ISPE

MARCH 29, 2023

Published 12 September 2002. “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality–M4Q(R1) Quality Overall Summary of Module 2 Module 3: Quality.” link] 10 a b c US Food and Drug Administration. “A A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together.” Cauchon, T.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published 12 September 2002. “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality–M4Q(R1) Quality Overall Summary of Module 2 Module 3: Quality.” link] 10 a b c US Food and Drug Administration. “A A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together.” Cauchon, T.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52

Documentation FDA Packaging Communication 52