Official Good Distribution Practice (GDP) legislation label:

• European Commission Guidelines of 5 November 2013 on good distribution practices for medicinal products for human use (2013/C 343/01).

Good Distribution Practice (GDP) Overview:

Good Distribution Practices (GDP) define the requirements that wholesale distributors must meet in order to ensure the quality of medicines and prevent falsified medicines from entering the legal supply chain. This includes the procurement, storage, transportation of medicines, ensuring that the products reach the right recipients within an acceptable period of time. Medicines are a special product, the improper storage, transportation, and use of which are dangerous to health and life, therefore their path from the manufacturer to the consumer must be strictly controlled to prevent substandard medicines from entering the market.

Good Distribution Practice (GDP) process

• Preparatory stage – Logistics and warehousing processes are assessed, a quality management system (QMS) is implemented, and a responsible person is appointed.

• Internal audit – Self-monitoring is performed, potential non-compliance is identified, and procedures are adjusted.

• Certification audit planning – A certification body is selected, an audit date is agreed upon, and the organization prepares for the inspection.

• Basic GDP audit – Evaluates warehousing, transportation, documentation management, and non-conformance resolution processes.

• Report and implementation of corrective actions – If deficiencies are identified, the organization eliminates them within a specified time frame and submits corrective actions.

• Issuance of a GDP certificate – If all requirements meet the standard, a GDP certificate is issued, valid for 3 years.

• Surveillance audits – Periodic inspections ensure ongoing compliance with GDP requirements.

Benefits of Good Distribution Practices (GDP)

• Helps companies avoid legal problems related to EU competition rules.
• Reduces the risk of monopolistic activity by ensuring fair competition in the market.
• Provides clear guidelines for companies that collaborate with other organizations.
• Increases transparency and market stability by encouraging innovation and fair business practices.