Query: container closure integrity study methodology
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0067. Type: deficiency. Risk: low. Category: Quality.
Correspondence ID
COR-367
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Quality
Risk
Low
Due Date
2025-03-18
Status
Overdue
Owner
Marcus Webb
Created
2022-11-28
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0067, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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_367.xlsxstudy_report_367.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-18 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.