If your company is associated with the pharmaceutical industry in any way, whether it be manufacturing, supplying, or research and development, there’s a pretty good chance that your company will be audited with some kind of FDA inspection down the line. When by chance, your company is audited, they will have to pass a series of FDA inspection tests, to ensure that your company is running in compliance to FDA standards, and that all your research and manufacturing information can be verified. But you may be asking yourselves, what are the reasons for pre-approval inspections anyways, and what can my company do to get through it, and pass it the first time around?
The purpose of a Pre-Approval Inspection is for the federal government to ensure that all manufacturing facilities, as well as development facilities, meet all current GMP codes of conduct and stipulations. Their main purpose is to verify that your company’s procedural activities are in line with their own commitments to ensure the authenticity and accuracy of any data contained in your company’s submitted application file. It is the inspector’s job to thoroughly inspect your facility, as well as any records or data you have available, to make sure that your site produces reliable data information, and that all key GMP systems are up to code with current GMP standards.
Thorough preparation work is absolutely paramount when ensuring that your company is successful in getting through its pre-inspection test. For your company to prepare itself sufficiently, many pharmaceutical experts recommend that your company start preparing itself at least 12 months prior to the inspection date. One of the best things your company can do to ensure maximum preparation, is to hire an outside pharmaceutical consulting firm, or life sciences consulting firm, that specializes in pre-inspection audits, and can help your company to prepare itself the best way you can for your pre-approval inspection.
Companies should always be aware that preparing for your pre-approval inspection is not a last minute activity, and takes months of comprehensive training to be adequately prepared. It is also advisable to organize comprehensive training programs for all personnel that will be in any way associated with the inspection. It is not unheard of that personnel behaving in an inappropriate manner, or providing misleading information to inspectors, can cause inspectors to ask further, more difficult questions, as well as cause them to look into areas they may have overlooked.
This is why any personnel staff that could potentially come in contact with an inspector, should be thoroughly trained and briefed well ahead of time, to avoid any possible problems. Your personnel should be instructed on how to conduct themselves around inspectors appropriately, as well as how to appropriately answer questions. Phrases like “I guess”, “normally”, “usually”, “I think”, and “most of the time”, should all be carefully avoided. Because of the wide range of do’s and don’ts associated with pre-inspection protocol, preparing your entire staff well ahead of time will be your best chance to safely make it through the pre-inspection process unscathed.
Nigel Smart
Nigel Smart is a pharmaceutical consultant and founder of the pharmaceutical consulting blog.