ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). September 2006. www.fda.gov/media/71023/download 50 Yu, L. AAPS Journal 16, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52