7 ways to prepare for an inspection
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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 inspectionif you take theappropriate 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 anorganization 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 manpowerso your employees are not hunting for
records in several different locations. This is particularly helpful if the FDA makes asurprise 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 donthave a set procedure to file this type of documentation, its time to put money and
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manpower into doing so, Quintero-Vives stressed. If an inspector asks about acertain procedure or group of manufacturing recordsand you cant produce them
in a timely fashionthey 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 andawareness 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 theknowledge 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 monumentaltask, 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.
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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 fortoo long, he or she can become lazy. Laziness can turn into irresponsibility, and
irresponsibility can result in incomplete procedures. Down the road, those deviationscould 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 yourcompany, and dont expect everything to be fixed overnight. A company needs to putpreventative 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. Theseseven tips will help instill confidence in the quality standards within your workplace
and build up to a better inspection experience.