Information request: manufacturing process change justificat
Correspondence from ANMAT regarding ANMAT-2020-0075. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-075
Type
question
Application
Authority
ANMAT
Category
Nonclinical
Risk
Medium
Due Date
2025-04-07
Status
Completed
Owner
Lieselotte van der Berg
Created
2023-01-03
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0075, 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_75.xlsx
Response Package
Response package assembled: RP-075