7 Ways To Prepare For An Inspection

May 16, 2012

By Lori Clapper, Editor In the pharmaceutical, biopharmaceutical, and medical device industries, regulatory compliance is a major responsibility and a common source of anxiety. However, theres no need to stress over the possibility of an FDA inspection if you take the appropriate steps to prepare. This was the guidance Rosario Quintero-Vives, regulatory and compliance specialist with RQV Consulting, offered to a packed room of INTERPHEX 2012 attendees, on the potential problem areas to address before the FDA comes to call. She went on to highlight seven actions you can take to help make the inevitable FDA inspection go more smoothly. 1. Perform internal audits. An internal audit is a useful exercise for any business, because it helps uncover deficiencies that could turn into opportunities for improvement. Quintero-Vives recommended that audits be conducted by an organization recommended by your regulatory agency. Audits should be a complete surprise to employees, in order to capture an accurate picture of your daily operations. An audit should take 6 to 12 weeks to complete and will pinpoint any trouble areas within your manufacturing processes and quality systems. 2. Keep your process validation library in order. All documentation of validation procedures, protocols, purchase orders, and utilities needs to be in perfect order and readily available. Quintero-Vives suggested implementing an electronic database of these documents to save time and manpower so your employees are not hunting for records in several different locations. This is particularly helpful if the FDA makes a surprise visit, so as to not keep the inspector waiting. 3. Update your general library. Its also important to organize the latest versions of standard operating procedures (SOPs), protocols, manufacturing records, quality procedures, change controls, batch records, and logistics documents. If you dont have a set procedure to file this type of documentation, its time to put money and

manpower into doing so, Quintero-Vives stressed. If an inspector asks about a certain procedure or group of manufacturing records and you cant produce them in a timely fashion they start to get suspicious that something is wrong. 4. Create deviation dossiers. Quintero-Vives loves her dossiers! She couldnt emphasize enough how important these records are in showing you have control and awareness of your facilitys operations. A dossier will contain vital reports and other information on circumstances that could influence your final product, including procedure changes, prior FDA investigations, or weather conditions. She added that a problem can originate from so many different places. Creating a dossier means the knowledge you need is in one place, and it enables you to more easily identify where things went wrong. 5. Segregate documentation. You should keep records separated by department (manufacturing, engineering, etc.) for easy access during an inspection. These records include, but are not limited to:

Logbooks Maintenance records and procedures Cleaning validations Technical change requests (TCR) Installation operational qualifications (IOQ) Installation qualifications (IQ) Operational qualifications (OQ)

6. Create customer complaint dossiers. Even though it sounds like a monumental task, Quintero-Vives expressed that it is essential to track every complaint, especially if problems recur. She pointed out the following steps you should follow when handling customer complaints:

Open a corrective and preventive action (CAPA) project on the matter. Make sure you have the manpower, in house or outsourced, to answer every complaint. Take the time to figure out the root cause of the issue. Let your consumers know what steps you took to solve the problem.

This is another example of how an electronic database can be an excellent tool to help you create a matrix of all your raw materials, equipment use, packaging components, etc. The data supplies supporting documentation on your reports regarding consumer complaints, and it will be stored in one place.

7. Hold onto cGMP training documentation. Good business practices are vital, especially in highly regulated industries. It comes down to either losing money or making money. For example, if employees are poorly trained, you run the risk of wasted materials or equipment negligence. If an employee has performed a task for too long, he or she can become lazy. Laziness can turn into irresponsibility, and irresponsibility can result in incomplete procedures. Down the road, those deviations could result in nonconformance and customer complaints, Quintero-Vives said. A company that motivates its employees to learn new techniques will make them a part of the solution, rather than the problem. Quintero-Vives encouraged everyone to participate in an internal audit every year to keep employees continually involved in the optimization of your facility. She added that its very easy to underestimate the importance of organization within your company, and dont expect everything to be fixed overnight. A company needs to put preventative measures into place at least six months before an inspection, she told the audience. Putting your house in order is never too expensive or unnecessary. These seven tips will help instill confidence in the quality standards within your workplace and build up to a better inspection experience.