Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
Information
Type
International scientific guidelines adopted in Australia
Regulated products
Medical Devices
Topics
Biological Medicines, Listed Medicines, Prescription Medicines
Published
July 18, 2024
Last updated
July 18, 2024
Description
We have adopted this International Scientific Guideline - EMA/CHMP/BWP/187338/2014
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)