ISPE

MARCH 29, 2023

For purpose of illustration used throughout this article, labels have been assigned to each CQA. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” From there, a preliminary list of CQAs is identified.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

For purpose of illustration used throughout this article, labels have been assigned to each CQA. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” From there, a preliminary list of CQAs is identified.

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. By employing an attribute-focused approach, an assessment of MW was performed based on a review of literature, process understanding, process performance, and historical PPG release testing data.

Documentation 52

Documentation FDA Packaging Communication 52