Guidelines on good distribution practices for pharmaceutical Products

The guidelines on Good Distribution Practices (GDP) for pharmaceutical products aim to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. The document sets out steps to assist in fulfilling the responsibilities involved in the different stages within the supply chain, including procurement, purchasing, storage, distribution, transportation, documentation, and record-keeping practices.

The guidelines are intended to be applicable to all entities involved in any aspect of the storage and distribution of pharmaceutical products, from the premises of the manufacturer to the person dispensing or providing medical products directly to a patient. This includes manufacturers, wholesalers, brokers, suppliers, distributors, logistics providers, traders, transport companies, and their employees.

The document highlights the importance of maintaining the original quality of pharmaceutical products throughout the distribution chain, emphasizing that each activity in the distribution process should be carried out according to the principles of Good Distribution Practices (GDP) as applicable. It also stresses the need for collaboration between all parties involved in the supply chain to prevent the exposure of patients to spurious and adulterated products.

The guidelines cover various aspects of pharmaceutical product distribution, including personnel training, quality system management, premises and storage facilities, temperature control, transportation, and document traceability. The document emphasizes the importance of maintaining proper records, conducting regular stock reconciliation, and investigating discrepancies to ensure the quality and integrity of pharmaceutical products.

Overall, the guidelines aim to provide a framework for entities involved in the distribution of pharmaceutical products to adhere to Good Distribution Practices (GDP) principles, ensuring that pharmaceutical products are stored, transported, and distributed in a manner that maintains their quality and identity throughout the supply chain.