Good distribution practice is a set of standards for the sourcing, handling, storage, and transportation of medicines for human use and their active ingredients. Wholesale licence and authorisation holders must comply with good distribution practice to ensure the quality, safety, and security of medicinal products throughout the pharmaceutical supply chain.
Good distribution practice is important because it greatly affects public health. Any mistake in distribution can cause shortages, delays, and even the introduction of falsified medicines into the market.
Another reason why GDP is important in pharma is that it aids in product traceability, which can be a huge factor during official investigations of quality issues or incidents involving pharmaceutical products.
Overall, following good distribution practices protects wholesale distributors from situations that would not only damage their reputation in the industry but also harm the general public and lead to a huge loss in customers.
A quality system should have the organizational structure, procedures, processes, resources, and actions needed to demonstrate that the distributor meets quality requirements. Quality management or the quality system must include a documented quality policy as well as authorized procurement and release procedures.
Wholesalers are also required to assess potential risks to the quality of products and follow quality risk management principles. Quality systems should be regularly reviewed and revised according to the recommendations of the risk assessments conducted.
