If the new product passes GLP regulatory requirements, it can proceed to the next stage of development. Once a new product passes the tests for being safe and effective, the FDA will allow it to be produced. There are GMP regulations which govern how a drug, device, or biologic that is going to be used by humans must be manufactured. The main function and purpose of these regulations is to ensure that there are no mix-ups or mistakes and that only high quality, safe, and effective products reach the marketplace. The baseball diamond represents new product development.
Home plate is a safe and effective product.
The FDA will umpire. Let's sort it out. First base in the development of a new drug, medical device, or biologic is discovery and safety. The GLPs are the regulations that apply at this stage. These regulations provide specific requirements and documentation for a new non-clinical laboratory study.