Query: container closure integrity study methodology
Correspondence from ANMAT regarding ANMAT-2020-0015. Type: deficiency. Risk: high. Category: Clinical.
Correspondence ID
COR-515
Type
deficiency
Application
Authority
ANMAT
Category
Clinical
Risk
High
Due Date
2025-05-01
Status
Draft
Owner
Nadia Petrova
Created
2022-08-13
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0015, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_515.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-05-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.