Dear All,
Good morning.
As per MAPP 5019 REV 2, Gross content, net container content need to add in specification.
Can we just add container content (after reconstitution) and Assay value meets specifications and skip Gross content?Any lead to explain in brief.Any possibility of RTR if we are not adding Gross content as per MAPP 5019 REV 2.
As product developed in 2021,though submission batches manufactured in Nov 2022, Rev 2 effective in June 2022.Can we submit without Gross content in specification? Any risk associated with filling?
Really appreciate your feedback.
Regards,
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sapna rathi
Regulatory specialist
AHME
India
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