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This webinar addressed the impact of multi-sourcing of excipients on the manufacture, quality, safety, and efficacy of drug products. The webinar covered assessment of each excipient source (for equivalency/comparability) in terms of fitness for purpose in a given drug formulation/product, and the potential impact of changing source from a pharmaceutical formulator's perspective. Reliance solely on specification equivalence may miss differences in other excipient properties, such as composition profiles. Impurities may be a misnomer especially if minor components contribute to the functionality of the excipient. Other supplier considerations include GMPs, process capabilities and reliability.
Supplier inequivalence in finished product performance is a Critical Material Attribute awaiting specification!
• The implications of excipient variability and sourcing and the means by which risk can be minimized.
• How excipient from different manufacturers can perform differently in a drug formulation and could have an impact on a user’s quality systems
• How excipient complexity contributes to unpredictable product performance
• How to mitigate excipient-related risk
Dr. Moreton has over thirty years experience in the pharmaceutical industry, mainly as a formulation scientist developing a variety of different dosage forms, but also in QA/QC and Technical Support in excipients and drug delivery. Most recently, he has been responsible for the development of clinical and commercial drug products and associated analytical methods, working with clients, licensing partners and contractors.
Dr. Moreton has authored and co-authored scientific papers, articles and book chapters, and lectured extensively on excipients, drug delivery, preformulation and formulation at universities, training courses and symposia in the U.S., Europe and Japan. He is a past Chair of IPEC-Americas.
Brian Carlin is Director QbD/Regulatory at DFE Pharma. He previously worked at FMC, SmithKline Beecham & Richardson Vicks. He is a Fellow of the Royal Pharmaceutical Society, and holds honorary Professorships at DeMontfort University and University of Maryland.
He is the recipient of the 2014 IPEC One World Award for Regulatory Excellence, and the 2012 IPEC Foundation Award for Industry Research Achievement. He is the immediate past chair of the IPEC Americas QbD Committee.
He has a doctorate in Interfacial Rheology from London University, and a degree in Pharmacy from the University of Aston in Birmingham.
Doug has 28 years of experience in Quality Control Laboratory testing. Doug has been an active member of IPEC-Americas for 5 years, participating in the CRC-Compendial Review Committee and the Users Network. He actively participates in the PDG Harmonization activities as a liaison for the IPEC-Americas CRC committee, as well as the IPEC-Federation board. Doug is actively engaged in global harmonization of compendial General Chapters, Informational Chapters, excipients monographs, and regulatory guidance requirements. Doug routinely supports the mission of delivering scientifically valid global standards which ensure patient safety.