What do the regulations under cGMP focus on?

The regulations under current Good Manufacturing Practices (cGMP) focus on the appropriate design, monitoring, and control of manufacturing processes. These regulations are established to ensure that products are consistently produced and controlled according to quality standards. cGMP emphasizes the importance of a systematic approach to manufacturing processes that includes quality assurance and quality control, ensuring that products are safe, effective, and of high quality for consumer use.

By focusing on the design of the manufacturing processes, cGMP ensures that facilities are appropriately built and maintained to minimize risks of contamination or errors. Monitoring involves regular checks and tests to ensure that processes are being followed correctly, while control measures are in place to ensure that any variability in processes is addressed promptly.

This focus on manufacturing processes is crucial in sectors like pharmaceuticals, biotechnology, and food production, where public health and safety are of paramount importance.