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A Proposal for a Comprehensive Quality Overall Summary

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g.,

Documentation 52
Documentation Dosage Packaging Communication 52
article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g.,

Documentation 52
Documentation Dosage Packaging Communication 52
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