Tag Archives: GMP

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

Four becomes five

We’re delighted to welcome David Andrew to the Three Circles team.

David Andrew photo for blogDavid brings a wealth of practical experience of software development and validation in regulated industries, including nuclear, along with a wicked sense of humour!  His expertise is a strong complement to our skills, helping you develop medical devices incorporating software so they’re compliant from concept models through to regulatory submission.

Matthew and David have previously worked together on quality and validation projects for pharma and biotech clients, having lots of fun while getting the job done quickly and thoroughly.  So it’s great to have the opportunity to work together again.