Deficiency letter: missing stability data for 40°C condition
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0073. Type: question. Risk: medium. Category: Quality.
Correspondence ID
COR-273
Type
question
Application
Authority
Central Drugs Standard Control Organisation
Category
Quality
Risk
Medium
Due Date
2025-01-10
Status
Open
Owner
Aisha Okonkwo
Created
2023-04-22
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0073, 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_273.xlsxattachment_273_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.