Facing FDA inspection is being critical day by day because FDA is inspecting pharmaceutical units at very short notice period. This makes it critical because of having a short period of preparation. FDA is doing this because they want to develop a quality culture in pharmaceutical firms instead of a culture where quality is maintained before inspection.
When you get an information that they have a planned visit to your facility the day after tomorrow then you start asking yourself many questions such as are we prepared? What do we need to get ready? and many other similar questions.
One important thing to have when faced with this scenario is to have the right attitude. Why? This is because your attitude matters a lot. Generally, as humans, we dislike inspections of any kind because we take it as criticism in what we have invested in.
But remember if you take criticism in a positive way, you will be able to comply with the set regulations, improve your systems, processes and more importantly grow your company.
But remember if you take criticism in a positive way, you will be able to comply with the set regulations, improve your systems, processes and more importantly grow your company.
Let us begin with some of the most common questions the inspector will ask. How and where the company’s data is recorded? Date of which the first subject was screened and consented? How do you handle quality assurance? Did reporting of adverse events to IRB performed in an appropriate manner? The delegation of authority in that company? Correct date of any follow-up on a study subject? This and many more questions are to be expected from the FDA inspector because he/she has been authorized by law to do so.
Related: Tips to Reduce 483 Observations
Related: Tips to Reduce 483 Observations
The best you can do is to prepare. The following guidelines will enable you to prepare adequately for an FDA inspection the next time you receive that short notice of inspection.
1. Once the inspection start date has been scheduled, you should conduct a Freedom of Information (FOI) search on the name of that inspector/officer. This will help you to determine if the officer has previous GLP, GMP and GCP inspection and in specific areas. You might also check review types of the previous FDA 483s which he/she has issued and also what he/she is prone to review.
2. Prepare your personnel by educating them about the inspection process. Coach them on how to interface with the FDA inspectors. Certify that training was provided for all the personnel concerning their current job functions and the supporting records have been filed. This will go a long way in minimizing chances of giving incorrect answers or maybe providing unnecessary information.
3. Be familiar with FDA regulations as applicable, FDA guidance documents, FDA guidance manuals for inspectors. Review previous warning letters from FDA, prior FDA 483s, prior establishment inspection reports (EIR). Relevant documents and records should also be reviewed and ensure that they are readily available. Some of the documents to consider for the preview are batch reports, training records, non-conforming report, operating procedures and others.
4. It is advisable to prepare a team to manage the inspection and each member to have a clear role. Rooms should also be identified to ease the inspection i.e an audit room, this is where the personnel will be interviewed by the inspector and a staging “war” room where documents will be set up and all the requests by the inspector will be processed.
Related: Preparation for GMP Audit in Pharmaceuticals
Related: Preparation for GMP Audit in Pharmaceuticals
The personnel in the audit room should include an escort; the key personnel who will accompany the inspector, he/she will also be answering most of the questions, the scribe, he/she will be keeping detailed notes about the audit including discussed topics and questions asked, the runner, he/she will be sending requests to the staging room in order for them to be processed, subject matter expert, he/she will answer any technical questions that the escort cannot answer.
In the staging room, the following personnel should be present; room head, to lead the room, coordinator, to obtain the request from audit room runner, reviewer, reviews documents sent to the inspector and runner to handle any administrative duties.
5. You can also carry out a mock audit, this will help in evaluating the status of compliance with the company and how personnel responds to questioning. Here are some of the things you must not do during the inspection, don’t sign affidavits, don’t allow recordings, don’t over speak or say it’s impossible, and don’t engage in argument. Other things you should do is to refuse the inspector to access financial data, internal audits, supplier audits and sales values.
Finally, do not fear an FDA inspection if you are adequately prepared because FDA will not expect your company to be perfect, the only thing they want is to see how you address your company’s problems because every company has issues.
Get documents for Audit preparation in MS-Word FormatView List
goooood
ReplyDeleteVery Helpful. But I think that FDA inspectors have the right to internal audit system and reports.
ReplyDeleteSelf inspection report can be seen I think
ReplyDelete