The ultimate goal of the U.S. Food and Drug Administration is to protect the public welfare and protect consumers from unsafe products. Regulatory investigators are responsible for enforcing compliance to regulations. This enforcement is accomplished through on-site inspections designed to observe and evaluate a firm’s compliance with regulatory requirements.
If your firm manufactures FDA regulated products, you can expect periodic inspection visits. The nature of the inspection may vary:
The scope of inspection may encompass a comprehensive evaluation of the facility and the facility’s procedures to confirm conformance with regulations. The inspection may be system-based or limited to a specific issue/area.
FDA Inspectors have broad authority with regard to conducting an inspection. They may enter the workplace anytime during business hours (presenting the firm with a FDA Form 482), speak with employees and management, and observe the operation of processes, instruments, and/or equipment. Additionally, they can require the firm to provide documents (and may retain copies), take photographs, collect samples (authorized by FDA Form 484), review historical electronic data, and inspect the contents of trash and recycling bins.
Q: Why has the FDA been granted this broad power?
A: Because GMP regulations are intended to ensure that human and animal products are safe and effective and otherwise in compliance with the federal, Food, Drug and Cosmetic Act (the Act). The Act was established to ensure Quality, Safety, Identity, Purity, and Strength of marketed food and drugs. FDA inspections are the government’s way of assuring the public that food and drugs comply with 21 CFR 210/211 GMP requirements. In support of that, FDA must assure accuracy and completeness of reported results, review evidence that procedures are followed, and ensure that your firm is in an overall state of control.
Anticipating an FDA inspection may seem intimidating, here are some tips on how you can ready your site:
Understanding you firm’s quality system limitations and having a developed plan to improve will help ensure that you are prepared for your next regulatory inspection.
Stay tuned, Part II of this blog series discusses what to expect during an FDA inspection.