Pharmaceutical Technology

AUGUST 24, 2022

CAGR between 2020 and 2028. To ensure the quality of FCM assay performance in preclinical and clinical applications, several scientific organizations developed recommendations for FCM instrumentation and method validation.

Method Validation 52

Method Validation Immunization FDA 52

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

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Journal of Pharmaceutical Sciences 109 (2020):1427–1438. doi:10.1016/j.xphs.2021.09.046.

Documentation 52

Documentation FDA Communication Packaging 52