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.
All pharmaceutical product distributors shall establish and maintain Quality System. There shall be documented quality policy describing the overall intentions and requirements of distributors regarding quality, authorized by the management.
There shall be an appropriate organizational structure with defined responsibilities of the personnel recorded as job descriptions.
A responsible person shall be appointed by the management for each distribution site, who shall have defined authority and responsibility for ensuring that a quality system is implemented and maintained.
Senior management shall ensure that all parts of quality system are adequately resourced with competent personnel and suitable and sufficient premises, equipment’s and facilities.
There shall be written and approved procedure for all the activities.
Deviations from established procedures shall be documented and investigated.
Appropriate corrective and preventive action (CAPA) shall be taken to correct deviations and prevent them.
Procedures for procurement and release shall be in place to ensure that appropriate pharmaceutical products are sourced only from approved suppliers and distributed by approved entities.
