Information request: manufacturing process change justificat

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0038. Type: query. Risk: medium. Category: Quality.

Correspondence ID
COR-438
Type
query
Application
SAHPRA-2022-0038
Authority
South African Health Products Regulatory Authority
Category
Quality
Risk
Medium
Due Date
2025-04-14
Status
In Progress
Owner
Carlos Mendez
Created
2022-06-13
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0038, 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_438.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.