by Dr. Yashashwini Reddy | Nov 21, 2024
Parts of Analytical Validation in the Pharmaceutical Industry Analytical validation plays a crucial role in ensuring that pharmaceutical products meet the highest standards of quality, safety, and effectiveness. It confirms that the methods used to analyze these...
by Dr. Yashashwini Reddy | Sep 16, 2024
Residual solvents are volatile organic chemicals that remain in pharmaceutical products even after the completion of the manufacturing process. These solvents are often used in the production of active pharmaceutical ingredients (APIs), excipients, or the final drug...
by Dr. Yashashwini Reddy | Sep 2, 2024
Stability Testing in Pharma Stability studies are one of the essential and crucial aspects of pharmaceutical development. It is a very important aspect of the drug product or drug substance manufacturers. Stability testing or studies are done to examine the influence...
by Dr. Yashashwini Reddy | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
