By Yves Massicotte, President, Ropack Pharma Solutions
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records and conducting audits more frequently – up from .06 to .09 per year, according to Bloomberg News.
Even the most compliant may feel vulnerable. However, understanding the process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.