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
Ms. Zawislak has over 30 years’ experience in Regulatory Affairs and Quality functions. Currently with The Dow Chemical Company, Priscilla is the Global Regulatory Affairs Advocacy Manager for Dow’s Food, Pharma and Medical Solutions business. Priscilla is the current Chair of IPEC-Americas and has been an active member of IPEC Americas committees since 2001 and is a member of the IPEC Americas Executive Committee. She is also the Vice-President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. 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.