Pharmaceutical Stability Testing to Support Global Markets

Introduction.- Regulatory Perspectives on Product Stability.- Current International Harmonization Efforts.- Update on the WHO Stability Guideline.- Development of a Regional Guideline for the Eastern Mediterranean Region.- The Challenge of Divers Climates: Adequate Stability Testing Conditions for India.- Requirements for South East Asian Markets.- The Role of USP Monographs in Stability Testing.- Regulatory Requirements for Stability Testing of Generics.- Stability Design for Consumer Healthcare Products.- Challenges of Drug/Devices Pharmaceutical Products.- Practical Challenges of Stability Testing on Nutraceutical Formulations.- Setting Tolerances for Instrument Qualification.- The Concept of Quality-by-Design.- Forced Degradation and Its Relation to Real Time Drug Product Stability.- Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation.- Stability and Safety Concerns of Repackaged Products.- Packaging-Induced Interactions and Degradation.- An Overview of Physical Stability of Pharmaceuticals.- Stability of Split Tablets.- Temperature Monitoring During Shipment and Storage.- Introducing Science-based Quality by Design Concept to Analytical Methods Development.- Optimizing Stability Data Package to Facilitate NDA/MAA Approval.- Maximize Data for Post Approval Changes.- Use of Statistics to Establish A Stability Trend Matrixing.- Setting Specifications for Drug Substances.- Setting Specifications for Drug Products.- Highlights of Investigating Out-Of-Specifications Test Results.- Building and Developing Relationships with 3rd Party Laboratories.- Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced.- Outsourcing Stability Testing: A Tool for Resource and Risk Management.

Kim Huynh-Ba is the founder and Technical Director of Pharmalytik (www.pharmalytik.com). She has twenty two years of experience in various analytical areas of pharmaceutical development and a primary focus in stability sciences. Prior to Pharmalytik, she held positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She has been advising pharmaceutical companies including companies operating under Consent Decree on harmonization and optimization of analytical best practices since 2001.

In addition to her consulting activities, Kim is a short course instructor and organizer on topics ranging from cGMP compliance and quality issues to stability programs under sponsorship of global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, many other international training groups. She is the founder and past co-chair of the AAPS Stability Focus Group, and an active member of the Pharmaceutical Stability Discussion Group (PSDG). She serves on the Governing Board of Eastern Analytical Symposium (EAS). She currently is Chair of the AAPS APQ e-Learning Committee and the 2008 EAS Short Course Program. She is a member of USP's Prescription/Non-Prescription Stakeholder Forum and also USP Reference Standard Project Team.

Kim Huynh-Ba is a recipient of the 2008 AAPS APQ Service Award and 2008 Recognition Award of AAPS Regulatory Section. She also received the 2001 DPCAA Leadership Award.

Kim Huynh-Ba has authored numerous technical publications and book chapters. She is invited frequently to present at national and international conferences. She is the editor of the Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices, which has been recognized as a practical reference book in the stability community.