Adherence of cGMPS for atypical actives for use as active pharmaceutical ingredients

Abstract

Atypical Actives play a significant role in the manufacturing of over-the-counter (OTC) and prescription (Rx) drugs. The FDA expects manufacturers of Atypical Actives to follow the ICH Q7 Guidance Document for current Good Manufacturing Practices (cGMPs); however it has been widely reported that not all Atypical Actives are manufactured in accordance with this Guidance. What do Industry Professionals think the level of cGMPs should be to manufacture Atypical Actives? To answer this question, surveys were distributed to manufacturers and industry professionals to determine if higher or lower cGMP standards were required to manufacture “Atypical Actives”. The data set revealed that respondents employed by a member company of IPEC, believe that the cGMP standards for “Atypical Actives” should not be as strict as for “typical” Active Pharmaceutical Ingredients.