Pharma Product Design, Technology & Commercial Manufacturing

About this course

This course will take you to understand about how product is designed, product transfer & validation aspects before commercialisation. After commercialisation further it will focus on how stability study is performed.First of all, we need to learn about product development as per the ICH guideline - ICH Q8. This will explain us about how to design the pharmaceutical products and also how quality by design concept to be followed. After this, main step is about technology transfer in the pharmaceuticals. This technology transfer will focus on transfer of analytial technology as well as manufacturing process technology in the manufacturing unit. Once technology is transferred, the first commerical batches manufactured should be studied in detailed as per the process validation requirements. Furthermore, it is important to note that, there is special care to be taken in case of manufacturing of potent molecules. So, a separate lecture on manufacturing of potent molecules is available in this course. This is still not enough for pharmaceutical products. After process validation, the process validation batches should be subjected for stability study. Furthermore, long term stability study will be continuted for every year. Overall this training session will be very much helpful for all pharmaceutical professionals for learning from design the product to commercialisation.

Course objectives

• Provide an overview of the pharmaceutical product design process
• Explain the importance of validation before commercialization
• Highlight methods for conducting stability studies over time
• Discuss the unique challenges associated with potent molecule manufacturing