What Are the Main Elements of GDP Guidelines in 2026?

GDP Guidelines: The Main Elements

The GDP guidelines (Good Distribution Practice) for medicinal products consist of ten working chapters and two annexes, which cover the following topics:

Chapter 1 – Quality Management

We start the GDP guidelines with describing 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 Records should be kept for a minimum of 5 years, with superseded or obsolete versions removed.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 guidelines 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 within the GDP guidelines. 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.

Chapter 10 – Specific Provisions for Brokers

Brokerage within the EU is a licensable activity. Brokers must register with their competent authority and are required to have a limited quality management system that ensures customers and suppliers are qualified, that there is a mechamism for reporting of falsified medicines, that a record of all medicinal products brokered is retained, that complaints are managed, recalls are reviewed and actioned and that all records are maintained for review by the competent authority.

Brokers are never allowed to buy, sell or store medicines, only negotiate transactions between another legal or natural person.

Annex 1 – GDP Guideline on Temperature Control During Transport

This annex provides GDP guidelines 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?

You can also find a free pdf of the EU GDP Guidelines and more information and resources on the European Medicines Agency website.

In addition, the MHRA Rules and Guidance for Pharmaceutical Distributors, also known as the Green Guide, which incorporates the EU GDP Guidelines along with further guidance, is available to purchase on the Pharmaceutical Press website.

GDP Training

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 via our GDP Training website. 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.

Help and Support

If you wish to know more you can use the GDP questionnaire on our Contact Us page. Alternatively, call us on 0330 133 0920 for a free 5-minute consultation if your requirements or issues are more complex.