by Dr. Yashashwini Reddy | May 6, 2025
Pharmaceutical labeling requirements typically include specific guidelines to ensure proper communication of key product information, safety, and usage details. Pharmaceutical labeling requirements are critical to ensuring the safe and effective use of medications....
by Dr. Yashashwini Reddy | Apr 13, 2025
The implementation of pharmaceutical isolators in manufacturing is regulated by the Current Good Manufacturing Practices (CGMP) established by the FDA and the EU GMP guidelines, both of which are designed to ensure the quality and safety of pharmaceutical products....
by Dr. Yashashwini Reddy | Oct 24, 2024
Good Laboratory Practices (GLP) in the pharmaceutical industry are a set of internationally recognized standards that ensure the quality, consistency, and integrity of non-clinical studies. These practices are critical for ensuring that the data generated during drug...
by Dr. Yashashwini Reddy | Sep 22, 2024
Understanding Data Integrity and Its Importance in Pharmaceuticals In the pharmaceutical industry, data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. It ensures that data, whether recorded electronically or manually,...
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...
