GDP guidelines for medicinal products are a set of rules and recommendations that aim to ensure the quality and integrity of medicinal products throughout the distribution chain.
These guidelines cover all activities related to the procurement, holding, supply, or export of medicinal products, except for supplying them to the public. They apply to all actors involved in the distribution of medicinal products, such as manufacturers, importers, wholesalers, distributors, and pharmacists.
The GDP guidelines for medicinal products are based on Article 84 and Article 85b(3) of Directive 2001/83/EC, which is the main legal framework for the regulation of medicinal products in the European Union.
The first version of the GDP guidelines was published by the European Commission in 1994, and was revised in 2013 to take into account recent advances in practices and technologies, as well as new requirements introduced by Directive 2011/62/EU, which aims to prevent the entry of falsified medicines into the legal supply chain.
The amended GDP guidelines (2013/C 343/01) came into force in the EU in September 2013. They aim to ensure the quality of all activities connected with the distribution of medicinal products (storage and transport conditions, etc.).
GDP guidelines for medicinal products are important for several reasons. First, they help to protect the health and safety of patients and consumers, by ensuring that the medicinal products they receive are of the appropriate quality, efficacy, and safety.
Second, they help to maintain the trust and confidence of the public and the authorities in the pharmaceutical sector, by preventing the infiltration of counterfeit, substandard, or adulterated medicines into the market. Third, they help to facilitate the trade and movement of medicinal products within and across the EU, by harmonizing the standards and procedures for the distribution of medicinal products.
GDP guidelines for medicinal products are also important for the measurement and comparison of GDP across countries and regions. Since medicinal products are a significant component of GDP, any discrepancies or errors in the distribution of medicinal products may affect the accuracy and reliability of GDP data.
By following the GDP guidelines for medicinal products, the distributors can ensure that the value and volume of medicinal products are correctly recorded and reported, and that the quality and integrity of the products are preserved throughout the distribution chain.
The GDP guidelines for medicinal products consist of nine chapters and two annexes, which cover the following topics:
This chapter describes the principles and requirements for establishing and maintaining a quality management system for the distribution of medicinal products. It covers aspects such as documentation, self-inspections, risk management, and continuous improvement.
This chapter specifies the roles and responsibilities of the personnel involved in the distribution of medicinal products, as well as the qualifications, training, and hygiene requirements for the staff.
This chapter defines the standards and specifications for the premises and equipment used for the storage and handling of medicinal products. It covers aspects such as security, temperature, humidity, lighting, ventilation, and cleaning.
This chapter outlines the types and formats of documents that are required for the distribution of medicinal products, such as orders, invoices, delivery notes, receipts, returns, and records. It also describes the procedures for the creation, approval, distribution, retention, and disposal of documents.
This chapter details the processes and procedures for the various operations involved in the distribution of medicinal products, such as purchasing, receiving, storing, picking, packing, dispatching, transporting, and delivering. It also covers the management of returned, recalled, rejected, falsified, or expired products.
This chapter explains the policies and procedures for handling complaints, returns, suspected falsified medicinal products, and medicinal product recalls. It covers aspects such as reporting, investigation, corrective and preventive actions, and communication.
This chapter describes the conditions and requirements for outsourcing any activities related to the distribution of medicinal products, such as transportation, warehousing, or testing. It covers aspects such as contracts, audits, and monitoring.
This chapter provides the guidelines and methods for conducting self-inspections of the distribution of medicinal products. It covers aspects such as planning, execution, reporting, and follow-up.
This chapter specifies the standards and procedures for the transportation of medicinal products, both within and outside the EU. It covers aspects such as vehicles, containers, packaging, labelling, temperature, humidity, security, and documentation.
This annex provides additional guidance on the temperature control during the transport of medicinal products, especially for products that require specific temperature conditions, such as cold chain products.
This annex provides a model of a technical agreement that can be used for outsourcing any activities related to the distribution of medicinal products.
The GDP Guidelines for medicinal products are available online in various languages on the website of the European Commission (link below). You can also find more information and resources on the GDP Guidelines for medicinal products on the website of the European Medicines Agency, or the website of the Swiss Federal Office of Public Health.
GDP is a key element of the quality assurance system that ensures the quality and safety of medicines throughout the distribution process. By complying with GDP, the organisations can demonstrate their commitment to delivering high-quality medicines to the patients and to protecting public health.
It is a regulatory requirement that you and your staff at all levels throughout the company receive GDP Guidelines training, before engaging the tasks and procedures involved within the registered and licensed premises.
If you need help, we can offer a free over-the-phone initial consultation on 0330 133 0920 or you can email us on info@ukgdpassociation.co.uk. Alternatively, use the contact form at the top right of this screen.
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EU GDP Guidelines (2013/C 343/01)
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