Three Steps to Prepare for an FDA InspectionJillian Yang
What is an FDA Inspection?
Whether you manufacture, handle, transport, or store drugs, there are a host of quality and regulatory requirements which must be followed to ensure you are in federal and state compliance. One of the governing entities you are certain to interact with at some point is the Food and Drug Administration (FDA)
According to FDA’s website, “The FDA conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act.”
This means that any organization that is regulated by the FDA is subject to a potential inspection including vaccine and drug manufacturers, blood banks, compounding pharmacies, and clinical trial sites that conduct studies on people, among many others. There are four types of FDA inspections:
- Pre-approval inspections (PAI): The FDA will conduct a PAI after a company submits an application to market a new product to assure that any manufacturing establishment named in the drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.
- Routine inspections: These are regularly scheduled routine inspections of any FDA-regulated facility. These can take place at any time and can be either announced or unannounced.
- Compliance follow-up inspections: According to Pharmaceutical Online, these take place if an organization is issued significant violations during a previous inspection. The FDA will then conduct a compliance follow-up inspection to ensure the organization has “responded adequately and corrected any previous violations.”
- For-cause inspections: This is the most concerning type of inspection because it occurs in response to a specific problem or issue that has come to the FDA’s attention. These may be issues reported from either consumers or employees.
Once an inspection is completed, the FDA will issue a Form 483 or “inspection observation” to outline any conditions the investigator has observed that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In FY 2021, the FDA issued 215 FDA 483s in the area of “Drugs” according to ECA Academy.
Undergoing an FDA inspection can be incredibly stressful so it’s important to ensure your organization is prepared for the inspection before it happens. Because these typically involve an investigator visiting your facility, being prepared will prevent you from scrambling once the inspectors are on-site. Inspections can last anywhere from a couple of hours to a week or more depending on the scope of the inspection and the size of the organization.
This article will outline three key steps your organization can take to ensure you are always ready and prepared for an FDA inspection at any time:
Put Quality and Regulatory First
The saying that ‘quality and regulatory isn’t a problem until it is’ certainly rings true when it’s time for an FDA inspection. But the truth is that no organization has ever failed an inspection because they chose to over-prioritize quality and regulatory from the get-go.
This is because putting quality and regulatory first is a market differentiator that not only ensures that your organization can achieve and maintain accreditations, but will also save you time, money, and headaches down the road. Diligence in this area plays a critical role to protect your customers, employees, vendors, and the character of your business. This is a small investment to ensure your organization’s success both in the short and long term.
Have (And Follow) Established Policies and Procedures
Standard Operating Procedures (SOPs) exist for a reason. Not only will they help to ensure your organization is responding to regulatory and/or business changes in a timely and consistent manner, but they also provide a clear roadmap, establish responsibilities, capture documentation, and ensure successful outcomes. In fact, the FDA issued observations for “Procedures not in writing, nor fully followed” to 17% of the drug manufacturing sites it inspected in 2021.
The regulatory environment is constantly changing so it’s important to stay nimble and responsive to everything coming down the pipeline. Having established SOPs in place will also allow you to document and manage these changes across the organization. To that end, it will also make things much easier to package and hand the necessary documents over to the inspectors once they arrive.
To that end, having a robust Quality Management System (QMS) to include things such as supplier qualifications, internal audits, and documentation of evidence-based decision making will also support a more streamlined inspection.
Infuse a Culture of Compliance Across the Entire Organization
FDA inspections should not fall solely on the Quality team. Regulatory compliance is the responsibility of every member of the organization, including the executive leadership team, so cross-functional collaboration is vital for ensuring an FDA inspection goes as smoothly as possible.
If management has not bought into the importance of compliance, then neither will your employees. The attitude of management establishes priority for the entire organization, which in turn drives resources and participation. Compliance should- and must- be incorporated into the culture of an organization.
Startups and emerging drug manufacturers have a tremendous opportunity to do this early on in a way that can also scale with the organization as it grows. For example, business units must partner with the Quality team to look for opportunities to continually improve their processes both before and after the inspection so ensuring there is connectivity between these teams is also key. Establishing transparency between these different units and functions is vital for reporting deviations, non-conformances, and complaints to the Quality team.
While taking these three steps won’t guarantee that your organization passes an FDA inspection, it will help to ensure you are prepared and ready for when an inspection does occur. These will also allow your organization to stay “audit ready” for whenever the next inspection comes around.
- Place quality and regulatory at the center of everything you do before it becomes a problem
- Policies and procedures are there to protect you so establishing and following them will save much heartache down the road
- Compliance is the responsibility of every team member so infusing it across your company culture ensures you are always ready
QRCare is a quality and regulatory consultancy service that provides organizations with the support needed to develop and maintain strategic quality and regulatory efforts. Whether they are establishing a system from the ground up, preparing for a supply chain inspection or implementing change control, QRCare offers assistance to customers throughout their quality and regulatory journeys. For more information about partnering with QRCare, please visit here.