Manufacturing & Supply Chain
Good Distribution Practice.
We help pharmaceutical companies, wholesalers, and logistics service providers implement and maintain GDP compliance—from gap analysis and distributor qualification to cold chain validation.
What are the risks associated with inadequate GDP compliance?
GDP non-compliance jeopardizes drug quality and regulatory approvals:
- Temperature fluctuations during transport or storage can compromise heat-sensitive products
- Lack of distributor qualification: Medicines are distributed through channels that do not comply with GDP
- Incomplete traceability: in the event of a recall, affected batches cannot be fully identified
- GDP audits conducted by regulatory authorities (EMA Guideline 2013/C 343/01) reveal deficiencies that jeopardize wholesale distribution licenses
Have you qualified and audited all of your distribution partners for compliance with GDP?
Our services.
We implement and audit GDP systems for the entire supply chain.
GDP Gap Analysis & Readiness Assessment
Comprehensive review of the existing distribution system against EU GDP guidelines (2013/C 343/01): personnel requirements, facilities/equipment, documentation, operations (receiving, shipping, returns), complaints and recalls, and self-inspections.
GDP System Implementation & SOP Development
Development of GDP-compliant SOPs for all distribution-related processes: incoming goods inspection, storage, order picking, shipping, and cold chain management. Training of all employees involved.
Distributor Qualification & Audits
Qualification and auditing of distributors and logistics partners in accordance with GDP. Audit reports with CAPA recommendations. Quality agreements with logistics partners. → [Compliant Procurement Excellence](/expertise/compliant-procurement-excellence)
Cold Chain Qualification & Validation
Qualification of cold storage rooms and transport containers (Lanes Study). Validation of transport routes for temperature-sensitive pharmaceuticals. Temperature mapping and monitoring systems.
Frequently Asked Questions About Good Distribution Practice.
Who needs a GDP wholesale license?
All companies that distribute pharmaceuticals at the wholesale level—that is, that resell them between manufacturers and pharmacies or hospitals. In Germany: a wholesale license under Section 52a of the German Medicines Act (AMG), which requires a facility that complies with Good Distribution Practice (GDP). Manufacturers with their own distribution networks may include a wholesale license as part of their operations.
What is the difference between GMP and GDP?
GMP (Good Manufacturing Practice) applies to the manufacture of medicinal products. GDP (Good Distribution Practice) applies to the storage and distribution of medicinal products after they leave the manufacturer. GDP builds on GMP—GDP-compliant distribution is essential to ensure that the quality achieved during manufacturing reaches the patient.
What is a Lanes Study for temperature-sensitive products?
A transport lane study is a validation study for transport routes: Temperature sensors are carried along during actual or simulated transport (under worst-case conditions: summer/winter) and the data is recorded. It demonstrates that the product’s temperature limits are maintained throughout the entire transport process.
When must a drug recall be reported in accordance with GDP?
All parties in the supply chain must immediately implement the marketing authorization holder’s (MAH) recall instructions and identify and isolate affected batches. Wholesalers must report recall quantities to the MAH within 3 business days. Regulatory authorities will be notified by the MAH. Full traceability is a requirement of Good Distribution Practice (GDP).
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