GMP inspection findings clarification
Correspondence from National Medical Products Administration regarding NMPA-2021-0084. Type: query. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-584
Type
query
Application
Authority
National Medical Products Administration
Category
Nonclinical
Risk
Medium
Due Date
2024-12-23
Status
Open
Owner
Carlos Mendez
Created
2023-05-05
Correspondence Body
Dear NMPA Review Team,
With reference to application NMPA-2021-0084, 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
data_table_584.xlsx
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.