Comparative Account of Diverse Regulatory Guidelines for Storage and Transportation of Pharmaceuticals

Good Pharmaceutical Storage and Distribution Practices (GS&DP) are the component of Quality Management System (QMS) that promises the quality of the pharmaceuticals through controlling various activities allied to storage and distribution operations procedures. There are a number of International Regulatory Guidelines, which toss light over the requirement, and importance of Quality and Quality Assurance. Pharmaceutical products require controlled storage and transit conditions in order to ensure their quality. Poor regulatory controls over the interstate transportation and warehousing complicate the matter impacting the product quality, efficacy and safety. Indian drug regulatory guidelines are inadequately defined and thus the impact of varied climatic conditions during transport and warehousing is still not appropriately evaluated and studied. These can have serious repercussion on the physical, chemical and microbiological attributes of the drug product. The present study intended for comparing the regulatory guidelines of other countries and agencies with Indian regulatory standards and the need to improvise the latter to bring under purview the measures that can prevent the product instability. Further, based on the evaluation studies on certain model pharmaceutical products, suggestive evaluation methodologies will be proposed from Indian perspective to account for the go-ahead changes a product undergoes during the supply-distribution channel, which the manufacturer needs to assess and furnish to the central drug regulatory agency such as DCGI prior to getting marketing approval.