• Ruchita Negi
• Meenu Chaudhary
• Taniya Dimri

Quality plays a crucial role in the growth of every organization and it is the key element that aids in attaining customer satisfaction. In terms of pharmaceutical industry quality is assured and inevitable factor as the pharmaceutical product formed are directly or indirectly delivered to customers body so it is essential that the product should be pure, safe and fit for use. To regulate various aspect of quality ICH (International Conference on Harmonization) has defined an ICH Q series where Q9 guideline enlists various tools that can be used for managing risk to the quality of pharmaceutical product and Q10 guideline which is a Pharmaceutical Quality system model. ISO 9001 also contributes in management of quality by setting various standard to meet quality expectation of the customer. Managing quality in pharmaceuticals can be tricky and time-consuming job if done manually so to make it less complex various QMS software’s have been developed and are being used by various industries for monitoring and managing quality at every step of products lifecycle. This paper focuses on various dimensions of quality and its management, Total Quality Management (TQM), Software used in QMS and guidelines for quality management- ICH Q-series (with emphasis on Q9 and Q10) and ISO 9000:2015(Quality Management System)

Quality, QMS Software, ICH, ISO, Quality Risk Management, TQM

"A Comprehensive Review on Pharmaceutical Quality Management", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 4, page no.o373-o387, April-2024, Available :http://www.jetir.org/papers/JETIR2404F54.pdf

"A Comprehensive Review on Pharmaceutical Quality Management", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 4, page no. ppo373-o387, April-2024, Available at : http://www.jetir.org/papers/JETIR2404F54.pdf