ISPE

MARCH 29, 2023

Published June 2008. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” [link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published June 2008. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” [link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Published 2008. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. Published May 2012.

Documentation 52

Documentation FDA Packaging Communication 52