I’m proud to share that my new book “Sterility Assurance Essentials” Volume 1- Fundamental and Regulatory expectation is now officially released! It is a practical guide for Beginners to Intermediate Professional. This book is the result of years of hands-on experience in the pharmaceutical industry, particularly in sterility assurance, contamination control, and aseptic processing. […]
Introduction This report presents a high-level assessment of the Form FDA 483 issued to Sun Pharmaceutical Industries Ltd., Halol, dated June 13, 2025, following a comprehensive inspection by the United States Food and Drug Administration (USFDA). The inspection revealed eight major observations related to deficiencies in aseptic practices, process validation, equipment maintenance, data integrity, and […]
1. Earning is the by-product of learning.
I always try to bring few important information or available information in a simplified way. After a long time I started work with Pen and paper and try to sketch and introduced few interesting topic.
Introduction The COVID-19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. Globally different support functions like API, excipient and packaging patterners to this industry are not able to respond with in pre-defined time frame. Apart from the third-party services like calibration and annual maintenance also impacted due to […]
Investing time for Planning and give best effort to execution, is the best way to get success. Ensure doing correct in first time only, don’t waste time in duplication. Here I will explain TIMWOOD, it a took to eliminate or reduce wastes. We know different explanation available for TIMWOOD, but I will emphasize on the […]
India always stand in the first row whenever there is a chance to serve for humanities and social welfare. Pharmaceutical sectors in India is one of the highest contributing segments, firms are not only generating revenue and also serving patients across the globe with high quality (safe, pure and efficacious) medicines. Pharmaceutical quality is […]
Remdesivir is an experimental drug from drug maker Gilead that has shown to bring down the viral load on patients and hence help in faster discharge. The efficacy of the drug on severe patients is still under study. The drug, intravenously administered in hospitals, has already been approved for emergency use in severely-ill patients in […]
Certainly, hydroxychloroquine is in the peak news. Because Mr. President of USA commented in his official Twitter as well as press release also. Other countries also started following the same and looking for the medicine hydroxychloroquine. But let’s see what WHO recommending for this medicine, “1WHO is actively following the ongoing clinical trials that are […]
One of the key advantages of using an isolator for an aseptic processing application is that it makes a physical barrier between the operator and the core aseptic processing area. Additional main benefit is that an isolator can be totally sealed before aseptic activity starts, allowing for the exposed interior surfaces within to be bio-decontaminated, […]
