The expanding global footprint of pharmaceutical manufacturers brings about great opportunities, but it's not without the challenges faced by pharma companies in drug development. Compliance hurdles in emerging markets are causing a stir. The United States Food and Drug Administration (US FDA) has published many warning letters of significant FDA violations by manufacturers under their jurisdiction. Lack of lab controls (13%) and non-adherence to procedures (21%) are among the top compliance issues cited by the FDA.
Audits and adherence to dynamic regulations have posed serious challenges for various pharmaceutical organizations. To list down the forthcomings of pharma audits, FDA warning letters and compliance adherence letters are endpoints, thereafter the compliance bridging is in the hands of pharmaceutical companies. Amongst such compliance letters, Form 483 issued by the US FDA remains frightening for any pharmaceutical establishment.
Between 10/1/2015 and 9/30/2016, the United States Food and Drug Administration (USFDA) through its system has issued almost 3905 483s to Biologics (84), Medical Devices (934), Drugs (691), and Food (2196) manufacturers. The number shows that there is significant rise in manufacturing violations when the health agency inspected respective facilities. Instances of companies failing to adhere to cGMP (current Good Manufacturing Practice) were observed followed by receiving FDA warning letters, facility shut down, and severe cost burdens to manufacturers.