By Peter Müller, Ph.D., CARBOGEN AMCIS AG
Routine inspections by the U.S. FDA are as important for non-U.S. pharmaceutical manufacturers as they are for U.S.-based companies. This is especially true for Swiss companies, which export a great share of their products to the United States. As a whole, Switzerland exports approximately 10 times more drugs and APIs than it consumes. For non-U.S. companies, which must undergo regular inspections by their native countries’ regulatory agencies, the FDA inspections provide extra validation that their products meet the highest effectiveness and safety standards and open the door to the U.S. market. An FDA inspection may seem intimidating, but it is a vital part of our business.
Always Be Prepared
Lead time before FDA inspections is typically very short, leaving little to no opportunity for preparations. Therefore, always being ready is essential to a successful inspection. A company should give consideration to the following priorities as it prepares for an inspection:
Be in control, from development to purchasing, producing, and shipping.
Have retrievable documents showing what you do, what you did in the past, and what you will do in the future. Document all processes and ensure that documents are accurate and readily available.
Communicate with your staff, suppliers, customers, and the authorities in charge, and document all communication.
In advance of the inspection date, assign qualified staff to work with the FDA inspectors and provide employees with the tools they need to get the job done.
Train all staff to interface with the FDA investigators.
Assess your quality risks in the broadest conceivable sense and from every possible angle, and take steps to mitigate the risks.
Be ready to learn from your experience and from the FDA inspectors, who have broad expertise.
Most importantly, never lose track of your main goal: protecting patients’ health and safety.
What FDA Inspectors Are Looking For
During the past 10 to 15 years, we have noticed a shift in how inspectors evaluate a company’s performance. They are increasingly moving away from checking specific details (e.g. calibration dates of balances, reanalysis dates of reference samples, or logbook entries on the cleaning of storage areas) and instead are focusing primarily on evaluating decision-making processes.
This shift underscores how important it is to ensure that all employees, regardless of their level within the company, embrace the commitment to patient health and safety. This commitment has now become the main quality differentiator among companies, and it goes well beyond checking the right boxes on a form.
Such commitment is particularly important for subcontractors that deal with a product mix of commercial APIs on the one hand, and development APIs in Phases 2 to 3 on the other hand, and that work with customers ranging from start-ups to the largest global players. The decision-making process has to be adapted to the respective development partnerships, asking project leaders to demonstrate not only scientific expertise but also a great amount of flexibility.
Regardless of differences in company size, the key principles remain the same for all types of customers and all levels of personnel: open and timely communication and science-driven, structured decision making. These are what inspectors are routinely checking for.
What To Do On Inspection Day
While doing homework is most important, there are things to keep in mind on inspection day:
Be hospitable. Consider that the inspectors are guests needing a conveniently located hotel, directions to your facility, the approximate distance and time it takes to travel there, special meal requests, etc.
Dedicate a team to manage the inspection on the day of the audit.
Instruct your staff to do their best to understand what the inspectors are looking for and encourage them to assist FDA inspectors.
Set up space for inspectors and assist with rapid copying, stamping, and delivering documents at the inspectors’ requests.
The most important thing a company can do to successfully pass an FDA inspection is to commit to quality every day, not just on inspection day.
Peter Müller, Ph.D., is senior scientific advisor, delegate of the Dishman board of directors, and member of CARBOGEN AMCIS AG’s management team.