Our GDP Auditing Services

A medicine that is manufactured perfectly can still be ruined by the time it reaches a patient if the distribution chain fails. Temperature excursions, counterfeit infiltration, poor storage conditions, and broken traceability are all real risks in modern pharmaceutical supply chains. GxP Cellators provides GDP auditing services for everyone who touches the product between the factory gate and the patient. That includes wholesalers, distributors, third party logistics providers, cold chain specialists, and the manufacturers and marketing authorization holders who remain responsible for the products they release.

Global Regulatory Frameworks for GDP

EU GDP Guidelines

The EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use were published in 2013. Wholesale distribution is an important activity in the integrated management of the distribution chain. The current distribution network involves many players. These guidelines provide tools to assist wholesale distributors and prevent falsified medicinal products from entering the legal distribution chain. Wholesale distribution is defined in Article 1, point 17, of Directive 2001/83/EC. Any person acting as a wholesale distributor must hold a wholesale distribution authorization. Article 80, point (g), requires wholesale distributors to comply with GDP principles.

Summary of Key EU GDP Requirements:

Guidelines published 2013, replacing March 2013 guidelines
Wholesale distribution is important activity in distribution chain
Distribution network involves many players
Guidelines assist wholesale distributors
Guidelines prevent falsified products entering legal chain
Wholesale distribution defined in Article 1, point 17
Wholesale distribution authorization required
Article 80, point (g) requires GDP compliance
Definition not dependent on customs territory
Obligations apply to free zones and free warehouses
Other actors should also comply

WHO GDP Guidelines

The WHO Guidelines on Good Distribution Practices for Pharmaceutical Products provide an international reference for distribution operations. These guidelines are intended for implementation at all stages of the distribution and supply chain. Various role players should consider whether the relevant sections are applicable to their role. The storage, trade and distribution of pharmaceutical products is carried out by a variety of companies, institutions, and individuals. The nature of the risk involved is similar to that existing in the manufacturing environment, such as mix ups, contamination and cross contamination. GMP principles should be applied to distribution, including storage, distribution, transportation, packaging, labeling, documentation and record keeping practices.

Summary of Key WHO GDP Guidelines:

International reference for distribution operations
Intended for all stages of distribution and supply chain
Role players should consider applicable sections
Storage, trade and distribution by various entities
Risk similar to manufacturing environment
Mix ups, contamination, cross contamination risks
GMP principles should be applied to distribution
Storage, distribution, transportation covered
Packaging, labeling, documentation covered
Record keeping practices covered
Quality can be affected by inadequate control
GMP, GSP, GDP principles should all apply

MHRA GDP Requirements

The MHRA regulates GDP in the United Kingdom. UK GDP requirements align closely with EU GDP guidelines and are enforced through inspections of wholesale dealer license holders.

Summary of Key MHRA GDP Requirements:

Regulated by Medicines and Healthcare products Regulatory Agency
Align closely with EU GDP guidelines
Enforced through inspections
Wholesale dealer license holders inspected

Health Canada GDP Requirements

Health Canada regulates pharmaceutical distribution through the Food and Drug Regulations and the Guidance Document GUI-0069, titled Guidelines for Good Distribution Practices. These guidelines apply to all persons who distribute drugs in Canada, including wholesalers, distributors, and importers.

Summary of Key Health Canada GDP Requirements:

Food and Drug Regulations apply
GUI-0069 Guidelines for Good Distribution Practices
Applies to all persons distributing drugs in Canada
Wholesalers, distributors, importers covered

FDA DSCSA Requirements

The FDA regulates pharmaceutical distribution in the United States through the Drug Supply Chain Security Act. DSCSA requirements include product tracing, verification, and notification for prescription drugs. We audit compliance with DSCSA requirements for trading partners.

Summary of Key FDA DSCSA Requirements:

Drug Supply Chain Security Act
Product tracing requirements
Verification requirements
Notification requirements
Applies to prescription drugs
Audit compliance for trading partners

Audit Types We Provide

Wholesaler and Distributor Audits

Wholesale distribution authorization holders must demonstrate that they can store and distribute products without compromising quality. We audit premises, layout, and environmental control, temperature mapping and monitoring systems, qualification and validation of storage areas, stock rotation and expiry management, batch traceability and recall capability, returns, complaints, and falsified product handling, responsible person qualifications and duties, and documentation and record retention.

Summary of Wholesaler and Distributor Audits:

Premises, layout, and environmental control
Temperature mapping and monitoring
Qualification and validation of storage
Stock rotation and expiry management
Batch traceability and recall capability
Returns and complaints handling
Falsified product handling
Responsible person qualifications
Documentation and record retention

Third Party Logistics Provider Audits

When you outsource warehousing and transportation, you need assurance that your 3PL partner meets GDP standards. We audit 3PL operations for receipt, storage, pick and pack, transport, returns, and systems. This includes inbound inspection, temperature checks, damage reporting, segregation, controlled drug storage, quarantine areas, order accuracy, labeling, tamper evidence, vehicle qualification, lane validation, carrier oversight, assessment, disposition, destruction, WMS validation, data integrity, and interface controls.

Summary of Third Party Logistics Provider Audits:

Receipt: inbound inspection, temperature checks
Storage: segregation, controlled drug storage
Pick and pack: order accuracy, labeling
Transport: vehicle qualification, lane validation
Returns: assessment, disposition, destruction
Systems: WMS validation, data integrity

Cold Chain and Temperature Controlled Logistics

Cold chain products are especially vulnerable to distribution failures. We audit cold chain operations in detail, including refrigerated and frozen storage qualification, dry ice and passive shipper qualification, lane risk assessment and route validation, temperature excursion management and investigation, data logger selection, placement, and download, seasonal and worst case shipping studies, and last mile delivery controls. Temperature control is one of the most scrutinized areas in any GDP audit.

Summary of Cold Chain and Temperature Controlled Logistics:

Refrigerated and frozen storage qualification
Dry ice and passive shipper qualification
Lane risk assessment and route validation
Temperature excursion management
Data logger selection and placement
Seasonal and worst case shipping studies
Last mile delivery controls
Temperature mapping studies up to date
Monitoring devices calibrated
Alarm systems tested
Procedures for temperature excursions

Transportation Validation

Transportation validation is a core GDP expectation. We review your validation master plan, your qualification protocols, and your ongoing monitoring data. It is the responsibility of the wholesale distributor to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity. There should be written procedures for the operation and maintenance of all vehicles and equipment involved in the distribution process.

Summary of Transportation Validation:

Design qualification for shipper and route
Operational qualification for worst case
Performance qualification for repeat shipments
Seasonal testing for summer and winter
Requalification triggers and frequency
Deviation handling and excursion investigation
Vehicles and equipment suitable for use
Written procedures for operation and maintenance
Risk assessment of delivery routes

Traceability and Serialization

Product traceability is both a regulatory requirement and an anti counterfeit measure. We audit your traceability systems for accuracy and completeness, including serial number generation and aggregation, data upload to national and regional repositories, verification and decommissioning processes, aggregation hierarchy accuracy, reconciliation of commissioned and decommissioned units, and exception handling and data corrections.

Summary of Traceability and Serialization:

Serial number generation and aggregation
Data upload to national and regional repositories
Verification and decommissioning processes
Aggregation hierarchy accuracy
Reconciliation of commissioned and decommissioned units
Exception handling and data corrections

Recall and Returns Management

GDP requires that you have robust procedures for recalls and returns. There should be a system which includes a written procedure, to effectively and promptly recall pharmaceutical products known or suspected to be defective or counterfeit, with a designated person or persons responsible for recalls. All customers and competent authorities of all countries to which a given pharmaceutical product may have been distributed should be informed promptly of any intention to recall the product. A distributor should receive pharmaceutical product returns or exchanges pursuant to the terms and conditions of the agreement between the distributor and the recipient.

Summary of Recall and Returns Management:

Written procedure for effective and prompt recalls
Designated person responsible for recalls
Customers and authorities informed promptly
Progress recorded with final reconciliation report
Returned products assessed by authorized person
Quarantine and segregation of returned products
Returns process secure from counterfeit entry

Documentation Audits

In the world of pharmaceutical distribution, if it is not documented, it did not happen. This simple principle underpins every GDP audit. Documentation is the evidence that your distribution operations are conducted in a controlled, compliant, and quality focused manner. Without proper documentation, even the best practices are invisible to an auditor.

Summary of Documentation Audits:

Quality Management System documents
Temperature mapping and calibration certificates
Temperature logs and alarm test records
Training records and job descriptions
Supplier and customer qualification files
Agreements and contracts
Receiving, storage, picking, shipping records
Shipping validation and vehicle qualification
Recall and returns procedures

Supplier and Customer Qualification Audits

We audit supplier and customer qualification processes to verify that distribution partners meet GDP requirements. This includes due diligence, qualification, and ongoing monitoring.

Summary of Supplier and Customer Qualification Audits:

Audit supplier qualification processes
Audit customer qualification processes
Verify distribution partners meet GDP requirements
Due diligence and qualification
Ongoing monitoring

Mock GDP Inspections

We conduct mock GDP inspections that simulate the experience of a regulatory inspection. These audits prepare your team and identify gaps before the regulator does.

Summary of Mock GDP Inspections:

Simulate regulatory inspection experience
Prepare team for inspection
Identify gaps before regulator
Practice under realistic conditions

Who We Work With and Our Partners

Clients We Serve

We serve wholesale distributors, third party logistics providers, cold chain providers, pharmaceutical manufacturers, marketing authorization holders, importers and exporters, retail pharmacies, hospital pharmacies, medical device distributors, and veterinary product distributors.

Summary of Clients We Serve:

Wholesale distributors
Third party logistics providers
Cold chain providers
Pharmaceutical manufacturers
Marketing authorization holders
Importers and exporters
Retail pharmacies
Hospital pharmacies
Medical device distributors
Veterinary product distributors

Our Partners

We collaborate with logistics associations, cold chain organizations, technology vendors, training providers, regulatory consultants, and insurance providers.

Summary of Our Partners:

Logistics associations
Cold chain organizations
Technology vendors
Training providers
Regulatory consultants
Insurance providers

Our GDP Audit Process

Phase	Activities	Output
Planning	Scope, sites, products, regulatory framework	Audit plan
Document review	SOPs, validation reports, temperature data	Pre audit analysis
On site	Facility tour, interviews, record review	Working notes
Data review	Mapping reports, excursions, traceability data	Findings
Close out	Classification and CAPA discussion	Draft findings
Report	Final report with prioritized actions	Audit report
Follow up	CAPA verification and closure	Closure letter

Summary of GDP Audit Process:

Planning: scope, sites, products, framework
Document review: SOPs, validation, temperature data
On site: facility tour, interviews, record review
Data review: mapping, excursions, traceability
Close out: classification and CAPA discussion
Report: final report with prioritized actions
Follow up: CAPA verification and closure

Why Choose GxP Cellators for GDP Auditing

Auditors experienced in warehousing, transport, and cold chain operations
Coverage of EU, WHO, MHRA, Health Canada, and FDA GDP frameworks
Strong focus on temperature control and data integrity
Practical support for lane validation and shipper qualification
Reports designed for both quality teams and logistics leadership
Full confidentiality for commercial and network information

Summary of Why Choose GxP Cellators:

Auditors experienced in warehousing and transport
Coverage of EU, WHO, MHRA, Health Canada, FDA
Strong focus on temperature control
Practical support for lane validation
Reports for quality and logistics teams
Full confidentiality

Contact Us for GDP Auditing Support

If you need to qualify a distributor, assess a 3PL, or verify your cold chain validation status, our GDP auditing team can help. Contact us to discuss your distribution network.

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Source: GxP Cellators GxP Auditing page