ISPE

MARCH 29, 2023

Published 12 September 2002. 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] 10 a b c US Food and Drug Administration. “A A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published 12 September 2002. 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] 10 a b c US Food and Drug Administration. “A A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together.”

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 2002. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally.

Documentation 52

Documentation FDA Packaging Communication 52