GMP inspection findings clarification
Correspondence from Health Sciences Authority regarding HSA-2023-0092. Type: query. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-492
Type
query
Application
Authority
Health Sciences Authority
Category
Nonclinical
Risk
Medium
Due Date
2025-04-28
Status
Overdue
Owner
Priya Sharma
Created
2023-09-08
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0092, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
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: 2025-04-28 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.