When facing a GMP audit or GMP inspection by a regulatory body, you want to be ready. As ready as you can be. But where do you start? How should you answer queries? And what does an inspector look at?
We've hosted hundreds of GMP inspections. What we can do for you? Prepare your organization to the best of our ability.
WHO prequalification audit support
When you're going to be inspected by the World Health Organization (WHO) you must prepare yourself optimally. WHO GMP inspections are detail-focused and can last up to two weeks in length. Get help from experts who have hosted dozens of WHO inspections, including WHO prequalification audits.
EU GMP inspection preparation
Member states of the European Union have their own national regulatory authorities, like the Dutch IGJ and the German BfArM. When you are going to be inspected by a European regulatory authority you have to know the EU GMP and local regulatory requirements. We help you get ready for a succesful EU GMP inspection.
U.S. FDA GMP inspection preparation
The U.S. FDA performs GMP inspections worldwide. Manufacturers of pharmaceuticals and biopharmaceuticals which produce in the United States or export to the United States are subject to FDA inspections. FDA inspectors have a different mindset than WHO or EU inspectors. Since 1990 we have helped clients prepare for U.S. FDA GMP inspections. All our clients were FDA approved. Let's apply our experience and lessons learned to your company.
One minute rule
Helping you keep the inspector's eyes off his watch and on your documents
Surprisingly, inspectors like things to be well organized. We tidy up your quality system.
Ready for liftoff
Getting your team prepared is our core business. When it's time, your team will be ready.
When you are planning a journey, you start at the beginning. The same goes for inspection preparation. We perform a GMP gap analysis to determine your current compliance status using a compliance matrix. It contains seventeen essential compliance elements.
Sanitation & Hygiene
and many more...
Now that we know your GMP compliance status, we start drafting corrective actions and preventive actions. Basically, we are going to make a project plan.
With this project plan we have a way forward. Training plans are set in motion, documents are created or modified and the whole organization is prepared, using the GMP quality matrix. Until all items on the matrix are at an optimal score.
We are happy to visit your organization for an introductory meeting. During this meeting, one of our GMP experts will visit you on location or digitally.
During the introductory meeting we discuss your current status and what may be required to prepare you for the regulatory inspection/client audit. Subsequently we will draw up a project plan for your review.