GDP Certification of Good Distribution Practices for the pharmaceutical industry.

In the pharmaceutical industry, quality and patient safety depend on medicines maintaining their integrity from the time they leave the manufacturer until they reach the point of use. This journey involves warehouses, transporters, distributors, brokers, consolidation points and transit areas where variables such as temperature, humidity, cleanliness, safety and traceability must be verifiably controlled.

To ensure this level of control, the European Union established the Good Distribution Practice (GDP), the standard that sets the minimum requirements to be met by wholesalers and logistics operators to preserve the quality and integrity of medicines throughout the supply chain.

The EU GDP Guidelines (2013/C 343/01) specify, among other things, how to manage facilities and equipment, how to qualify routes and packaging, how to monitor and record temperature, how to audit suppliers and subcontractors, and how to document and review deviations to demonstrate ongoing control in the face of inspections.

These guidelines, aligned with the international approach promoted by the WHO, are today the reference framework for pharmaceutical trade in Europe and in jurisdictions with recognition or adoption of equivalent practices.

In this context, Across Logistics is GDP certified, which guarantees processes and controls specifically designed for the health sector (including cold chain and enhanced traceability).

For the reader, manufacturer, importer/exporter, distributor or Operations area, this translates into a logistics partner capable of demonstrating compliance and maintaining product quality during storage and transport.

 

What is GDP certification?

GDP (Good Distribution Practice) is the European Union’s set of guidelines that ensure that medicinal products for human use maintain their quality, identity and integrity during distribution: from purchase and storage to supply or export (not including dispensing to the public).

Its regulatory basis is in Directive 2001/83/EC (Title VII) and the Guidelines on Good Distribution Practice of Medicinal Products for Human Use published in OJEU 2013/C 343/01. These guidelines provide tools to prevent the entry of falsified medicinal products into the legal chain and ensure continuous control of distribution.

In addition, there is a specific Commission guideline for the distribution of active substances (APIs), Guideline 2015/C 95/01, and a corpus of complementary international standards coordinated by the WHO.

In practice, the European framework is the benchmark for the pharmaceutical industry in the EU/EEA and is aligned with international best practices promoted by the WHO.

 

Who does it apply to and what activities does it cover?

🧭 Scope of activity: purchase, storage, supply and export of medicines; includes wholesale distributors and brokers (intermediation without stockholding).

🤝 Third parties involved: when activities are outsourced (e.g. transportation, warehousing, IT services), they must be under the control of the distributor through contracts, qualification and audits according to the outsourced activities chapter of the GDP guide.

🧪 APIs: their distribution is governed by the specific 2015 guideline; finished drugs are governed by the 2013 guideline.

 

Key concepts required by GDP

Quality system: documented processes, management review, quality risk management (QRM) and self-inspections, aimed at demonstrating continuous control.

👤 Responsible Person (RP): figure responsible for ensuring GDP compliance, with appropriate qualifications according to national regulations.

🧊 Temperature and environmental conditions: mapping and qualification of stores and routes, continuous monitoring and records; evaluation and management of deviations and CAPAs.

🖥️ Computerized systems: validated and with data integrity controls (ALCOA+), backups and traceability.

📦 Management of returns, recalls and complaints: procedures for investigating complaints, handling recalls and preventing non-conforming reintroductions.

🔐 Prevention of counterfeiting: origin and traceability controls of suppliers and customers, in line with the Falsified Medicines Directive.

 

Fundamental principles of GDP

Good Distribution Practices (GDP) establish the minimum requirements for the quality and integrity of medicines to be maintained throughout the supply chain.

The following is a summary of the pillars required by the European framework (2013/C 343/01) and its supplementary guidance for active substances (2015/C 95/01), in line with the EMA and WHO.

 

Quality Management System (QMS)

Quality policy and objectives, standard operating procedures (SOPs), quality risk management (QRM), management review, self-inspections, CAPA and change control.

Designation of a Responsible Person (RP) with authority and qualifications to ensure GDP compliance.

Risk-based approach for sizing controls according to product criticality, route and environment.

 

Personnel and training

Clear organizational structure, job descriptions, initial and ongoing training commensurate with the tasks (temperature, hygiene, safety, data).

Qualification records and periodic evaluation of competence.

 

Installations and equipment

Adequate areas for reception, quarantine, storage, order preparation and dispatch, with flows that avoid mixing, contamination or confusion.

Qualification of warehouses and critical equipment (thermal mapping, sensor calibration, preventive and corrective maintenance).

 

Control of temperature and environmental conditions

Continuous control and monitoring of the conditions specified by the drug holder (temperature and, when applicable, humidity).

Alarms, deviation management and product quality impact assessment; qualified packaging (passive/active) and route qualification to preserve condition during transport.

 

Operations: reception, storage and dispatch

Verification at reception (integrity of seals, damage, matching with documents), quarantine segregation and FEFO control / proper rotation.

Controls in preparation and verification of orders, and release of documents prior to shipment.

Procedures for returns, recalls and complaints with investigation, traceability and documented decision.

 

Transport under GDP control

Distributor’s responsibility to ensure that carriers and subcontractors operate under quality agreements, with route risk management, physical protection and recording of en route conditions.

Qualification of vehicles/containers when necessary and evaluation of thermal excursions.

 

Outsourcing and third party qualification

Outsourced activities (storage, transportation, IT, destruction, etc.) must be covered by technical contracts and audits/monitoring; qualified and verified suppliers and customers.

 

Documentation, records and data integrity

Complete, legible, traceable and retrievable records; retention periods in accordance with regulations.

Validated computerized systems with access control and audit trails, following good data integrity practices.

 

Counterfeit drug prevention and safety

Verification of legitimate origin and supplier/customer authorizations; controls to prevent the entry of counterfeit products into the legal chain.

Procedures for immediate notification and segregation in case of suspicion.

 

Incident and continuity management

Plans for emergencies (power outages, security incidents, logistical interruptions), with corrective actions and communication to affected parties/authorities when appropriate.

 

Together, these principles ensure that drug quality is maintained after manufacturing, i.e. during distribution, complementing GMP and aligning with EMA and WHO guidelines.

 

Requirements to obtain GDP certification

In the EU, compliance with Good Distribution Practices (GDP) is verified through inspections by the Competent Authorities (e.g. AEMPS in Spain).

When the result is favorable, a GDP compliance certificate is issued and published in the public database EudraGMDP, together with the Wholesale Distribution Authorizations (WDA).

This applies to wholesale distributors and, depending on the scope, to operators performing activities covered by the GDP guidelines; subcontracted activities must also be contractually controlled under the licensee’s quality system.

On a practical level, in order to obtain (and maintain) certification, authorities verify, through documentary and on-site audit, that the organization complies, among others, with the following minimum criteria of the GDP framework (2013/C 343/01 and specific guidance for active substances, 2015/C 95/01):

 

Quality Management System (QMS) commensurate with risk

Policy and objectives, SOPs, quality risk management (QRM), management review, self-inspections, CAPA and change control to demonstrate continuous control of the distribution process.

 

Responsible Person (RP)

Formal designation of a responsible person with authority and qualifications to ensure GDP compliance, including documentary release of operations and oversight of deviations and withdrawals. (National guidelines, such as HPRA, detail expectations and evidence).

 

Qualified facilities and equipment

Differentiated areas (reception, quarantine, storage, preparation and dispatch), thermal mapping of warehouses, sensor calibration and maintenance of critical equipment, access control and cleaning.

 

Control of temperature and environmental conditions

Continuous monitoring according to the specifications of the drug holder; alarms, deviation management and impact assessment; qualification of routes and packaging (passive/active) in transport.

 

GDP compliant transportation and third party control

Technical contracts with carriers and warehousing companies, qualification and audits of suppliers, recording of in-transit conditions and evaluation of thermal excursions.

Outsourced activities must be described and controlled under the outsourced activities chapter.

 

End-to-end operations and traceability

Receiving verification, quarantine segregation, proper rotation (e.g., FEFO), order picking verification and document release; robust returns, claims and recalls management with complete and retrievable records.

 

Computerized systems and data integrity

Validation of systems, access control, audit trails and ALCOA+ principles to ensure that evidence of compliance is reliable and traceable (NCA guidelines such as HPRA provide practical clarification).

 

Counterfeit prevention and legitimacy verification

Qualification of suppliers and customers, verification of authorizations and controls to prevent the entry of counterfeit drugs into the legal chain, in accordance with the European framework.

 

Typical preparation process (recommended approach)

🧭 Gap analysis against 2013/C 343/01 (and 2015/C 95/01 if applicable to APIs).

🗂️ QMS design/adjustment (SOPs, QRM, logs, change control, vendor qualification, mock recall, self-inspection plan).

🧊 Warehouse and route qualification (thermal mapping, temperature profiles, packaging, routing and acceptance criteria).

👥 Training and qualification of personnel, including PR.

🔍 Internal audits and audits of critical suppliers (carriers/warehousekeepers).

📝 Authority request/inspection and, if applicable, issuance and publication of the GDP certificate in EudraGMDP.

 

Key point: GDP is a minimum legal standard for the wholesale distributor and an operational requirement for any actor involved in activities covered by the guidelines.

Its compliance focuses on protecting drug quality and patient safety throughout distribution.

 

Benefits of GDP certification for the pharmaceutical industry

GDP (Good Distribution Practice) certification ensures that the quality and integrity of medicines is maintained during distribution, reducing risks to patients and the supply chain.

It is based on EU guidelines (2013/C 343/01) and, for active substances (APIs), on guidance 2015/C 95/01, consistent with WHO international guidance.

🛡️ Patient and product protection: By requiring quality systems, temperature control, traceability and deviation management, GDP reduces the risk of spoilage, contamination or tampering during storage and transport.

🌡️ Cold chain control and critical conditions: Continuous monitoring requirements, thermal mapping and qualified packaging/routing minimize out-of-specification excursions and their associated costs (shrinkage, rework, destruction).

🧾 End-to-end traceability and efficient recalls: Complete records, data integrity and procedures for returns/recalls allow you to investigate incidents, delineate affected lots and execute quick, documented recalls.

🧩 Third-party governance and operational continuity: Qualification and auditing of carriers/storage agents and contractual control of outsourced activities reduce risk at critical nodes in the chain; emergency plans favor continuity of supply.

📉 Reduced regulatory and reputational risk: GDP compliance aligns the organization with the inspection expectations of Competent Authorities; certificates and compliance history are published in EudraGMDP, providing verifiable transparency to partners and authorities.

⚙️ Operational efficiency and standardization: SOPs, quality risk management (QRM), self-inspections and CAPA promote predictable and reproducible processes, with fewer incidents, better lead times and less logistical variability.

🔐 Counterfeit prevention in the legal chain: Verification of the legitimate origin of suppliers/customers and integrity checks support the European objectives against counterfeit medicines, integrated in the 2013 revision of the GDP guidelines.

🌍 International alignment of practices: Convergence with WHO frameworks facilitates relationships with partners outside the EU and the adoption of comparable practices in regulated markets, improving chain interoperability.

In summary: GDP reduces clinical and operational risk, improves the ability to demonstrate compliance with inspections and provides confidence to the entire ecosystem (authorities, customers and patients). It is an enabler of quality and efficiency, not just a documentary requirement.

 

Challenges in the implementation of GDP

Although GDP certification brings strategic benefits to the pharmaceutical industry, its practical implementation presents significant challenges that must be managed in a planned manner.

These challenges are not only regulatory, but also operational, technological and human, and require sustained investments to maintain compliance over time.

 

Main implementation challenges

💶 Infrastructure and technology cost: Qualification of warehouses through thermal mapping, installation of continuous monitoring sensors, validation of IT systems or investment in specialized active/passive packaging require significant resources.

👩‍🏫 Continuous staff training: Initial training is not enough. Staff must be constantly trained in quality risk management (QRM), data integrity, deviation management and counterfeit security.

🌡️ Cold chain management in complex scenarios: Maintaining controlled conditions in long-distance international shipments, with multiple transit points and different climate zones, is an operational challenge that requires qualified routing and active monitoring.

🔄 Third-party management and outsourcing: Carriers, warehouse operators and IT providers must be qualified and audited. The biggest challenge is to ensure that all external players meet the same GDP standards.

🧾 Document complexity and traceability: The volume of records (electronic and paper), system validation and application of data integrity principles (ALCOA+) require robust systems and continuous audit controls.

⏱️ Maintenance of compliance over time: Compliance does not end with obtaining the certificate: it involves periodic audits, internal self-inspections and corrective actions to ensure continuous improvement and preparation for new regulatory inspections.

 

A necessary balance

The challenge is to balance cost, agility and compliance. Companies implementing GDP must maintain their competitiveness without sacrificing quality, which makes certification a strategic rather than a merely administrative process.

In short, the challenges associated with GDP certification oblige companies to professionalize their logistics management, adopt a culture of quality and rely on specialized logistics partners that already have this endorsement.

 

Across Logistics: your GDP certified logistics partner

Across Logistics has the GDP (Good Distribution Practices) accreditation, which certifies that it applies good distribution practices in the pharmaceutical and healthcare sector.

This certification guarantees that its logistics operation is designed to ensure the integrity and quality of the products throughout their journey from origin to destination.

In addition, its teams specialized healthcare teams understand the industry’s understand the challenges of the industry and are ready to provide support at every stage of the supply chain:

🛃 Customs services for both import and export, complying with current regulations.

🌡️ Temperature-controlled cargo ensuring that refrigerated, frozen or perishable goods arrive in optimal conditions.

⚙️ Special and industrial loads managing complex global projects efficiently and economically.

✈️🚢 Customized air and and sea freight, ideal for urgent or large volume ideal for urgent or large volume shipments.

🏢 Intelligent warehousing and distribution flexible and adapted to customer needs.

Thanks to this combination, GDP certification and specialized services, Across Logistics offers pharmaceutical companies:

✅ Peace of mind and confidence in the quality and traceability of the product.

🛡️ Reduction of regulatory and clinical risk in logistics.

🔗 A single provider for multiple critical services in healthcare distribution.