The United States and European Union both attempt to control the safe testing and manufacture of medical devices and pharmaceutical products through Good Manufacturing Practices or GMPs. In general, these practices adhere to two primary ideas:
- Manufacturing processes should be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications that the manufacturer has developed for the product.
- Manufacturing processes are controlled, and any changes to the process are evaluated before they are changed. Changes that have an impact on the quality of the product (the drug, or medical device) are carefully evaluated.
However, these GMPs are not nearly as helpful or as straightforward as they seem.