Identifying TPPs and CQAs for a Lyophilized Parenteral Product.

Autor: Miller, Denise L., Shults, Carrie A., Trappler, Edward H.
Předmět:
Zdroj: Pharmaceutical Technology; Jun2018, Vol. 42 Issue 6, p38-41, 4p
Abstrakt: The article discusses issues associated with integrating quality risk management for managing pharmaceutical products. Topics discussed include physical, chemical, biological and microbiological properties for critical quality attributes (CQAs) for technology transfer to manufacturing, considerations for limiting L-Arginine use in pediatrics or sugar content for people with diabetes, and assessment and development of essential CQAs.
Databáze: Complementary Index