Communication, Documentation and Method Validation

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Communication

Documentation

Method Validation

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

Documentation

Documentation FDA Communication Packaging

Pharmacy Technician Pulse

CMC Requirements for New Drug Registration in Latin America

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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