By definition, an Atypical Active is an “excipient, food additive or personal care ingredient” that is being used as an “active ingredient” in a formulation. In some cases it is the only ingredient. Emerging regulatory initiatives are changing the way these materials have historically been handled, e.g. FDASIA and EU's Falsified Medicines Directive.
- New regulatory implications
- What are appropriate GMPs to use for Atypical Actives
- If Regulators apply ICH Q7 API GMPs to manufacture of “Atypical Actives” what could happen?
- Potential Strategy for Next Steps
- Proposed Solutions
Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; Vice President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences.
Ms. Zawislak Priscilla has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products. She is IPEC-Americas Immediate Past-Chair and is the current Vice President of the IPEC Federation. Priscilla is the Global Regulatory Affairs Advocacy Manager for Dupont’s pharmaceutical and nutrition business. Her responsibilities include regulatory advocacy for excipients, APIs and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Inc.’s Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products and Quality Manager at FMC BioPolymer (now DuPont Health & Nutrition).
Ms. Zawislak is the Immediate Past Chair of IPEC-Americas, has been a member of IPEC-Americas committees since 2001 and is a member of the Executive Committee. She is also Vice President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She is an IPEC-Americas representative on several USP related committees including the Excipients Project Team, Compendial Process Improvement Team, General Notices Project Team, has served as Chair for several Stakeholder Forums, and is a Delegate to the USP Convention. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.