Hot Story – Yes or No – Should You Shut Down Production During an FDA Inspection?

Hot Story – Yes or No – Should You Shut Down Production During an FDA Inspection?

March 19th, 2013 // 3:43 pm @

March 18, 2013 – Updated March 20

Hot story of the week!

Our recent Webinar speaker, Dennis Moore, AUK Technical Services, noted that while having your production system down during an inspection is not necessary, it can be useful in some situations.

On the ‘no’ side, Moore noted that most 483 hits come on records review, not during production. So, in that sense, having production down is not needed and may not be necessary. You also could arouse suspicion with the FDAer if it appears you shut down production for anything other than routine maintenance. Some commenters below have noted that not being under production during the audit could create problems if you ship to other countries, including Brazil. Authorities there would not issue a GMP certificate in this case.

However, on the ‘yes’ side, if you have your production up, they are going to pull your training records. So, there is a tangible benefit to having your production down – you could have workers on furlough so that the investigator can’t ask them probing questions.

Of course, they’re going to pull your training records no matter what. But if the actual people are not there, it tends to make your inspection go a bit easier on the training side.

Update 3/20  – We received some interesting comments on this topic on LinkedIn.

Commenter 1 noted that this is a tricky question, but is, in her view, widely practiced in the industry. She thinks that this could give a negative impression to FDA.

Commenter 2 stated that shutting down production is something that the company can do. But if FDA wants to observe observations, they will probably ask when production will start up. Also, if the operation includes producing sterile products using aseptic technique, FDA is going to want to observe this.

Commenter 3 thinks that FDA would ask why are operations shut down, and then what should you say. If you say it is down for maintenance and are not truthful, FDA can get suspicious. The key, this commenter stated, is to answer questions honestly and succinctly.

Commenter 4 believes that shutting down production for anything other than regular and scheduled maintenance has no place in your QA/QC program. It never should be for avoidance of accountability, only for maintenance downtime. He also noted that once the inspectors are on site, they can audit any system no matter of the production status.

Commenter 5 noted that production should only be down as part of normal operations. This would be easy to explain to an investigator and would allow you to answer the question honestly. All companies should be prepared through internal review and audit before the inspection. It’s better to sweat during your mock audit than to bleed when FDA arrives.

Commenter 6:

“If you even have to ask yourself this question about your own operations, then you have completely missed the point of what the Quality System approach of FDA is all about. FDA expects you to know your own products and the processes to obtain them well enough to define them in such a way that you consistently get satisfactory products at the end. You are expected to provide appropriate staffing with appropriate training that they will be able to execute the process consistently as defined.

If you have any issues in your factory that would make you uncomfortable about the arrival of auditors, you should identify the issues and implement an improvement plan to remove those concerns – and the improvements should begin immediately. Each project needs to be defined and documented, and the improvements documented, the outcomes checked, both for achieving the desired improvements and for the lack of introducing undesired side effects.

If you are concerned about the training level of your employees, then fix the issues so that you can be comfortable with the arrival of auditors at any time. If you have any concerns about the quality of your process you need to fix them, and not focus on avoiding audit issues.

FDA audits are all about seeing that you have defined and documented what it is that you are supposed to do, and then seeing that you are doing what you have defined and documented, and seeing to it that what you have done is delivering what you planned to deliver. That is both a good way of doing business, and the most cost-effective way of sustaining a business for the long term.

So do things right in the first place and you won’t need to worry about whether production is or is not in progress when auditors arrive, whether they be from FDA or any other agency.”

Commenter 7: “The site should be in operation unless there is a significant issue that prevents the site from continuing manufacturing. Be aware that if the site is supplying to other markets (in particular to Brazil), ANVISA (Brazilian agency) will not issue a GMP certificate to the site unless the site is operating during the Anvisa inspection and furthermore manufacturing the product intended for their market.”

Needless to say, there is a good deal of disagreement on this topic. We’ll continue to post updates as they come in.

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