Information request: manufacturing process change justificat

Correspondence from National Medical Products Administration regarding NMPA-2021-0084. Type: deficiency. Risk: high. Category: Quality.

Correspondence ID
COR-084
Type
deficiency
Application
NMPA-2021-0084
Authority
National Medical Products Administration
Category
Quality
Risk
High
Due Date
2025-05-06
Status
In Progress
Owner
James O'Brien
Created
2023-03-02
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0084, 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_84.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-05-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.