Current Good Manufacturing Practices (cGMP) are systems in place that ensure that a product is being made according to current regulations. This means that it meets quality standards, production standards, and regulatory standards. While working in quality engineering at Zimmer-Biomet, 21 CFR Part 820 of the QSR was the bible in our department. I agree with all of the parts listed in the task and they provide a good overview of the requirements as listed in the book. cGMP’s are important in any step of the manufacturing process, whether its the initiation, planning, execution, closing, or monitoring phase. In the initiating and planning phase, the goal is to essentially come up with a procedure to, lets say, create a new product. A regulatory system is essential at this step because it lays out all of the regulatory requirements needed to even begin the project. In the Executing phase (manufacturing step), a product must be traceable to ensure proper creation, and to limit scrap and co-mingling of parts during the manufacturing of the product. In the monitoring and controlling phase, a quality system and security measures are essential to assess any issues with the process and ensure the proper nonconformance/CAPA process is followed to troubleshoot any errors and get they system back on track. Lastly in the closing phase, again, a quality system is necessary to provide proper assistance to any issues that arise post-production and once the product is out in the market.