Types of cGMP
U.S. FDA has categorized cGMP into four different types and stablished management standards for each one of them. You can access to the original data sources through below links.
Medical devices cGMP
Among these, the one for cosmetics is still a draft version. The draft is not much different from the ISO 22716
In fact, other GMP regulations are not significantly differ from the corresponding international standards. However,
inspectors from U.S. FDA goes into the most details;
check whether the person in charge for a specific job is aware of the requirements, and;
compare the process of the site with the established procedures and standards.
To be prepared for the inspection from U.S. FDA, you have to thoroughly read the regulation and look back into your systems whether you are in compliances with them, a word by a word.
Wise Co., Inc. has experience of preparing for and responding for the inspections.
Please Contact us for any further question.