by Dr. Yashashwini Reddy | Jul 20, 2024
Cleaning Validation in Manufacturing: Ensuring Effective Procedures Cleaning validation is done to measure the effectiveness of cleaning procedures in removing residues from previous products. After the execution of a batch, the equipment must be cleaned according to...
by Dr. Yashashwini Reddy | Jun 25, 2024
An abbreviated new drug application is submitted to the FDA Office of Generic Drugs. let us learn about generic drug products before the ANDA application Process. A Generic drug product is comparable to the innovator in terms of strength, dosage form, route of...
by Dr. Yashashwini Reddy | Jun 25, 2024
While learning regulatory affairs there are several abbreviations you come across, you usually end up searching for them. Here is a list of abbreviations that are commonly repeated. There are several topics related to regulatory affairs where you come across these...
by Dr. Yashashwini Reddy | Jun 15, 2024
In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc. Regulatory pathways for New Chemical entities: Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA...
by Dr. Yashashwini Reddy | Jun 4, 2024
Standard Operating Procedure for operation and cleaning of Tray Dryer Objective: To lay down the standard operating procedure for the operation and cleaning of tray dryers used in pharmaceutical manufacturing Scope: This SOP applies to the personnel involved in the...
