ABSTRACT
Validation is defined as assortment and estimation of data from the process design stage through marketable production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Validation is documented evidence in scale-up and technology transfer for the development of pharmaceutical products. Robust and reliable manufacturing processes are essential to maintain the quality of pharmaceutical products. Product development is critical, starting from lab development, validation, scale-up and technology transfer to commercial production. Hence, in this chapter, we discuss and elaborate validation, i.e. method validation, filter validation, scale-up challenges and successful technology transfer in pharmaceutical product development as per regulatory requirements.
