Preparation for regulatory inspections involves a lot of work. Documents are organized in the final weeks. Standard Operating Procedures (SOP) undergo a quick review. Training is performed again. The whole team works overtime, and finally, everything is ready when the inspector arrives.
However, “looking ready” and “being ready” mean different things. And this is where most pharmaceutical companies fail to get.
Documentation: Not Enough Is Too Much
Many companies think that having any documentation at all means having proper documentation. However, it’s far from the truth. Inspector doesn’t check whether you have a certain document, but verifies whether the document reflects the process properly. He or she makes sure that the batch record, SOP, and the training record for each particular case correspond to each other.
Small inconsistencies are hard to notice sometimes, but they always exist. Revised SOP that wasn’t reflected in the training record; deviation closed without any documented investigation of its root cause; change control that lacks some stages – these are the mistakes that are rarely obvious separately, but that form the pattern when taken as a whole.
Culture Is as Important as Checklists
The second misconception related to the issue is that GMP compliance is mostly about procedures. Indeed, checklists are very important, but they don’t form the culture when compliance is considered as the natural part of the process, not an additional requirement.
The facilities that succeed during inspections have the same property – people at any level of hierarchy understand not just that a certain procedure exists, but why it exists. Understanding the reasons for a certain control measure helps to identify any inconsistencies before the moment when they are discovered during the preparation for the inspection.
Developing such a culture requires not only a revision of the policies, but continuous training and quality management support.
Timing Is Everything
The third mistake made by many companies is waiting too much to get an independent review. Internal team is too familiar with their procedures, and this is why it’s difficult for them to find some blind spots that are obvious for an experienced auditor. The pre-inspection gap assessment done in advance of the inspection gives the company a chance to fix whatever was found during the process, not to prepare some explanations for why the problems exist.
Clinical operations should also be considered at this stage. The facilities that conduct some clinical trials should have their GCP and GMP procedures aligned – inconsistencies between the two is exactly what an inspector can discover during an inspection.
Building Towards the Readiness Instead of Surviving the Day
None of the listed mistakes mean chasing certification or giving guarantees. What it means is that the company develops the proper operational routines, documentation practices, and internal control of the quality system that help to make inspection just another day in the facility’s life, not the day of testing.
The companies that do everything right consider regulatory affairs, quality systems, and audit preparation not as separate processes, but as interconnected components of one process. And this is the difference between passing the inspection and being ready for it.
If your facility is still treating the process of the inspection preparation as a once-a-year rush, it’s high time to find out the existing gaps before the inspector reveals them. Contact us to get more information about our services in the field of regulatory affairs.
Ready to discover your current gaps in compliance? Contact us to discuss your needs.
Would you like to learn more about your facility’s readiness as a whole from the GMP and GCP perspective? Feel free to contact us and ask about a gap assessment for your facility.
