GMP inspection findings clarification
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0053. Type: commitment-request. Risk: low. Category: Quality.
Correspondence ID
COR-253
Type
commitment-request
Application
Authority
Central Drugs Standard Control Organisation
Category
Quality
Risk
Low
Due Date
2025-04-12
Status
In Progress
Owner
Marcus Webb
Created
2022-10-13
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0053, 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
data_table_253.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.