THE United States Food and Drug Administration (US FDA) recently completed a comprehensive current Good Manufacturing Practices (cGMP) inspection of the New GPC Inc. facility located on the East Bank of Demerara, Guyana. 

The inspection occurred from September 1 to September 4, 2014. New GPC Inc., in a statement over the weekend, said it currently exports Over-the-Counter (OTC) drug products and Dietary Supplements to the United States market. The inspection culminated in continued clearance for the company to export its products to the United States.

The US FDA periodically inspects foreign companies that export products to the United States to assure compliance to the Code of Federal Regulations (CFR) Title 21, Parts 111, 210 and 211. Compliance to these regulations is essential in assuring that only safe and effective products are manufactured and exported to the United States.
The recent inspection of the New GPC Inc facility covered many areas which may have included procedures for procurement, inspection, testing and approval of materials, requirements for manufacturing equipment, product specifications, warehousing, storage conditions, stability of products, and management of product traceability after distribution or sale. Additionally, various systems established to drive continuous improvement were examined such as training, complaint handling, and changes related to products and systems.

The final inspection report supported and validated New GPC Inc’s compliance and commitment to US regulatory standards, assuring safety to all users of its products. In an effort towards continuous improvement and excellence, the company is focused on expanding the Quality Assurance and Quality Control Departments by investing in state-of-the-art testing equipment. The new instrumentation is and will be used to test incoming components, raw materials and finished drug products conforming to the British Pharmacopeia and the United States Pharmacopeia.
The Company said it is proud to meet or exceed the requirements of all of its international importers, in the United States, as well as other global markets. With global standards becoming increasingly rigid, New GPC Inc. said it is committed to making future capital investments in its manufacturing and inspection facilities to maintain compliance.
The New GPC Inc. Board of Directors thanks the management team and staff for maintaining the high standards necessary to be considered a world class facility. New GPC Inc. would also like to thank its loyal customers for their continued support.