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.). This new CoP is led by a recently formed Steering Committee comprised of seasoned subject matter experts.

Method Validation 98

Method Validation 98

ISPE

MAY 9, 2023

ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 29, 2022

As part of the change management process, personnel must manually find, view, and interpret the older data sets to establish a frame of reference for completing method validation exercises and compare the initial and optimized assays. The authors acknowledge Rita Algorri and Andrew Lennard for providing comments on the manuscript.

Documentation 52

Documentation FDA Communication Packaging 52