Intimidating as they may seem, FDA pre-approval inspections are vital to obtaining final approval from the FDA. You may be well aware that you are supposed to follow all FDA rules and regulations in your facility, but inspectors will still want to know if the whole process of developing a new product was performed under FDA standards and using current good manufacturing practices (cGMP).
This stage demands hard work and can’t be effectively completed without suitable preparation. A pharmaceutical consulting firm will usually advise you to extend these efforts for FDA pre-approval inspection preparation to the whole production process and not just to facility issues.
In consideration of this, some key steps that will help to facilitate the appropriate preparation which should lead to a favorable response might include the following:
1. A thorough understanding of the inspection process:
After analyzing all your application documents, the FDA will dispatch inspectors to check on the accuracy of the application from a compliance perspective.. They will be looking for problems, and if they can’t find them, it’s been known for them to turn the premises upside down, to ensure that there are no show-stopping compliance issues.
They expect you to have some issues (this is only normal), but their main concern is how you address such issues; Is there a plan and on over-riding philosophy and culture of Quality Compliance at the site.
If they gain the impression that your company is trying to control these problems and has a rational plan for maintaining control then, they will interpret that in terms of the site as having a higher quality standard.
2. Preparing for the inspection:
You will receive plenty of advance notice from the agency, and this will give you adequate time to prepare your site for the inspection. This will include: conducting internal audits, educating your personnel about the inspection process, training people to deal with the inspectors (a list of Do’s and Don’ts will be much welcomed), and preparing a document room to provide key documents to the inspection team as requested.
A key part of this process is to make sure that people are appropriately prepared to answer questions about their responsibilities so that they minimize the chances of making mistakes or saying the wrong things Which can lead to ambiguities.
3. Confirmatory evidence:
Generate documented evidence of compliance with FDA regulations; be familiar with all FDA guidance documents and manuals. Review warning letters, prior FDA 483’s, prior establishment inspection reports (EIR). Make a list and check all external and internal documents, watch especially if the in-house documents match the documents presented to the FDA.
4. Managing the inspection:
Prepare an inspection team with clear roles to deal with the inspection and FDA inspectors. Prepare two specific rooms to ease the inspection: an Audit Room where the inspectors can interview your personnel and a Staging room or back room, to keep all the documents at hand and process all of the inspectors’ requests. Conduct mock audits regularly to evaluate your compliance status and see how your personnel responds to questioning.
Even though the preparation of these pre-approval inspections demands a lot of time and effort, it is probably the safest way to approach the process. By systematically performing all of the activities mentioned above, it is possible to both remediate any issue arising from the production or application processes and be ready to successfully address any incident and close the gaps, thus ensuring the highest quality standards and products.
