by Alex Pavlovic

Nanopharm case study: building an ISO 17025 management system

Founded in 2002, Nanopharm is a highly specialised medical device research and development company focusing on orally inhaled and nasal drug products (OINDPs) such as asthma inhalers. Working with pharmaceutical minutiae from pulmonary performance to droplet dissolution means Nanopharm's operational quality must be at the highest standards.

Nanopharm's Head of Quality Susanne Durie discusses why she chose Qualsys's software solution to construct an ISO 17025-compliant management system and embed good laboratory practice (GLP) across the Nanopharm operation. 

 

Image result for nanopharm

 

Qualsys: Could you tell us a little bit about the quality and compliance framework that Nanopharm is currently working to?

Susanne: I joined Nanopharm from a quality background with experience of implementing and working to ISO 17025, which is a formal accreditation setting out the general competence requirements for laboratory testing. At that time, the goal was to work to achieving 17025, but subsequently we've broadened our focus to also include working towards the principles of good laboratory practice (GLP) and becoming registered with the Medicines & Healthcare Products Regulatory Agency (MHRA). So those are our quality objectives.

ISO 17025:2017 is the benchmark for consistent, impartial, competent laboratory quality

 

Qualsys: What exactly is good laboratory practice? What does it mean?

Susanne: The principles have been developed over the years but the fundamentals remain the same: it's about making sure that the data we get and use is fully traceable and of high, consistent quality. GLP is really a statutory instrument for producing pharmaceutical products - you have to follow GLP along with good manufacturing practice (GMP) if you want to produce and sell products on the medical device market.

 

 

Image result for nanopharmNanopharm has a string of patented OINDP technologies

 

Qualsys: So how do those two objectives, ISO 17025 and GLP, align with your broader business objectives? Is it about entering new markets and growing?

Susanne: It's about providing more assurance to our customers about the quality of our products, and creating high-quality medical studies which can be used to get our products to market. We're all research and development at the moment, so we have to get the GLP framework in place before we can go out to market ourselves.

Image result for nanopharmNanopharm specialise in one of the human body's most complex organs - so Susanne was keen to construct a formalised, accredited quality system using Qualsys's software

 

Qualsys: What drove you to source and implement an electronic quality management system?

Susanne: I was brought in primarily to build a quality management system for Nanopharm, and I recognised immediately that we needed a document control process so all our staff could access up-to-date documents quickly and easily. Because we were starting from scratch, we needed a mechanism that would build good documentation practice into our wider infrastructure.

We needed to ensure all our quality documentation was official, formalised, up-to-date, authorised, and together in a single place so our staff would know exactly where to go to find what they needed, and information would be shared without ambiguity - so there'd be no confusion about whether people were using the right version of a document. 

Nanopharm became Qualsys customers in 2017

 

Qualsys: What sort of things were you looking for during the procurement process, and why did you choose Qualsys in the end?

Susanne: We were looking for a solution that would give a comprehensive mechanism for managing the whole quality system and which we could build our management policies and processes into. 

Obviously, for a comprehensive quality system we needed an auditing function. We found Qualsys's document management module, and also your audit and issue management modules. Audit Manager gave us the mechanism for capturing audit observations and non-conformances while Issue Manager allowed us to address them. We have a full audit programme planned, which we'll use Audit Manager for. I think Issue Manager will also prove useful for so many other things like building a proper data breach management process, which we need for GDPR compliance. I'm not sure how we would have done that without Issue Manager - so that was a real benefit.

The directors and I looked at other systems that I'd used in the past with other companies, like Vivaldi and Ideagen and a few others, but ultimately what swung it for the directors was the visual layout of the GRC dashboard, where they could view a snapshot of completed and upcoming actions and view the general health of our quality system. I think that was the key for us. Also it was cost-effective and the modules just fitted in quite nicely into our operation.  

 

We needed to ensure all our quality documentation was official, formalised, up-to-date, authorised, and together in a single place. We were looking for a solution that would give a comprehensive mechanism for managing the whole quality system.

 

Qualsys: How do you think the Nanopharm team will benefit from that mechanism being in place?

Susanne: I think the main benefit will be having information to hand wherever they are. Because it's a cloud-based solution they can access it anywhere - and our directors travel a lot. For them to have a secure and comprehensive set of documents that they can always refer to and share with our customers, I think is incredibly important. I really like the reporting widgets on the dashboard, and the ease of accessing the system anywhere. 

 

OINDP specialists Professor Rob Price and Dr Jag Shur are the managing directors of Nanopharm, and opted for Qualsys's solution for the simple visuals of the GRC dashboard

 

I think Issue Manager will also prove useful for so many other things like building a proper data breach management process, which we need for GDPR compliance. I'm not sure how we would have done that without Issue Manager - so that was a real benefit.

 

Qualsys: And how will you be measuring the success of the project? What's your 'north star' for the next year?

Susanne: I want to see all our customer protocols added into the system so everyone accesses those rather than printed copies, so we can guarantee we're working to the latest procedures. I want everyone to use the system - so I'll be monitoring who has actually been signing in and what kind of documents they've been utilising.

It's about having the confidence that people are working to the current procedures, they're aware what changes have been made, and they know what controls are in place. That's how I think EQMS will benefit the entire business.

When I started, we had no formal quality management system in place at all, so we're still building up our document base which is a pretty monumental task. But our aim is to become GLP-accredited within the next year and then take ISO 17025 on top of that afterwards. 

 

Our directors travel a lot. For them to have a secure and comprehensive set of documents that they can always refer to and share with our customers, I think is incredibly important.

 

Qualsys: Thinking of you as a quality professional, then, what sort of things are you looking for when you walk into the office every morning? What does your daily routine as Head of Quality look like?

Susanne: Currently I'm looking at developing our infrastructure. I'm trying to develop our whole documentation range from management to electronic security. GDPR is a big thing which I'm focusing on at the moment. And we're also looking at implementing quality checks of all our day-to-day operations: the balances, the pH meters, the water, the instruments themselves like our HPLC (high-performance liquid chromatography) and GC (gas chromatography) instruments. I have to make sure that all these checks are being performed and documented, so we can then start auditing against them.

 

When I started, we had no formal quality management system in place at all. Our aim is to become GLP-accredited within the next year and then take ISO 17025 on top of that afterwards.

 

Qualsys: What's your favourite part of the role?

Susanne: I really enjoy streamlining things, to make operations more effective and efficient. Rather than people not knowing what to do and making things up as they go, having a formal quality system helps people perform their day-to-day jobs. That's what I get out of my role.

 

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Nanopharm's head office is based in Newport, Wales 

 

I really enjoy streamlining things, to make operations more effective and efficient. That's what I get out of my role.

 

Qualsys: What kind of challenges do you face as Head of Quality?

Susanne: I think the main challenge is making everyone conscious of the effort involved in formalising quality. The company expanded very quickly so a lot of things were done on spec - which is fine - but obviously it takes a lot of resources to then convert that style into a formalised system. Because the company's growing so fast, it's hard to get hold of people too. 

In the long term, getting people to sit down and work to standardised documents with EQMS will help. Getting everyone involved in the system and using it together will unify our processes and help us get to GLP.

 

What to do next

See what our other pharmaceutical and life science customers achieved with our software in our case study booklet

Aiming for ISO 17025 yourself? Read our blog post to understand the key management and technical requirements of the standard. 

Or schedule a 15-minute call with us today to explore how our software modules can be used to build a comprehensive medical and pharmaceutical quality management system.

 

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