Who is it for?

The DPD system, or Good Distribution Practice, is a set of procedures and requirements for businesses involved in the wholesale distribution of medicinal products (excluding veterinary medicinal products) and medical devices. This includes all participants in the supply chain:

• pharmaceutical wholesalers,
• intermediaries in the wholesale trade of medicinal products,
• medicinal product warehouses,
• companies involved in the transport or organisation of the transport of medicinal products,
• companies involved in the preparation of consignments or the distribution of medicinal products. 

Compliance with the requirements of Good Distribution Practice is the responsibility of both domestic and international companies.

Information about the standard

Good Distribution Practice (GDP) is a set of procedures and requirements designed to ensure the proper handling of medicinal products throughout the supply chain, from the manufacturer to the pharmacy. Adherence to these principles guarantees that, throughout the long and complex logistics process involving a number of subcontractors and service providers, the quality, integrity, safety and legality of the product in question will be maintained.

At European Union level, Good Distribution Practice was implemented pursuant to the European Commission Guidelines of 5 November 2013. In Poland, the requirements of GDP are set out in the Regulation of the Minister of Health of 13 March 2015, issued pursuant to the Pharmaceutical Law, and the Regulation of the Minister of Health of 17 June 2016 amending the regulation on the requirements of Good Distribution Practice.

Under the GDP, it is the responsibility of the business operator to establish and implement a Quality Assurance System and subsequently monitor and document its operation. Specific requirements relating to the wholesale distribution of medicinal products concern, amongst other things:

• quality management,
• staff qualifications,
• premises and their equipment,
• documentation,
• operational activities (e.g. storage, packaging, transport, complaints, returns, destruction of medicinal products),
• activities outsourced to subcontractors,
• internal audits.

Compliance with Good Distribution Practice is subject to inspection by the State Pharmaceutical Inspectorate.

Benefits of implementation

The implementation and certification of the DPD system bring a range of benefits, relating both to the internal operations of the company and to its reputation among current and potential business partners.

Proper implementation of Good Distribution Practice allows for:

• compliance with applicable legal requirements,
• maintaining the highest quality of medicinal products supplied,
• reducing costs associated with substandard products,
• constant monitoring of compliance with quality assurance principles within the company,
• clearly defining the scope of management responsibilities,
• good organisation of work across all company departments,
• increased control over other links in the supply chain,
• rapid implementation of preventive or corrective actions.

A certificate to this standard serves as reliable confirmation of compliance with GDP requirements. Holding such a certificate has a positive impact on the company’s reputation among customers and business partners. Good Distribution Practice certification enhances the company’s competitive advantage, contributing to an improvement in its market position.