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article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

MARCH 29, 2023

The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics.

Documentation 52
Documentation Dosage Packaging Communication 52
article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

MARCH 29, 2023

The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics.

Documentation 52
Documentation Dosage Packaging Communication 52
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