GDP describes the proper distribution and shipping practices of pharmaceutical and medical products for human use and regulations for the materials and product transportation between destinations and sites…
According to Drugs & Cosmetics Act 1940 and additional amendments specify the conditions to be fulfilled to sell, stock, exhibit or offer for sale or distribute drugs and medicinal products.
The quality system should ensure that the right products are delivered to the right destination within a satisfactory time period under appropriate environmental conditions and controls. Distribution is an essential activity and is part of the supply chain of pharmaceutical and medicinal products. GDP aspects include acquisition, storage, distribution, transportation, documentation and record keeping practices.
It is essential to maintain adequate controls during distribution in order to maintain the quality and shelf life of pharmaceutical products. Pharmaceutical and medical product distribution should be carried out according to the principles of Good Distribution Practices. A validated track & trace system should be capable finding a specific product in case of a recall procedure. In general, GDP risks are similar to GSP risks and can also be managed by assimilation of GMP principles. GDP guidelines will ensure the quality pharmaceutical products during the distribution process.
The guidelines are intended for all personnel involved in distribution of pharmaceutical products, from storage to dispensary or directly to the patient. For additional information see U.S. Pharmacopeia chapter <1079> Good Storage and Distribution Practices for Drug Products and World Health Organization Annex 5 good distribution practices for pharmaceutical products.
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