2016 and Method Validation - Pharmacy Technician Pulse

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2016

Method Validation

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

Although ANVISA has been an ICH member since 2016, the implementation plan of ICH guidelines is still ongoing. Published 29 February 2016. Key to the success of this process is the commitment of the ICH regulators to implement the final guidelines. It is expected that some local regulations beyond ICH will continue to exist.

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

BioProcess International 14 (2016): 38–43. 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. Smith, and R. Algorri, M., Cauchon, and M.

Documentation

Documentation FDA Communication Packaging

CMC Requirements for New Drug Registration in Latin America

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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