GDP - Good Distribution Practice

Ensuring the quality, identity, and integrity of pharmaceuticals and medical devices at every stage of the distribution chain is of critical importance, both as a legal requirement and for patient safety. In Turkey, compliance with GDP is mandatory for all organizations involved in pharmaceutical distribution under the supervision of the Ministry of Health and the Turkish Medicines and Medical Devices Agency (TİTCK). A&A Consulting offers a comprehensive consulting service that takes into account both national regulations and the requirements of the EU GDP guidelines.

All processes under GDP are prioritized and controlled within the framework of Quality Risk Management. Temperature-controlled storage, cold chain management, and vehicle qualification are standardized. A GDP documentation system comprising policies, procedures, work instructions, and a record hierarchy is established. The authorization and compliance of all parties in the supply chain are verified. Return and recall procedures are established to ensure the rapid removal of counterfeit and defective products from the market. An internal audit mechanism is established; all GDP responsible parties and operational staff receive regular training. The process is completed with preparation for TİTCK inspections and on-site accompaniment services on the day of the inspection.