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Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
Q: We are an established contract manufacturer, and we are preparing for our first inspection by a foreign agency. Although we have many years of experience with our local regulators inspecting us in regular intervals, we are anxious that the foreign inspectors may have different expectations. For example, our employees are very hospitable, but we don’t want this to be seen as offering bribes. Could you provide some guidance and advice?
A: It is indeed good practice to plan well for inspections, for both the technical and also the administrative part. There are numerous articles written on behavioral dos and don’ts during inspections, but these typically only cover how to answer questions and how to provide evidence. What’s equally important is how you treat the inspector when he comes to your site.
Making someone’s life more comfortable and providing hospitality are good intentions, but as you point out quite rightly, it is essential not to cross the line into bribery. The following are some practical examples and ways to act during an inspection.
Foreign inspectors need to travel to your site and most likely will have to stay a number of nights in accommodations nearby. Typically, inspectors will arrange their own travel. Nonetheless, it is simply courteous to offer assistance, such as providing a list of hotels in the vicinity to your site or modes of transportation from the nearest airports. Some inspectors may even ask for more information, such as:
Will there be taxis at the train station?
Will taxis accept credit cards, and if so, which?
Where can I find train timetables?
You could offer to pick up the inspector at the airport, train station, hotel, etc., as this may be the most sensible option. Again, the key message here is to merely offer this as a suggestion. Flights might be delayed, ATMs might not work, public transport might not run, taxis might not accept credit cards, etc. An inspector stranded in such circumstances will most likely accept a pick-up by the company.
Hotels offer varying levels of service, which is well understood. However, good hosts will verify that the rooms reserved are suitable (i.e., are these rooms you would be comfortable staying in? Does the hotel provide basic amenities, such as mirror, hair dryer, bottled water, tea- or coffee-making facilities?). It is always best to verify to ensure a comfortable stay.
It is also a nice gesture to offer food and drink during an inspection; but be sure to inquire if the inspectors have any allergies first.
Similarly, you should ask inspectors whether the room temperature is to their liking; not everyone enjoys glacial temperatures, even in the height of summer.
Some inspectors appreciate if they can spend time in prayer and have a quiet room to retreat to. It is nice to be cognizant of this and offer a room they can use.
The inspectors may wish to spend the evenings, or time before or after the inspection, exploring the area to do some sightseeing or visiting specific events or exhibitions. It is fine to provide tourist information to the inspectors, as long as you do not intend to buy tickets or book tours for them.
If you follow the gist of the above examples, you will be able to show your great hospitality without being seen as unprofessional or even attempting to bribe. These guidelines work for inspectors from all cultures. Good luck with your inspection.
Vol. 29, No. 11
When referring to this article, please cite it as S. Schmitt,"The Human Factor in Inspections," BioPharm International 29 (11) (November 2016).