GMP Auditing

Performing self-inspections is critical to ensuring that quality systems remain effective and operating in a state of compliance. Objective self-inspections are key to providing senior management and the Board of public companies assurance that compliance issues, concerns, or gaps are pro-actively identified in a timely manner and then corrected or mitigated to reduce compliance risks during actual regulatory inspections. Third party consulting firms such as JYA provide the "objectivity" that is needed to properly ensure that the benefit of having "outside eyes" evaluate existing quality systems is realized on a routine basis particularly when it comes to auditing Quality Assurance and/or Regulatory Compliance Departments.

It is important to emphasize that companies must develop thorough and in-depth auditing processes and procedures to provide senior management confidence that operations remain not only lean and pragmatic, but also that operations continue to operate in an adequate state of compliance and in adherence with current good manufacturing practices (cGMP) regulations. It is not FDA or any other regulatory agency's responsibility to "regulate or inspect" a company into compliance. All too often companies attempt to incorrectly utilize a "check the box" mentality or approach to compliance. As a former FDA investigator, I can only state that it is more important for companies to identify their own problems and deficiencies and take pro-active measures or actions rather than simply waiting to be cited for the same problems or deficiencies by the FDA.