Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

Why Should You Attend:

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.

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.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

• Analytical chemists
• QC managers
• QA managers
• Compliance managers
• Lab managers
• Sale managers
• Distributors and manufacturers of raw materials and ingredients
• Individuals who are responsible for storage, shipping and distributing products through the supply chain

Instructor Profile:

Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is currently the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. In 2011-2013, she took a sabbatical from Pharmalytik to join the USP Convention as the Director of Pharmacopeial Education Department, where she was responsible for their education programs worldwide.

Ms. Huynh-Ba is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an adjunct professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

She is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 president. She is the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel. Recently, she was elected to be one of the USP Council of Experts (2015-2020).

Ms. Huynh-Ba currently is a member of AAPS Publication Committee, Past-Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. She is an alternate councilor of American Chemical Society-Delaware section. She is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.

Ms. Huynh-Ba has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).

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