by Dr. Yashashwini Reddy | Jul 19, 2024
Like we see defects in tablet compression, tablet coating is also associated with some defects. In this article, we will see the defects that are possible for coated tablets during the manufacturing process and most of the defects are due to the low technical skills...
by Dr. Yashashwini Reddy | Jul 1, 2024
A product needs to be tested and proven for its quality and compliance requirements before it reaches the factory to the consumer. With the increasing complexity of the equipment being manufactured as per consumer demand, there is a chance for countless errors. So,...
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 | 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...
by Dr. Yashashwini Reddy | May 30, 2024
SOP ON ROLES AND RESPONSIBILITIES OF QA DEPARTMENT 1.0 Objective: To outline the roles and responsibilities of the quality assurance department 2.0 Scope: This SOP shall be applicable to Personnel working in quality assurance and activities of QA department. 3.0...
