Good Distribution Practices of Pharmaceuticals and APIs

It is crucial that pharmaceutical products adhere not only to high-quality standards as per Good Manufacturing Practice but also maintain their quality and integrity throughout the entire supply chain, up to the patient.

This is where Good Distribution Practice (GDP) comes into play. Good Storage and Distribution Practices (GSP, GDP) are paramount throughout the life cycle of pharmaceutical products and Active Pharmaceutical Ingredients (APIs). The pharmaceutical product network, as we know, is complex and involves multiple parties, compounded by increasing criminal activity introducing counterfeit drugs into the legal supply chain. European guidance emphasizes quality systems, risk management principles, and delineates clear responsibilities and processes. It is now inevitable for pharmaceutical distributors to establish a quality system by defining responsibilities, processes, and risk management principles related to their activities.

Given the distances medicinal products must travel and various external factors they may encounter post-production, licensed companies aim to ensure their products reach patients without spoilage or falsification. The primary objective of this training course is to offer a comprehensive perspective on who should implement these practices and when, along with discussing mechanisms to demonstrate the maintenance of quality, integrity, potency, and identity of the finished drug product from raw material to the supply chain's end.