Would your pharmaceutical company know what to do if the FDA suddenly showed up at your door? Would your senior management be ready, would your staging room be ready? Would your receptionist be ready to handle the protocol that takes place during an FDA audit? Does your pharmaceutical company have the correct documents in place needed for an FDA audit? An FDA citation can set your company back months, even years, not to mention the thousands of dollars in fines your company is likely to face. If you’re not sure that your company is FDA compliant, it would be an excellent idea to hire an outside pharmaceutical consulting firm that specializes in mock FDA audits and regulatory inspection readiness.
This outside pharmaceutical consulting firm will help you understand why you might be getting audited, and prepare your company to pass any surprise or scheduled regulatory inspections, that might be in your company’s near future. They will help you understand the purpose for the inspection, and help you make ready all the necessary regulatory filing that may be involved. They will inspect all the logistics in and around your company and will work to prepare your site according to FDA standards. They will help to prepare your computer and automated systems so that they will be compliant for any regulatory review.
Another important pre-testing measure that an outside pharmaceutical consulting firm can offer is a quality systems gap assessment. These tests are vital for any inspection training that your company is looking for to prepare for your FDA audit. They will test all procedures and analytical methods to see that they are up to par and can be validated. This includes methods for testing, sampling, and data evaluation. They will make sure that all your equipment used for testing and sampling is properly calibrated, and well maintained. Environmental conditions such as humidity, oxygen, temperature, even electromagnetic interference will all be monitored and controlled. They will also work to make sure you have the specific documents in place, such as policies and a specific quality plan.
A pharmaceutical consultancy firm will help provide your company with the tools and expertise needed to prepare your organization for any regulatory inspection, surprise or mandated. They will utilize the inspection results to give your company a competitive advantage while teaching your company how to stay ready long after the initial mock testing is completed. Creating an accurate and thorough system is key to develop an effective regulatory training system, which will help your pharmaceutical company to pass any FDA inspection every time.
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