All companies talk about conducting successful inspections but how many have clearly defined what a successful inspection is? In this blog, I will talk about what I feel are key attributes in order for a company to deem their inspections a success.
First and foremost, a successful inspection must allow you to obtain or maintain your right to manufacture and distribute a product. Whether this is your first pre-approval inspection or a general GMP inspection, there are significant consequences for failing to get approval or to be found “out of a state of control.” The inability to sell and market products caused by a failed PAI GMP inspection, affects not only your bottom line but the patients that need your products.
The second priority for a successful inspection is to avoid less severe but still damaging regulatory or market actions, which include product withdrawals, product recalls, warning letters and even seizures. While not as severe as losing the right to operate, these actions still affect the company financially by potentially causing a loss of revenue, a loss of market share, and a loss of stock value while also damaging your company’s reputation and opening the possibility for litigation.
The above two priorities are critical to the success of the company. However, there are other, less critical but still important, goals for managing inspections.
Minimize the number and scope of the findings: I believe that many companies err in making this a critical outcome for an inspection to be considered successful. While this goal is certainly important, it is more important in my mind to look at the bigger picture. While you definitely want to minimize the number, scope and significance of findings, in some instances, it might be better to accept a finding rather than to continuing to “discuss” the issue during the inspection. Inspectors are human, too, and if they feel you are arguing without merit (and if the goal is zero observations, this can occur), the tone of the inspection can be negatively impacted harming your ability to influence the outcome of a more significant issue later in the inspection.
Maintain the confidence of the health authorities: You can damage your image with health authorities by the way you handle an inspection. Regardless of the outcome of the inspection, you need the health authorities to perceive you as being open and cooperative rather than closed and secretive. You need the health authorities to feel your company is committed to quality and doing “the right thing.”
Have few or no surprises during an inspection: If you have implemented a robust inspection management system that includes regular updates to Senior Management, no one should be surprised by the inspection findings and outcome. However, if there are surprises, it is important to review and assess your inspection management system to understand where there are still gaps and improve the system to try and ensure there is no recurrence.
Maintain good inspection logistics: By implementing a robust inspection management system, there should be good communication between the inspection room and preparation rooms. Documents should flow smoothly and as requested after being appropriately vetted; presenters should be well-trained and informed of the current issue under discussion before interacting with the inspectors; and the right people should be available at the right time with the right information. If you do this really well, you can minimize the effect of the inspection on your site’s operations.
By defining what a successful inspection is for your company, you can ensure everyone is working together to meet those goals, which in turn, will increase the probability of having a successful inspection outcome. At Enterey, in partnership with Mark Tucker, LLC, we can help you in all aspects of inspection management to help ensure you meet your inspection outcome goals.
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Published by Mark Tucker | Inspection Management & Auditing Expert, Enterey and Mark Tucker, LLC
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