GDP Inspection

Good Distribution Practice (GDP) is that part of quality assurance that ensures quality of products is maintained throughout the supply chain. In order to insure product quality product the Authority has set down principles and measures to be taken by distributors during distribution process.

The supply chain counts starts once the medical devices and diagnostic devices left the door of the manufacturing facility to carrier cargos, shipment, transportation vehicles, storage areas, whole sale, retail until reaches the end consumer. In order to ensure the product quality is maintain throughout the supply chain, TMDA conducts GDP inspections for all premises that store, sell, transport and distributes medical device and diagnostic devices and the inspections aims to verify implementation of GDP requirements.

Some of the GDP requirements are verified during pre-registration inspections of medical devices and diagnostics premises. However, these are also verified during routine inspections together with those which could not be verified during pre-registration inspections. The key requirements for GDP are based on Quality Management System (QMS) and they include the following:-

  1. Availability of structure administrative system,
  2. Adequate personnel with appropriate and adequate training,
  3. Proper premises in relation to the activity and product(s),
  4. Documentation of procedures for receiving of products, storage, dispatch, and transportation, recalled, returned, expired, complaints, substandard and falsified products, and
  5. Monitoring of the conditions i.e Temperature and Humidity where the product are stored and transported.

Detailed requirements for GDP implementation refers to the Guidelines for Business Licensing and Good Storage and Distribution Practices of Medicines and Medical Devices.

To view list of TMDA gazetted GDP inspectors click here.