excipient suppliers
• Raw material suppliers
• Primary and secondary packaging suppliers
• Contract manufacturing organizations
• Contract testing laboratories
• Calibration and validation providers
• Engineering service providers
• Warehouses and logistics partners
• Cold-chain providers
• CROs and PV vendors
• Computerized-system vendors
• Software and cloud-service providers
• Other critical GxP suppliers and service partners