Information request: extractables and leachables data
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0068. Type: deficiency. Risk: medium. Category: Quality.
Correspondence ID
COR-068
Type
deficiency
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Quality
Risk
Medium
Due Date
2024-12-23
Status
Open
Owner
Aisha Okonkwo
Created
2022-08-19
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0068, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
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: 2024-12-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.