Key GMP requirements – what must a pharmaceutical wholesaler comply with?

Obtaining a licence for the wholesale distribution of medicinal products is only the beginning. The real challenge lies in establishing and maintaining a quality system that complies with the requirements of Good Distribution Practice – a system that operates on a day-to-day basis, not just on the day of a GIF inspection. Below, we discuss areas of key practical importance.

Quality Management System and Responsible Person

The cornerstone of DPD’s requirements is a documented quality management system (QMS) covering all processes related to the handling of medicinal products – from goods receipt, through storage and transport, to dispensing and the handling of complaints. The system must be described in the Site Master File – a document outlining the organisation, processes and infrastructure of the warehouse, which is the primary document reviewed during GIF inspections. The central role in the system is that of the Responsible Person (RP) – a requirement unique to the DPD, with no equivalent in standards such as ISO 9001. The RP must meet the formal requirements set out in pharmaceutical law (relevant education, professional experience), is permanently employed and bears personal responsibility for compliance with DPD requirements at the warehouse. It is the RP who signs qualification documents, is responsible for liaising with the GIF and oversees the implementation of corrective actions following inspections or audits.

The quality management system must include documented procedures for all key processes, a system for managing documentation and records, internal audits conducted regularly (at least once a year), and a mechanism for managing changes and corrective actions.

Temperature and Storage Conditions Management

Monitoring storage and transport conditions is one of the most technically demanding areas at DPD – and one in which the highest number of non-compliances are identified during GIF inspections.

The warehouse must ensure and document that appropriate conditions are maintained for each product category:

• Products stored at room temperature (15–25°C) – require constant monitoring of temperature and humidity in the warehouse, with real-time data logging
• Products requiring refrigeration (2–8°C) – cold rooms must be qualified (IQ/OQ/PQ), and refrigeration systems must be covered by a preventive maintenance plan and emergency procedures
• Deep-frozen products – require specialist infrastructure and documented procedures for dealing with breakdowns

A key requirement is the qualification of premises and equipment – the warehouse must demonstrate that its infrastructure is capable of maintaining the required conditions under all operating conditions, including at maximum warehouse occupancy and during extreme seasons. Qualification must be documented and repeated following any significant change to the infrastructure.

The transport of medicinal products must take place under conditions that ensure the required temperature parameters are maintained throughout the entire duration of the delivery. Transport vehicles or containers must be qualified, and temperature data must be recorded and archived for each delivery.

Supplier qualification, traceability and the management of falsified medicines

The qualification of suppliers and recipients is one of the cornerstones of the DPD system. A wholesaler may only purchase medicinal products from entities holding the appropriate authorisations – manufacturers, importers or other pharmaceutical wholesalers. Before establishing a business relationship, every supplier must be formally qualified: their authorisation must be verified (available in the GIF register and the European EudraGMDP database), and the results of the qualification must be documented. Similarly, recipients are verified – the wholesaler dispenses medicinal products exclusively to authorised entities (other wholesalers, pharmacies, hospitals).

Traceability is the requirement to be able to track the path of every medicinal product in both directions – from supplier to recipient and vice versa. In practice, this means keeping records of every transaction with full details of the product (name, form, dose, batch number, expiry date), supplier and recipient. In the event of a product recall, the wholesaler must be able to identify all recipients of a given batch within a few hours and initiate the product recall procedure.

The management of falsified medicinal products is an area that has taken on particular significance following the implementation of Directive 2011/62/EU (the so-called Falsified Medicines Directive) and the EMVS/PLMVS system for verifying the authenticity of medicines. Every wholesaler involved in the distribution of medicines subject to serialisation must be connected to the national verification system (in Poland: PLMVS), scan the 2D codes on packaging upon receipt and dispatch of products, and archive the verification results. Products suspected of being counterfeit must be immediately isolated, and the information must be forwarded to the GIF and the marketing authorisation holder.

Compliance with Good Distribution Practice involves a process covering work organisation, documentation and oversight of the entire distribution chain for medicinal products. Find out how we support companies in implementing GDP.