Stability Program to support Shipping and Distribution of Drug Products

Drug Product must maintain its identity, strength, quality and purity throughout its expiration. Physical, chemical and biological data are influenced by various environmental factors such as temperature, humidity and light. In current manufacturing environment, products can be shipped and distributed across different climatic zones. Seasonal changes as well as types of transportation can greatly affect the supply chain of the products.

This webinar will outline stability studies to support shipping and distribution of drug products. Upon completion of this session, attendees will learn key factors that would affect the shipping and distribution of drug products. you will 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.

Areas Covered in the Seminar:

• Goal of stability studies.
• Warning letters and observations on shipping and distribution practices.
• Short term excursion study.
• Thermal cycling study.
• Analytical testing for these studies.

Who Will Benefit:

• Pharmaceutical scientists
• Manufacturers or raw material and ingredients
• Analysts and lab managers
• QA managers and personnel
• Regulatory affairs