According to ISPE, Good Manufacturing Regulations were created by the FDA to ensure that manufacturers take the proper steps to validate their products safety, purity and effectiveness. With these regulations the consumer is less at risk of receiving a product which is harmful or not effective. Since the GMP regulations are supported by law, the consequences of not abiding by them can be very serious. The cGMP regulations allows for more control of the PDCA cycle within project management. The planning phase/ planning processing group is where the thought process on which objectives are needed to reach the goal are determined. Being able to figure out from the beginning as to which regulations need to be followed to reach the end goal will help predict future development issues. Therefore, within the initiating processing group the steps on how to start the project can be modified to ensure that the final product abides by the cGMP regulations (regulatory). Executing Processing group is the development stages of the product. Within this stage traceability is vital because if a part has an issue then it can be traced back to its source and be fixed. I believe that the monitoring/ controlling processing group occurs throughout the entire PDCA cycle because everyone is always trying to figure errors in the device or plan in order to fix them before the deadline. Within this phase, the cGMP regulation of security will take effect. Lastly, the closing processing group is when quality regulations must be followed to make sure that the final product meets the quality assurance of the company.
Reference:
http://www.ispe.org/gmp-resources/what-is-gmp
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm