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Abstract:
Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Good Pharmaceutical Storage Practices are often accompanied by the concept of Good Distribution Practice (GDP). In this regard just like GDPs, GSPs is also a part of the Quality Management System. To maintain the original quality of pharmaceutical products, every party active in the distribution chain has to comply with the applicable legislation and regulations. Good Storage Practices (GSPs) also play an integral role in various Pharmaceutical and Pharmacovigilance-oriented companies, organizations and institutions. Every individual in the pharmaceutical industry is responsible to maintain drug substance or drug product for its identity, strength, quality and purity. Every activity in the distribution of pharmaceutical products should be carried out according to the principles of GMP, good storage practice (GSP) and good distribution practice (GDP) as applicable All drugs should be stored at stipulated temperature areas, protected from excessive light, dust, and humidity. The loss of potency during the storage may lead to decrease in the efficacy of the drug product.In this particular article, the Good Distribution and storage practices with respect to European Union are discussed and specific storage conditions from the proposed EU Guidelines were highlighted.
Key Words: Distribution, Quality Management system, Warehouse, Wholesale
Introduction:
Good storage and distribution practices may apply to all organizations and individuals involved in any aspect of the storage and distribution of all the drug products. Storage and distribution may involve the complex movement of products around the world, differences in documents and handling requirements and communication among various entities in the supply chain. The good storage and distribution practices would facilitate the movement of the drug product throughout the supply chain that is controlled, measured and analyzed for continuous improvements and should maintain the integrity of the drug product in its packaging during storage and distribution. [1]
The commission has published the EU Guidelines on Good Distribution Practice (GDP) in 1994. Revised guidelines were published in March 2013 [2] in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive 2011/62/EU. [3]
* EU Commission has revised the Guideline on Good Distribution Practices.
* The new...