by Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | May 17, 2024
In this article, we are going to learn the concept of process validation in concise . Validation is an act of proving right with documented evidence, suppose you create a new password, and the system to validate your password, asks you to re-enter so that you are...
by Naveen kumar | May 16, 2024
A Site Acceptance Test (SAT) is performed to know whether the system meets the required specifications and complies with the needs of the user. This on-site test is written, and executed by the client and involves thorough inspections and testing of system...
by Srikanth | Apr 21, 2024
What is IPQA (In-Process Quality Assurance) and why is it important in pharmaceutical manufacturing? This question assesses the candidate’s understanding of the role and significance of IPQA in ensuring product quality. Can you describe the key responsibilities...
