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Choosing a GMP Manufacturing Facility

11:14 PM Dhanur Chauhan 0 Comments

The acronym GMP certified manufacturer stands for Good Manufacturing Practices. However to be GMP certified implies that the manufacturer has met the requirement and standards of the international GMP. Most companies out there are looking for a reliable GMP Manufacturing facility with all the amenities in place to manufacture a particular product. You search ends here. Cedar Brook is the leading office and Science Life campus in New Jersey offering world class GMP manufacturing facility.

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.
Pharmaceutical quality affects every American. FDA is saddled with the responsibility of regulating the quality of pharmaceuticals with utmost care. The Current Good Manufacturing Practice is the main regulatory standard for ensuring pharmaceutical quality. Each batch of medicines taken by consumers is expected to meet the quality standards, thus guaranteeing safety and effectiveness. Most people, however, are ignorant of the Current Good Manufacturing Practice or how FDA assures that drug manufacturing processes meet these basic objectives.

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

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