Current Good Manufacturing Practice (CGMP)
Current Good Manufacturing Practice (CGMP) refers to the regulations enforced by the FDA to ensure that products are consistently produced and controlled according to quality standards. In the context of manufacturing, especially within industries like pharmaceuticals and food production, CGMP guidelines are crucial for maintaining product safety and efficacy. These practices involve rigorous processes, including proper equipment maintenance, employee training, and thorough documentation. For example, a pharmaceutical company must adhere to CGMP to ensure that its medications are free from contamination and correctly labeled. While CGMP ensures high-quality production, it can also present challenges, such as the need for continuous updates to comply with evolving regulations. Understanding CGMP is crucial for leveraging Industry 4.0 technologies to enhance compliance and efficiency.