Good Distribution Practice (GDP)

Good Distribution Practice is a set of requirements and procedures for companies involved in the entire logistics chain of medicinal products.  It is made up of companies involved in the following processes:

• transportation of medicinal products
• storage of the aforementioned
• freight forwarders and pick and pack companies 

The Pharmaceutical Law, which has been amended as of 08 February 2015, introduces a number of new obligations on entrepreneurs involved in the wholesale trade or brokering of  medicinal products. For detailed guidelines, see the Regulation of the Minister of Health of 13 March 2015 on the requirements of Good Distribution Practice (Journal of Laws of 10 March 2017, item 509). It aims specifically to prevent falsified medicinal products from entering the legal supply chain as required by Directive 2011/62/EU of 8 June 2011.

The Good Distribution Practice principles have been developed on the basis of European Commission guidelines and European Parliament Directive (2011/62/EU of 8 June 2011) - the Good Distribution Practice (GDP).

The requirements set out in the aforementioned documents apply to companies operating both nationally and internationally.

Medicinal products - is the term used for many products such as:

• medical products
• vaccines
• medicines
• food supplements and foodstuffs for particular nutritional uses
• psychoactive substances
• cosmetics
• herbs
• medical devices

All companies handling the above products are required to establish and document the operation of a quality assurance system.  Such a system must be kept up-to-date and include, among other things, a risk assessment of the operations carried out.

The above-mentioned documentation (different for different areas - transport; storage, etc.) should include, among others, a database of suppliers, recipients, procedures and other documents describing the scope of activities of a given entity.

DPD certification is a proof of implementation of Good Distribution Practice principles. The certification gives you the opportunity to provide services in the pharmaceutical industry. DPD certification is carried out on the basis of the European Commission's guidelines of 5 November 2013 on Good Distribution Practice for medicinal products for human use and the mandatory provisions of the Polish law. The DPD certificate is issued for a 3-year period, during which the company shall undergo two surveillance audits. DPD certification includes:

• review of DPD documentation,
• audit of the DPD system in an organisation,
• preparation of a DPD audit report,
• issuing a DPD certificate/statement, confirming compliance with the guidelines required by legal regulations at European and national level on Good Distribution Practice.

The DPD certificate is a guarantee of good practice, which is fundamental to ensuring medicinal product safety, quality and integrity throughout the supply chain. The Good Distribution Practice system is dedicated to all those involved in the wholesale trade of medicinal products, from manufacturing companies, wholesalers, warehouses and companies that organise and carry out transport.