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.
pharmaphorum
DECEMBER 16, 2021
The conference taking place on 17 and 18 January 2022 in London, UK will bring together microbiology industry experts. Gain insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation. Exploring Robust Risk-Based Microbiological Control Strategy.
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ISPE
MAY 10, 2023
The ISPE QC/Analytical CoP was established in 2022 to provide a forum for knowledge sharing on a range of topics including out of specification (OOS) investigations, method validation, compendial harmonization, analytical methods lifecycle management, and implementing innovations, such as real-time release.
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.
ISPE
AUGUST 29, 2022
Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. HC is expected to have full implementation of ICH Q12 by late 2022. Reader note: This article was initially submitted to Pharmaceutical Engineering® during December 2021/January 2022. Streamlining Postapproval Submissions Using ICH Q12 & SCDM.
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