GDP Audits

Overview

Good Distribution Practice (GDP) audits help ensure that medicinal products are stored, handled, transported, and distributed under controlled conditions that preserve their quality, integrity, and traceability throughout the supply chain.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent GDP audit and assessment services for pharmaceutical warehouses, distributors, logistics providers, transporters, cold-chain service providers, and other organizations involved in the storage and distribution of regulated products.

Our audits evaluate quality systems, storage conditions, transportation controls, temperature management, documentation, traceability, security, outsourced activities, and supply-chain risks.

MGS follows a practical, risk-based approach to identify compliance gaps, strengthen distribution controls, and support ongoing regulatory and customer readiness.

Our GDP Audit Services

Warehouse Audits

Assessment of storage areas, material status control, temperature monitoring, segregation, environmental conditions, housekeeping, security, and warehouse quality systems.

Distribution & Logistics Audits

Evaluation of transportation processes, route controls, handling practices, carrier management, documentation, product protection, and delivery traceability.

Cold-Chain Audits

Assessment of temperature-sensitive storage and transportation systems, monitoring devices, excursion handling, qualification, mapping, packaging, and contingency controls.

Transporter & Logistics Provider Audits

Independent qualification and periodic assessment of transporters, freight providers, courier services, and third-party logistics partners.

Distributor & Wholesaler Audits

Review of distribution practices, product receipt, storage, order processing, dispatch, returns, recalls, traceability, and quality oversight.

Temperature Mapping & Monitoring System Audits

Assessment of warehouse mapping, transport-lane qualification, monitoring systems, sensor placement, calibration, alarm management, and excursion review.

Outsourced Distribution Activity Audits

Evaluation of contractual controls, quality agreements, responsibilities, performance monitoring, and oversight of outsourced GDP activities.

Pre-Inspection & Mock GDP Audits

Simulated inspection-readiness assessments to identify potential distribution and quality-system gaps before regulatory or customer audits.

Key GDP Audit Focus Areas

Depending on the audit scope, MGS may assess:

• Quality management system
• Organization and responsibilities
• Personnel training
• Premises and storage areas
• Temperature and humidity control
• Environmental monitoring
• Warehouse mapping
• Cold-chain management
• Transportation conditions
• Route and lane qualification
• Product receipt and dispatch
• Segregation and status identification
• Stock rotation
• Returns and rejected products
• Product recalls
• Traceability
• Security and prevention of unauthorized access
• Counterfeit-product controls
• Documentation and record retention
• Deviations and CAPA
• Change control
• Supplier and transporter qualification
• Outsourced activities
• Quality agreements
• Complaints
• Recall readiness
• Business continuity and contingency planning

Applicable GDP Perspective

Depending on the products, supply chain, and target markets, audit criteria may consider applicable requirements and expectations associated with:

• WHO GDP
• EU GDP
• PIC/S GDP expectations
• Applicable national distribution regulations
• Pharmaceutical cold-chain requirements
• Data-integrity and documentation expectations
• Quality-risk-management principles
• Other relevant regulatory and client requirements

The final audit criteria are defined according to the product profile, distribution model, regulatory market, and scope of activity.

Our Audit Process

• Define Scope

Understand the distribution model, facilities, products, transport network, outsourced activities, regulatory markets, and audit objectives.

• Prepare

Review available documents and prepare a risk-based audit plan focused on critical supply-chain and quality-system controls.

• Conduct

Perform on-site or remote assessment through warehouse walkthroughs, document review, interviews, system checks, and verification of operational practices.

• Evaluate

Assess observations based on their potential impact on product quality, traceability, temperature control, regulatory compliance, and supply continuity.

• Report

Provide a structured audit report describing observations, evidence, compliance significance, and areas requiring corrective action or improvement.

• Follow Up

Where required, support CAPA review, remediation planning, effectiveness assessment, and follow-up audits.

GDP Audit Deliverables

Depending on the agreed scope, MGS can provide:

• Audit agenda and audit plan
• Warehouse and distribution assessment
• Cold-chain compliance review
• Detailed GDP audit report
• Observation summary
• Risk-based observation classification
• Compliance-gap assessment
• CAPA review support
• Inspection-readiness recommendations
• Follow-up audit support

Why Choose MGS for GDP Audits

Supply-Chain Compliance Focus

Our audit approach evaluates not only storage areas, but also transportation, traceability, quality oversight, outsourced activities, and cold-chain risks.

Risk-Based Methodology

Audit focus is directed toward areas with the greatest potential impact on product quality, supply integrity, and regulatory compliance.

Practical Findings

Observations are presented clearly so clients can understand the gap, its significance, and where corrective action is required.

Cold-Chain Expertise

Special attention can be given to temperature-controlled storage, transport-lane qualification, excursion management, and monitoring-system controls.

Flexible Audit Scope

Audits can support qualification, periodic monitoring, vendor oversight, pre-inspection readiness, or focused assessments of specific distribution risks.

Who We Audit

MGS can support GDP audits of:

• Pharmaceutical warehouses
• Distributors and wholesalers
• Third-party logistics providers
• Transporters and freight partners
• Cold-chain service providers
• Depots and distribution centers
• Contract storage facilities
• Courier and specialty logistics providers
• Packaging and shipping service providers
• Other outsourced distribution partners