by Dr. Yashashwini Reddy | Oct 9, 2024
Selecting Die Size for Blend Uniformity Sampling in the Pharmaceutical Industry In pharmaceutical manufacturing, ensuring blend uniformity is critical for the quality and consistency of drug products. One key factor in achieving this is selecting the right die size...
by Dr. Yashashwini Reddy | Sep 20, 2024
In pharmaceutical manufacturing, blending plays a key role in ensuring that drugs are safe, effective, and of high quality. This process involves thoroughly mixing active pharmaceutical ingredients (APIs) with excipients (inactive ingredients) to ensure uniform...
by Dr. Yashashwini Reddy | Jun 4, 2024
Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...
by Dr. Yashashwini Reddy | May 17, 2024
In this article, we are going to learn the concept of process validation in concise . Validation is an act of proving right with documented evidence, suppose you create a new password, and the system to validate your password, asks you to re-enter so that you are...
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...
