Good Distribution Practice (GDP) Requirements
What is GDP?
Good Distribution Practice (GDP) is a set of quality standards for the storage, handling, and distribution of medical devices. GDP ensures that devices maintain their safety, quality, and performance characteristics throughout the supply chain — from the manufacturer's warehouse to the end user.
Who must comply with GDP
GDP requirements apply to all licensed importers and wholesalers of medical devices in Singapore. GDP compliance is assessed as part of the dealer's licence application and through ongoing HSA monitoring.
Key GDP requirements
GDP for medical devices typically covers:
- Premises and storage conditions: adequate storage space, environmental controls (temperature, humidity) appropriate to the device type, segregation of different products and product statuses (e.g. quarantine, approved, rejected);
- Handling and transport: procedures to prevent damage, contamination, or deterioration during handling and transport; cold chain management for temperature-sensitive devices;
- Inventory management: stock rotation (FIFO/FEFO), regular stock checks;
- Distribution records: complete, accurate records of all inward and outward movements of devices — see Distribution Records;
- Returns and recalls: procedures for handling returned goods and executing FSCAs and recalls;
- Training: all staff handling devices must be trained in GDP procedures relevant to their role.
GDP and the QMS
GDP requirements are integrated into the ISO 13485-aligned QMS. The QMS should include documented GDP procedures that are consistently implemented and subject to internal audit.