If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual? FDA audits can be stressful, and failing one can have significant consequences. With proper preparation, however, the call to schedule an FDA inspection doesn’t have to be so unnerving.
There are different types of FDA inspections, including:
If you receive the phone call from the FDA scheduling a routine inspection, it’s important to immediately view the looming inspection as an all-hands-on-deck opportunity. “That moment in time is a real opportunity for a reality check – for really determining what your current state is, what you need to do and what you can do in the time you have before the FDA will arrive,” according to Linda Chatwin, who heads the Medical Devices Regulatory Services section of UL in North America.
Inspection preparations can be grueling. Following the FDA Quality System Inspection Technique (QSIT), the inspector assesses an organization’s systems, methods and procedures to ensure a quality management system (QMS) is established and maintained effectively. The FDA inspection process typically involves observing employee activities, interviewing employees, reviewing records and looking at documented procedures and requirements to assess how they all fit together in the quality system.
In some cases, even two weeks is not enough time for companies to prepare for a routine inspection. And in the case of a for-cause audit, the lack of advanced notice can be particularly stressful. Rather than scramble to prepare everything and everyone when the FDA comes calling, it’s better to maintain a constant state of readiness before that phone call even occurs.
“The best way to survive an FDA inspection is to always be prepared for it,” according to Chatwin, who offered some insight into FDA audit readiness in a webinar with compliance and risk consultant Walt Murray.
Any company in the life sciences should have an FDA policy and procedure in place. As part of an organization’s audit plan, there should be an FDA audit checklist, appropriate teams should be identified, and team members should understand their roles and responsibilities relating to inspections. Site personnel should be aware of – and even trained in – FDA inspection procedures, which items to have ready during an inspection and how to interact with the FDA investigator. To reinforce its commitment to the policy, company leadership should ensure that employees receive ongoing training on the policy and procedures.
(Remote audits require more planning and preparation. For guidance on participating in remote audits, see "Conducting Audits at a Social Distance" and "Remote Audits Reignite Regulated Companies and Supply Chains.")
In the webinar, Chatwin and Murray highlighted three tools that can help organizations maintain a constant state of audit readiness:
These three types of audits can provide insight into areas where operations can be improved. However, because an audit is a sampling of activities at a point in time, it’s difficult, if not impossible, to examine every single process, practice and procedure during any given audit. Even if you have external or mock audits, it is important to monitor and review internal audit results for previously unaddressed problems.
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