Audit & Assurance
Good Distribution Practice Audits
Independent GDP audits for wholesale distributors, 3PL providers, cold chain operators and licensed dealers, conducted against EU GDP Guidelines and UK MHRA requirements.
Executive Overview
The integrity of the pharmaceutical supply chain depends on the consistent application of GDP principles at every stage of distribution. Medicinal products that leave a licensed manufacturer in full GMP compliance can be compromised by inadequate storage conditions, unqualified distribution networks or poor handling practices at any subsequent point in the chain. EU GDP Guidelines 2013/C 343/01 set the minimum standards that wholesale dealers and their supply chain partners must meet.
GDP audits provide organisations with independent assurance that their distribution operations, and those of their logistics partners, meet regulatory expectations. Wholesale dealers are required to audit suppliers and customers as part of their quality system obligations. Pharmaceutical manufacturers are expected to extend their quality oversight into the distribution chain via qualification and periodic reassessment of their wholesale partners.
Sthira Assure GDP audits are conducted by assessors with direct experience of pharmaceutical distribution operations, GDP inspection outcomes and cold chain qualification requirements. We assess against the specific requirements of EU GDP Guidelines, MHRA GDP guidance and applicable national requirements, providing findings that are directly relevant to the regulatory environment in which your organisation operates.
Regulatory Frameworks
- EU GDP Guidelines 2013/C 343/01
- MHRA GDP Guidance
- EU Directive 2001/83/EC
- FMD 2011/62/EU
- WHO GDP Guidelines
- IATA Temperature Control
Common Compliance Risks
Temperature Excursion Management
GDP inspectors consistently identify inadequate temperature excursion management as a critical risk area. Organisations frequently lack documented excursion assessment procedures, risk-based decision frameworks for product disposition and evidence that temperature-sensitive products have been continuously monitored throughout the distribution chain.
Qualification of Storage Facilities
Wholesale dealers and logistics providers often fail to qualify storage facilities to the standard required under EU GDP Guidelines. Temperature mapping studies are either absent, outdated or conducted without appropriate seasonal variation. Cold rooms and refrigeration units must demonstrate suitability before use, a requirement frequently verified only on inspection.
Supplier and Customer Qualification
GDP guidelines require wholesale dealers to verify that they only supply and receive medicinal products from other licensed entities. Inspectors find that customer and supplier qualification procedures are often inadequate, with verification of wholesale dealer licences not performed at appropriate intervals or in sufficient depth.
Falsified Medicines Directive Compliance
FMD verification obligations under EU Directive 2011/62/EU continue to present operational challenges, particularly around returns handling, system integration and exception management. Non-compliant returns handling is a consistent inspection finding for organisations that have not formalised their FMD workflows.
Scope of Services
Common Audit Findings
Frequently Asked Questions
Who needs a GDP audit?
Any organisation that holds a wholesale dealer's licence or handles medicinal products in distribution is subject to EU GDP Guidelines. This includes wholesale distributors, hospital pharmacies with wholesale activities, parallel importers, brokers and 3PL providers handling pharmaceutical products.
How does GDP audit scope differ from GMP audit scope?
GDP audits focus on the distribution quality system, storage conditions, transport arrangements, supplier and customer qualification, traceability, returns handling and the Responsible Person system. GMP audits address manufacturing quality systems. Organisations that both manufacture and distribute may require both.
Can you assess cold chain compliance for biologics and vaccines?
Yes. We assess cold chain infrastructure, temperature monitoring systems, excursion management procedures and qualification of temperature-controlled vehicles for organisations handling biologics, vaccines and other temperature-sensitive medicinal products.
What regulatory authority frameworks do you assess against?
Our GDP audits are conducted against EU GDP Guidelines 2013/C 343/01, MHRA GDP guidance, WHO Model Guidance for storage and transport of time and temperature-sensitive pharmaceutical products, and applicable national transpositions.
Request a GDP Audit
Contact our team to discuss your GDP audit requirements, distribution network scope and regulatory framework.