Query: container closure integrity study methodology

Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0090. Type: query. Risk: medium. Category: Nonclinical.

Correspondence ID
COR-390
Type
query
Application
MFDS-2020-0090
Authority
Ministry of Food and Drug Safety
Category
Nonclinical
Risk
Medium
Due Date
2025-01-01
Status
In Progress
Owner
Priya Sharma
Created
2024-02-27
Correspondence Body
Dear MFDS Review Team, With reference to application MFDS-2020-0090, we wish to address the following: [Detailed response body regarding information request: extractables and leachables data] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_390_1.pdfdata_table_390.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.