by Dr. Yashashwini Reddy | May 5, 2024
Active Substance Master File also known as European Drug Master File allows the protection of confidential information regarding the ” know-how of the active substance manufacturer”. While protecting the intellectual property information ASMF equips the...
by Dr. Yashashwini Reddy | May 4, 2024
Whenever there is a need to address quality-related issues CAPA is initiated, examples of quality-related issues include deviations, non-conformances, market complaints, deficiency during internal audits, product recalls, etc. CAPA aims to address the issue in such a...
