What is Good Distribution Practice (GDP)?
Good Distribution Practice (GDP) is the EU standard for distributing medicines. The EU GDP guidelines set out how wholesalers source, store, transport and document medicinal products so that their quality and authenticity are preserved from the manufacturer to the pharmacy. They apply to every business that holds a wholesale distribution authorisation (WDA).
Source: EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
T. LozerCompliance Strategy Specialist · entroit GmbH
· Updated
Where GDP comes from
The European Commission published the guidelines on Good Distribution Practice of medicinal products for human use on 5 November 2013, reference 2013/C 343/01. They are based on Directive 2001/83/EC, and each EU member state enforces them through its national medicines law and its wholesale distribution authorisation. The Commission has issued separate GDP guidelines for active substances.
Who GDP applies to
GDP applies to every business that procures, holds, supplies or exports medicines at wholesale level. This includes:
- pharmaceutical wholesalers and full-line distributors
- manufacturers that distribute their own products
- pharmacies that hold a wholesale distribution authorisation
- parallel importers
- brokers of medicinal products, who have their own chapter in the guidelines
Each of these businesses designates a Responsible Person who is accountable for GDP compliance. The national competent authority checks this during inspections.
What the GDP guidelines require
The guidelines have ten chapters:
- Quality management
- Personnel
- Premises and equipment, including computerised systems
- Documentation
- Operations, from sourcing and goods receipt to delivery
- Complaints, returns, suspected falsified medicines and recalls
- Outsourced activities
- Self-inspections
- Transportation
- Specific provisions for brokers
In the warehouse, these become concrete duties. You only sell stock after checking and releasing it at goods receipt. Returns and suspect stock are held in quarantine. Every storage location and every shipment has a temperature record. Every batch can be traced to the customer. Stock is picked by First Expired, First Out (FEFO). And you rehearse a recall before you need one.
How GDP differs from GMP
GMP stands for Good Manufacturing Practice and governs the manufacture of a medicine up to batch release. GDP takes over from there and covers the supply chain up to delivery to the pharmacy, hospital or doctor. A manufacturer that distributes its own products must meet both.
For software, wholesale still works to a GMP standard. The GDP guidelines require essentially the same of computerised systems as EU GMP Annex 11.
What GDP requires of your inventory management system
Chapter 3 of the guidelines requires you to validate a computerised system before it is brought into use. You must show that it achieves the intended results accurately, consistently and reproducibly. Access control, data backup and a record of every change come on top.
In the end, it is your business that is GDP compliant, not the software. But your inventory management system for pharmaceutical wholesale has to handle quarantine, batch traceability and the audit trail in a way that lets you meet the requirements.