Why GDP matters
Good Distribution Practice (GDP) is the set of standards that ensures medicines maintain their quality and integrity throughout the supply chain – from the manufacturer to the pharmacy or hospital. Regulators in the EU, the Gulf, the Eurasian Economic Union and a growing number of African countries now inspect wholesalers against GDP requirements.
The main elements
- Quality management system with written procedures and responsibilities
- Qualified staff, including a responsible person for quality
- Premises and equipment suitable for storing medicines, with temperature mapping
- Documentation and records that allow full traceability of every batch
- Qualification of suppliers and customers
- Controlled transport with temperature monitoring where required
- Procedures for complaints, returns, suspected falsified products and recalls
- Self-inspection and continual improvement
Common gaps we see
In our consultancy work we regularly find the same weaknesses: temperature mapping never performed, suppliers not qualified beyond a price list, procedures written but not followed, and recalls that have never been tested. Each of these can lead to a failed inspection or, worse, a compromised product reaching a patient.
Where to start
Begin with a gap assessment against the WHO or EU GDP guideline, prioritise temperature control and traceability, and build procedures that your team can actually follow. Training and a culture of recording what you do matter more than the thickness of your quality manual.
GDP compliance is an investment that protects your licence, your customers and your patients. Unimax Pharm supports distributors with gap assessments, quality system design and training.