Tag Archives: pre-approval inspection

The Cupboard of Shame

Many people like to be able to present a clean, well-ordered home when they are expecting visitors. Some even prefer to have their home “inspection ready” most, or all, of the time.

skeleton-closet_smallerThis goes for our work environment too, especially if these visitors are about to audit us. So it’s common during preparation for audits to tidy-up and clear out any junk or items that have accumulated for a variety of reasons. There’s nothing wrong with tidying up and audits are often a good prompt to do those annoying jobs that we have been putting off. Jobs like finding out how to dispose of some nasty chemical or how to recycle a load of plastic parts. However, as with tidying your home there can be a reluctance to throw some things away, even when you know you should, because at some point they may become useful or someone may ask for them.

A while ago, our team was supporting a client’s regulatory audit. The whole site was looking pretty good; tatty old labels and signs had been updated, benches were clean and everything was labeled to within an inch of its life, everything was looking spick and span. The site was ready.

On the first day of the audit the inspector asked to be shown around the site. The site tour included laboratories, manufacturing and packaging areas, the waste disposal area and the warehouse. The site tour was going well, people were looking happy and were able to answer the inspector’s questions satisfactorily. All was fine, until the “cupboard of shame” was discovered lurking at the back of the warehouse. Now of course the cupboard wasn’t really called that at the time, but thanks to the back-room team, the name stuck. The cupboard looked harmless enough, it was padlocked closed and was very small in size. However, when the inspector asked about the contents, signals started to be given off that something may be wrong. There was a lot of shuffling of feet and sidelong glances and it took a while to find someone who had a key.

Danger, Will Robinson!The padlock was unlocked, released and the cupboard doors swung open to reveal the contents; lots of “odds and sods” items, the stuff that really could have been disposed of long ago.

There were several boxes of a product from another site, no longer in production and years past its expiry date. There were end of reel labels and ”spare” plastic bottles, device components, plastic bags. A lot of the stuff had been kept just in case it may be useful, one day.

Now, the people who knew about the “cupboard of shame” weren’t doing anything malicious and genuinely had good intentions, they had even padlocked the door to restrict access. But none of that prevented the inspector’s discovery appearing as an observation in the final audit report.

red-light_smallerYou can bet that their “cupboard of shame” no longer exists after that unfortunate series of events.

Do you tidy up for every visit, or do you prefer to be “inspection ready” all the time?

Whichever your preference, what’s hidden in your “cupboard of shame”? You may welcome a fresh pair of hands helping to sort it out.

This might just save your life, in an inspection!

Last time, I covered the top 9 deficiency areas that regulatory agencies in the EU and US encounter when inspecting medical device, combination product and drug product manufacturers.  There were many similarities between the gaps found across these three disciplines.

It seems only natural to then share a way of pro-actively attacking these gaps, so here it is….

Our inspection lifeboatAround the middle of last year, we were asked by a client to help them prepare for pre-approval inspection for their new medical device.

Like them, you may have developed a medical device or combination product, and particularly if you’re getting ready for pre-approval inspection or routine audit, you may want to know more about the areas that could be investigated.  As with many things in our industry, the FDA take the lead in describing the scope and content of their Quality System Inspection Technique (QSIT for short).

In brief, the QSIT approach describes four areas that investigators can cover during an inspection (they typically cover at least 2 of them); Continue reading

Correct these 9 deficiencies to avoid becoming regulatory inspection road-kill

It’s not unusual to be thinking about how regulators will see your product development and where they may find holes.

The closer you get to submission of your newly developed device or combination product, the larger this probably looms in your mind.

It can be useful to see what the recurring issues uncovered during inspections are, but you could easily spend days sifting through inspection trend information available online, without understanding what it actually means for you and what should you be doing now to avoid being part of the deficiencies statistics for 2015.

Top observations found during inspections of both pharmaceutical and medical device manufacturers are reported each year by the US regulatory agency, the FDA. Traditionally these data are reported as separate datasets in both the media and trade press. However, it can be very useful to see what’s happening on the other side of the fence. Some may say the view over the fence is critical for those developing a combination product. After all, these devices must comply with the requirements of both the Quality System Regulation and Good Manufacturing Practice.

The picture in Europe is less easy to determine, as inspection trends aren’t routinely published. That aside, the most recent data published by MHRA indicates very similar themes to those experienced by FDA.

There are actually common themes across both drug and device inspection deficiencies (links to the full lists of FDA observations and MHRA inspection deficiencies are at the bottom of this post). The good news is that getting it right for one field will cover a lot of what’s problematic in the other.

Common areas of concern for the agencies included; Continue reading