Query: container closure integrity study methodology

Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0053. Type: question. Risk: medium. Category: Nonclinical.

Correspondence ID
COR-353
Type
question
Application
CDSCO-2022-0053
Authority
Central Drugs Standard Control Organisation
Category
Nonclinical
Risk
Medium
Due Date
2025-01-22
Status
Overdue
Owner
Lieselotte van der Berg
Created
2023-04-13
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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.