Conducting the Audit - Ready or Not, Here They Come - - BioPharm International

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Conducting the Audit - Ready or Not, Here They Come


BioPharm International


It's late Friday afternoon, and you just got off the phone with FDA's district office. An FDA inspection in a few short weeks chases all other thoughts from your mind, which races with questions: "Are we prepared for an inspection? We need to create a project plan and to identify the right people to help; isn't the QA manager out of the country? A few weeks isn't enough time! What should we do?"

An FDA inspection can be a nightmare that costs your company money, time, and reputation, or it can be an opportunity to understand the logic behind FDA regulations and to prepare accordingly. This article series reminds proactive managers of the preparation needed for inspections — whether those inspections are from FDA, a client, an investor, or a European agency. The first article in the series recommended that, before an inspection, companies examine their standard operating procedures (SOPs), monitoring systems, validation programs, and batch record management to ensure that they meet appropriate guidelines (1). If the guidance in Part 1 of the "Survival Guide" has been followed, your company has:

  • invested the necessary resources toward understanding deviations and finding corrective actions to prevent them in the future,
  • established change controls and documentation practices that are carefully followed so that your company can respond to any type of problem,
  • and provided up-to-date training with training records in order, particularly for those functional units and those individuals who have been responsible for deviations, exceptions, or errors.

In this part of the series, we discuss what to do when notified by FDA that an inspection is imminent. Our purpose is to outline the common issues that companies encounter during FDA inspections and to discuss how best to prepare your company for its response (2,3).

One Month Before FDA has just called to say that they will be conducting an audit of your facility within the next month. Before you panic, remember that there is still time to prepare for the inspectors' arrival and to ensure that everything is running smoothly. At this point, you don't have time to design or implement major initiatives. The goal is to put everything in its place.

Remember that some inspections are unannounced. So you must have your organization and plans in place, anticipating that an inspection might start at any time.

Review previous inspections. The first step is to take a close look at results from previous inspections. This is often where inspectors begin their investigations. Determine what commitments your company previously made from a corrective action perspective and whether or not those commitments have been addressed properly. If all commitments have been met, make sure the appropriate documentation is complete because inspectors may want to view the progress that has been made to date.

If previous commitments remain unaddressed, determine why, and identify what documentation has been completed. Create a new action plan providing details on how the company is addressing the issue and listing an anticipated deadline for resolution.

Complete open items. Next, complete any open item (activities that have been started but are not yet complete) documents and investigations. Determine which documents or activities need minor adjustments or approval signatures only. Those items must be approved and closed. Remember, if a document or investigation is incomplete, it is considered nonexistent and can be one reason for a citation.

Institute an operation plan for the inspection. An operation plan is an audit guide needed by every pharmaceutical and biotechnology company. Operation guides are the crucial — maybe the most crucial — method for ensuring that your company is prepared to respond to any issues raised by inspectors.


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