European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

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Method Validation Documentation FDA 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. April 2004.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. HC is expected to have full implementation of ICH Q12 by late 2022. Cauchon, PhD.

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Documentation FDA Communication Packaging 52

ISPE

MAY 10, 2023

My cousin, who now works for the FDA, has been studying malaria treatments for decades. “My grandfather died of pneumonia in the 1950s. Because he lived in China, he did not have access to penicillin, even though it was invented and being used to treat infections.

Method Validation 52

Method Validation FDA 52