Query: container closure integrity study methodology
Correspondence from Swissmedic regarding SwissMedic-2021-0049. Type: commitment-request. Risk: low. Category: Clinical.
Correspondence ID
COR-349
Type
commitment-request
Application
Authority
Swissmedic
Category
Clinical
Risk
Low
Due Date
2025-01-16
Status
In Progress
Owner
Nadia Petrova
Created
2023-08-19
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0049, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_349.xlsxstudy_report_349.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.