As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, the supply chains from India and China are clearly critical in the manufacture of high-quality drugs. Even the Department of Defense recently announced that it will begin to conduct independent testing of imported generic drugs.

Whether you’re overseas or right here at home in the U.S., FDA regulatory oversight is rigorous, particularly after COVID19 now that the FDA has aggressively resumed on-the-ground inspections. The question you need to ask is, is your firm ready for the FDA, given the recent pressure put on the Agency? Most importantly, are you ready to deliver the high-quality medicines that patients need?

Here are some reasons to be proactive:

  1. Prepare for the real audit. Conducting a mock FDA inspection can help a pharmaceutical or device manufacturer identify areas of inefficiencies, flaws, and non-compliance. The manufacturer can then take necessary corrective actions ahead of the actual FDA inspection, increasing the possibility that it will pass the actual official audit without significant issues.
  2. Ensure continuous compliance. A mock FDA inspection can help a pharmaceutical or device manufacturer maintain its compliance with FDA regulations, identifying any potential gaps in manufacturing, documentation, or quality management systems and providing an opportunity to rectify any gaps before the real audit.
  3. Boost quality. A mock FDA inspection can improve the quality of pharmaceutical products. It enhances a company’s understanding of FDA regulations and requirements, promoting a proactive approach to quality management that ensures products meet the highest quality standards.
  4. Enhance reputation. A successful mock FDA inspection can boost the reputation of the manufacturer, demonstrating its commitment to quality and compliance with regulatory standards.
  5. Save money. Conducting a mock FDA inspection can potentially help save a pharmaceutical or device manufacturer the significant costs associated with reworks, recalls, or penalties that may result from failed FDA audits. It is a proactive approach that evaluates compliance and helps to avoid serious implications for the company.

 

At Lachman, we believe in proactive strategies rather than reactive responses. By having FDA mock inspections conducted by our CGMP experts, your company’s entire footprint (including suppliers) is in a better position to prepare and perform well for the actual FDA inspection. Reach out to us today at LCS@LachmanConsultants.com to discuss how we can help your firm be proactive!