Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.

Why Should You Attend:

Current GMP requires organizations maintain label storage condition of drug products throughout the supply chain as part of the Quality Management System (QMS). Regulations and guidelines in this area are not well defined, yet pharmaceutical companies must take necessary steps to maintain quality of commercial products during transport and distribution. Most organizations focuses on the efficacy of the products, but this is rarely the concern. The increase of degradation products or new impurities is the main issue when materials are not stored and shipped according to their label.

Transportation of pharmaceutical products could involve long and complex routes that may require temperature controlled environments and issues such as temperature excursions, packaging breakdowns, incorrect shipping or custom delays could cause detrimental effects and cause loss of product sales. Therefore, it is a challenge to balance between the additional cost of shipping and the product quality.

This webinar will discuss the complexity of the storage and distribution of pharmaceutical products and the effect of environmental factors during transportation and distribution and key factors to be considered to set up temperature-cycling studies to support excursions during shipping of pharmaceutical products depending on their label storage conditions.