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.,

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Documentation FDA Communication Packaging 52

ISPE

MAY 9, 2023

The information results from the authors’ experience working in a global company and managing successful drug registrations in the Latin American region. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., the site where development occurs versus where commercialization is intended).

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

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FDA Documentation Labelling Method Validation 71