cGMPs: current Good Manufacturing Practices

 

cGMPs have become the gold standard for quality and safety for all healthcare products and their packaging at every step in the supply chain.
 
That’s why DISC has made cGMP compliance a priority and an integral part of our Quality Management System.  We hold ourselves – and every team member – accountable for always doing the job right.
 
Just what are cGMPs?  Simply put, they are the rules of the game.  
 
The U.S. Food & Drug Administration has set the bar high when it comes to regulating all aspects of the manufacturing process for pharmaceuticals.  The 21 Code of Regulations, Parts 210 and 211, defines the parameters, stating that “the manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products.”
 
Integrity, accountability, batch control, track-ability, consistency…are all at the core of cGMP compliance.  Packaging and labeling components for pharmaceuticals, nutraceuticals and other healthcare categories, as well as food products, must be continually monitored throughout the manufacturing process, straight through to the clients’ delivery points.
 
The system of compensating controls within our cGMP program was developed to virtually eliminate the risk of cross-contamination.  Highlights include:
 
  • Glue line scanners that read bar codes printed on the inside glue flap
  • Count reconciliation at the beginning and end of each process
  • Pallet identification throughout the manufacturing cycle
  • Glue line segregation and identification to assure proper carton labeling
  • And of course, waste control, sanitation, maintenance and pest control