The Webinar will discuss the global nature of the pharmaceutical distribution supply chain and how temperature cycling studies can be done to support temperature excursions and shipping of drug products.
Shipping pharmaceutical products is more complicated than shipping any other items. Current GMP requires organizations maintain good storage and/or distribution practices of drug products throughout the supply chain as part of Quality Management System (QMS). There are specific guidelines and regulations involved in shipping as there are necessary steps to ensure that quality of the drug products are not compromised before they reach the consumer.
Temperature is a primary concern when shipping pharmaceuticals. Products must be shipped in containers that are well insulated. Temperature controlled shipments ensure that drug product are kept in optimal condition. Direct, non-stop routes are used to ensure that delivery is secured as well as other logistic considerations such as cameras in the warehouse, satellite tracking or visibility.
Introduce an overview and complexity of the storage and distribution of pharmaceutical products
Review observations on shipping practices
Goal of stability studies and environmental factors
Establish temperature cycling studies
Analytical testing for these products
Analytical chemists, QC managers, QA managers, compliance managers, lab managers, sale managers, distributors, manufacturers of raw materials and ingredients, and individuals who are responsible with storage, shipping and distributing products through the supply chain.
Upon completion of this session, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping condition in order to maintain quality of the drug product through expiry.