ISPE

MARCH 29, 2023

For purpose of illustration used throughout this article, labels have been assigned to each CQA. 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. 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 initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics. 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. Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on.

Documentation 52

Documentation FDA Packaging Communication 52