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



Preparing the Manufacturing Area for an Inspection
Remember to clean. Clean offices and work environments are a simple way of making a good impression. Employees should be informed of an inspection and instructed to straighten their offices and organize their files. They need to make sure nothing is left in the open that could cause an issue for inspectors. The sidebar, "Preparing the Manufacturing Area for an Inspection," has further details.

During the Inspection An inspection can be stressful. Before an employee meets with an inspector, there are some dos and don’ts to make sure that the inspection runs smoothly.

Do not panic. Be responsive and courteous. Act professionally and provide the courtesy that should be offered to any visitor. Focus on answering inspector questions and on presenting the facts.

Listen carefully to what you are asked, and respond directly to the question. If the inspector's question is unclear or could be interpreted in different ways, ask for clarification. It is okay to repeat questions back to the inspector. For example, "Do I understand you correctly? You want to see the SOP for cleaning a test tube."

Do not guess. If you don't know something or are unsure of the answer to a question, say so; don't guess. It is perfectly fine to ask the inspector for more time to review the details surrounding the question. The reporter will make a note and keep track of what details still need to be communicated. Moreover, there may be other people who can more appropriately respond to the question. In that situation just say, "Please give us some time to contact the right person for you to talk to, and we will get back to you on your request." The reporter again makes a note and informs the war room to contact the right person to address the need. This is why creating an operation plan and identifying the right people is a crucial part of the inspection process.

Do not be confrontational. When an inspector asks a question, the employee answering needs to keep a level head. If the question feels threatening or accusatory, try to reword it. For instance, an inspector might ask, "Why did you write this SOP?" Turn that question around and ask, "So, you want to know why the company's policies dictate that this SOP be written like this?" Turning the question around to reflect a neutral perspective can often alleviate tension and help return focus to the issue. Stick to the facts, and do not allow emotions to come into play: In this situation, they can have negative results.

Do not play games. Sometimes, when staff do not know the answer or are unsure of an answer, they begin to play games with the inspector. They might try to confuse the inspector by responding to something that has not been asked or by providing information that is not relevant. Inspectors become suspicious about staff that try to mislead them, and they may begin to think that the company is trying to hide something. In a situation like this, it is best to respond by saying, "Let me get back to you on that," or "I need more time to review the details."

Respond quickly and accurately. Because inspectors keep track of what they ask for, the efficiency and effectiveness of the inspection reporter and of the war room personnel can ensure that order is brought to the inspection. A quick and accurate response to an inspector query can leave a favorable impression. Have validation protocols, reports, batch records, SOPs, and other documents available. Pay special attention to documentation relating to deviations, changes, rejected batches, failed tests, and to decision-making processes (such as R&D reports and memos). Inspect file rooms, and make sure they are in order. Locate missing or borrowed documents, and temporarily limit document removal from the file room.

Provide documentation. The inspectors should be provided with the requested documents only. In the war room, review documents to make sure information is complete and accurate. Also, remove from the document given to the inspectors any miscellaneous items like Post-It notes, hand-written comments, or extra pages.

Make two copies of each document you intend to submit to the inspectors. Mark each set "copy," and keep the originals nearby until they can be filed and stored properly. One set of documents should be kept in the war room, and the other set should be given to the inspector. This way, the company has an accurate record of what they provided to the inspectors.

Work with FDA. Too many companies view FDA as a threat. Working with FDA and not against it gives companies an advantage. Treat inspectors as human beings, instead of the enemy. Taking these steps makes the inspection easier for both organizations.

Although no one has a crystal ball and can anticipate any and all requests or issues that might arise during an inspection, being prepared and organized can make your experience a positive one. Hopefully, this article shows that you can organize your interaction with the agency when they are on your site using the same methodical approach you take to the rest of your daily activities.

The last article in this "Survival" series discusses how to prepare follow-up documentation after the inspectors have left. It is designed to ensure that you maintain positive ongoing relations with FDA for any future activities in which you might both be involved.

References (1) Lavian M. and Allen P.W., "Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question," BioPharm 15(8), 20–26, 49 (August 2002).

(2) FDA, "Electronic Records; Electronic Signatures," Code of Federal Regulations, Food and Drugs, Title 21, Part 11 (U.S. Government Printing Office, Washington, DC, revised 1 April 2001).

(3) FDA, "Food and Drug Administration," FDA website (Health and Human Services, Rockville, MD, accessed June 2002). Available at www.fda.gov. BPI


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