ISPE

JUNE 2, 2023

The Steering Committee meets monthly to discuss QC-specific topics and to update progress towards knowledge sharing projects ( ISPE Guides , Pharmaceutical Engineering ® Magazine articles, ISPE Training , etc.).

Method Validation 98

Method Validation 98

ISPE

JANUARY 11, 2023

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. 1 US Food and Drug Administration.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

MAY 9, 2023

This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. Firmino 1 May 2023 The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 29, 2022

This article will examine the current global regulatory submission workflow for postapproval CMC changes and will propose principles to streamline regulatory submission authoring through the utilization of ICH Q12 concepts, in combination with SCDM. US Food and Drug Administration. Center for Biologics Evaluation and Research.

Documentation 52

Documentation FDA Communication Packaging 52