Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
What are GDP Guidelines for Medicinal products?
Good Distribution Practice (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 parties 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.) These amended guidelines are what are used today by pharmaceutical distributors in the EU and UK.
Why are GDP guidelines important?
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 are designed to maintain the trust and confidence of the public and the authorities in the pharmaceutical sector, and help to prevent 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 harmonising 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, along with the established SOPs (Standard Operating Procedures) set in place for their activities, 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.
What are the main elements of the GDP Guidelines?
The GDP guidelines for medicinal products consist of nine chapters and two annexes, which cover the following topics:
Chapter 1 - Quality Management
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.
Chapter 2 - Personnel
This chapter addresses personnel, highlighting the need for competent staff with clearly defined roles and responsibilities. A Responsible Person (RP) must be appointed with the appropriate qualifications and authority to ensure GDP compliance. Companies must employ sufficient staff. All personnel should receive initial and ongoing GDP training. Training must be documented and assessed for effectiveness.
Chapter 3 - Premises and Equipment
Chapter 3 mandates that wholesale distributors must maintain suitable, secure, and well-structured premises, including appropriately designated receiving and dispatch areas that protect products from exposure and unauthorised access. Separate clearly designated zones are required for storage or returned, rejected, recalled, or potentially falsified medicinal products. Equipment and installations must be adequate, validated and maintained to ensure proper storage and distribution, including systems for environmental monitoring and control. Computerised systems should also be qualified and validated to ensure their reliable operation.
Chapter 4 - Documentation
Chapter 4 stresses that documentation must be clear, accurate, controlled and readily available to ensure traceability of all distribution activities. Records should be kept for a minimum of 5 years, with superseded or obsolete versions removed. Paper and electronic systems must be secure, reliable and validated to maintain data integrity.
Chapter 5 - Operations
Chapter 5 outlines that all distribution operations must follow written procedures to ensure product quality and integrity. Activities such as receipt, storage, picking, packing, and delivery must protect products from contamination, mix ups, damage, and falsification. Segregation, stock rotation, and temperature control are required, with accurate records maintained for traceability.
Chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products and Recalls
Chapter 6 requires written procedures to manage complaints, returns, suspected falsified medicines, and recalls. Complaints should be clear as to whether they relate to a quality or service-related issue. They must be investigated and documented with corrective and preventative actions implemented. Returns may only be returned to saleable stock upon the authorisation of the RP. Recalls must be prompt, effective and well documented. The Recall procedure should be tested at least once per year in the event of no live recalls having taken place. Falsified medicines must be reported to the Competent Authority and Marketing Authorisation holder and quarantined.
Chapter 7 - Outsourced Activities
Outsourced activities must be covered by a written agreement which clearly defines the responsibilities of all parties. The contractor’s suitability must be evaluated, and activities regularly monitored for compliance. The RP retains overall responsibility for GDP compliance and any non-conformances by the outsourced activity provider can impact on your own compliance status. Documentation, audits, and quality agreements are essential to maintain control and accountability.
Chapter 8 - Self-Inspections
WDA holders must perform regular self-inspections of their Quality Management System to verify compliance with GDP. Inspections should be documented, conducted by impartial staff and cover all distribution activities. Where findings are noted, these should be managed via a Deviation and CAPA process and monitored for effectiveness. The performance of self-inspections contributes to continuous improvement and helps to identify risks to product quality, supply chain integrity, and GDP compliance.
Chapter 9 - Transportation
Medicinal products must be transported under conditions that maintain the quality and integrity of the product. Vehicles and equipment should protect against contamination, damage, and temperature excursions. Written procedures mist cover delivery, security, and documentation. Transport providers must comply with GDP, with risks assessed, contracts in place and monitoring and reporting mechanisms in place.
Annex 1 - Guidance on Temperature Control During Transport
This annex provides guidance on maintaining required temperature ranges during transport. It emphasises validated temperature-controlled systems, proper thermal packaging and refrigerated vehicles, along with regular calibration and monitoring of temperature equipment to ensure product integrity throughout transport.
Annex 2 - Model of Technical Agreement between contract giver and acceptor
Annex 2 outlines a model technical agreement between contract giver and acceptor, defining responsibilities, compliance with GDP, documentation, and quality assurance. It ensures both parties maintain product integrity, assess competence, and communicate effectively throughout the storage and distribution process.
How can I access the GDP guidelines?
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, the MHRA Rules and Guidance for Pharmaceutical Distributors (also known as the Green Guide), 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.
Paradigm Shift Consulting Ltd offer a comprehensive range of courses designed to address all aspects of GDP operations. We run an online GDP Webinar for RPs and Management every month, involving a thorough training schedule covering all 10 chapters of the EU guidelines complete with vivid examples of how things can go wrong and of course, education as to what you must do to remain within compliance.
If you wish to know more, call us for a free initial consultation, or you can use the contact form on our ‘Contact Us’ page. Alternatively, call us on 0330 133 0920 if your requirements or issues are more complex.
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