Information request: extractables and leachables data
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0099. Type: deficiency. Risk: medium. Category: Quality.
Correspondence ID
COR-399
Type
deficiency
Application
Authority
Ministry of Health of Russia
Category
Quality
Risk
Medium
Due Date
2025-01-06
Status
In Progress
Owner
Priya Sharma
Created
2023-01-21
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0099, 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
attachment_399_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.