What are Good Manufacturing Practices (GMP) and why are they important? GMP refers to a set of guidelines and regulations aimed at ensuring the quality and safety of products throughout the manufacturing process. They are important as they help maintain product consistency, minimize risks, and protect consumer health. How do GMP regulations differ from industry…
What are the 4 types of validation? A) Prospective validation B) Retrospective validation C) Concurrent validation D) Revalidation How many stages for process validation life cycle? Process Design: Process design is the first stage of the process validation life cycle approach. Design the manufacturing process of the subject product based on the knowledge gained…
1. What is Sterilization? The process which destroys all the forms of microbial life including Fungus,Viruses & viable cells of micro-organisms along with their spores by using Chemical as well as Physical methods is called sterilization. There are major 2 methods of sterilizationas: 1. Physical method a) Heating Dry heat sterilization:160°C-180°C for 1.5hrs For…
What is In process checks? In process checks are checks performed during an activity,In order to monitor and,if necessary, to adjust the process to ensure that product confirms to its specification. What are the check point during line clearance of granulation area? Why granuation is important? To improve powder flow. To improve compressibility….
What is the Full form of HPLC? HPLC stands for High-performance Liquid Chromatography or High-Pressure Liquid Chromatography. What is the HPLC Principle? It is a chromatographic technic used to separate the components from a mixture of a solution by using a solid stationary phase and a liquid mobile phase. How many types of…
Most relevant interview questions for freshers and experienced candidate applying for Regulatory Affairs positions in the US market, specifically in the context of generic submission (ANDAs): For Freshers 1. Can you explain what an ANDA is and its significance in the generic drug approval process? 2. How do you envision your role as…
