The United States Food and Drug Administration (US FDA) recently completed a current Good Manufactur-ing Practices (cGMP) inspection of the NEW GPC INC. facility located on the East Bank of Demerara which extended its clearance to export pharmaceuticals to the US.
A release from NEW GPC on Saturday said that the inspection occurred from September 1 to September 4, 2014. The release said that NEW GPC INC. currently exports Over-the-Counter (OTC) drug products and Dietary Supplements to the United States.
The US FDA periodically inspects foreign companies that export to the United States to assure compliance with the Code of Federal Regulations (CFR) Title 21, Parts 111, 210 and 211, the release said.
The recent inspection of the NEW GPC INC. facility, the release said, encompassed 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.”
Further, it said that various systems established to drive continuous improvement were examined such as training, complaint handling, and changes related to products and systems.
In an effort towards continuous improvement, the NEW GPC release said that 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 will be used to test incoming components, raw materials and finished drug products conforming to the British Pharmacopeia and the United States Pharmaco-peia. NEW GPC INC. said it is committed to making future capital investments in its manufacturing and inspection facilities to maintain compliance.
