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 has been a member of IPEC Americas committees since 2001 and is the current Chair and member of the IPEC Americas Executive Committee. She is past chair of the Compendial Review Committee. Priscilla also participates in the International Food Additives Council and the Personal Care Products Council.