Things to consider when choosing GMP Manufacturing Facility
Here is a list of recommended things you need to do before choosing any facility to manufacture your product.
- Check to see if the manufacturer is registered with the Food and Drug Administration (FDA). It is one of the simplest things to do and an important factor you shouldn’t overlook
- Another factor to consider is to know if the facility has been approved by the FDA, more importantly within the last two years. GMP manufacturing facility needs to be FDA approved, thus showing that they have a facility that meets the standards of the current GMP (cGMP). Their inspectors will carry out a full systems-based cGMP inspection on that facility.
- You should also know about the FDA ratings on the facility? As soon as the inspection is completed, the FDA inspectors will rate the facility.
If you’re looking for a GMP manufacturing facility to produce generic products for sale in the US, you need to make sure that the facility has all the amenities you need. Also check to see if the facility is paying their GDUFA (Generic Drug User Fee Act). This compulsory fee is paid to ensure the facility has the go ahead to manufacture generic products for the US marketplace.
You also need to make sure that the GMP Manufacturing facility has a drug establishment license that identifies the facility and all the activities performed in the country. Some of the activities include manufacturing, packaging, labeling, testing, distribution, and wholesaling