Query: container closure integrity study methodology

Correspondence from National Medical Products Administration regarding NMPA-2021-0064. Type: information-request. Risk: low. Category: Quality.

Correspondence ID
COR-364
Type
information-request
Application
NMPA-2021-0064
Authority
National Medical Products Administration
Category
Quality
Risk
Low
Due Date
2025-02-11
Status
In Progress
Owner
Tomoko Ikeda
Created
2024-01-25
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0064, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.