QP Qualified Person

Qualified Person and Digitalization

NCF Notiziario Chimico Farmaceutico – Nr 5, June 2020 – by Mirka Broccato

The Covid-19 tsunami has further confirmed to what degree Digitalization plays a central role in enabling remote working in total compliance if conditions should require.

The role of the Qualified Person (QP) is to ensure the quality of a medicine, employing the use of GMP. In regard to GMP, a medicine does not only comprise of packet tablets or ampoules, it is also a representation of quality systems in the company that produces it, of good practice in managing various machines, documents and data, while also a representation of the competence of those who produce it, who check and verify the appropriacy of processes and so much more.

And so, the question we ask is – how can an individual today, in all good conscience (even at the risk of penal violation!) guarantee that all aspects related to the production of a medicine work as they should? and even consistently in the long term?

It was once thought that the job of ensuring the quality of our medicines lay in the hands of Quality Control. QPs placed their trust in laboratory technicians, their samples and the results of their analyses to assure us that the product was compliant and of sufficient quality. Then it was found that, however statistically viable a sample can be and as much as one can choose, develop and validate supposedly reliable analytical methods, things can still go awry, slipping under the QC’s radar. The temperature in a reactor can rise due to a probe malfunction, risking product longevity, subsequent complaints or call-backs of the product in the market.
It may occur that a machine technician replaces a machine filter with an identical part that however is not produced by the same supplier, resulting in spikes in colour profiles presenting seemingly inexplicable impurities.

All considered, how can QP provide compliance guarantees and the adherence to the rules that are expected of it? How can science in all good conscience ensure that the quality of the process as a whole is met with certainty or at least with a sizeable degree of safety?

Increasingly, thanks to the availability of new digital technologies, the answer is clear: we require systems and infrastructure that can gather our data and process it. Granted that there will always be competent and experienced technicians, trained in the use of digital systems who will analyse, interpret and gather the required information to allow QPs to make informed decisions.
In short what is required is: integrated digitalization projects aimed towards the specific needs of the company.

QP and the production process

Digital solutions such as the Manufacturing Execution System (MES) are required, that collect (from the plants and control systems) the critical process parameters (CPP). Our production experts interpret CPP at a glance but if such a single glance is misplaced even for a moment, data can be lost forever, and with it the chance to comprehend the true reality of the lot in question.
It is necessary to guarantee the ability to connect what happens during the production of each batch to what will happen when it’s being analysed and onwards to its distribution in pharmacies.
Vital data from processing is used by QPs to monitor production trends and allows them to make the right decisions in a timely manner whenever required, even when they are not physically present in production workshops, as can always happen, but could be especially required in times such as these.

Quality Processes

We require digital solutions that allow us to align departments that are only seemingly misaligned. To promote a culture of information exchange and ban silo work forever. An example being Enterprise Quality Management System (EQMS) solutions, with which we can align the Purchasing and Logistics Department with Development, Quality Control, Quality Insurance and production.

Does the Purchasing Office have anything to do with it?

Indeed, It does!

It is involved for example, when the supplier of an excipient unexpectedly stops supplying us with raw materials because (as we have learned very well in recent times) a global health emergency put markets in the red. We would then be required to seek out alternative sources, evaluate immense quantities of documentation quickly as production has already been scheduled.
It is at times like these especially that a digital solution can render change control processes efficient and safe, ensuring that any and all relevant players are placed to offer their conclusions quickly and objectively.

The Labs

We require digital solutions that allow us to collect data from labs and allow us to quickly combine the progress of a process parameter (CP) with that of a critical quality attribute (CQA). These are Laboratory Information Management System (LIMS) and Electronic Laboratory Notebook (ELN) solutions.
Systems that allow us to compare grain profile trends in a component together with the mixing times of the product that encapsulates it, in order to understand that a supplier has changed process and set our CQA adrift.

Only with such information at hand can technologists fully understand processes and intervene in advance, before non-conformity is flagged, before the need to duck for cover with a batch of product ready for shipment in hand.
Only when armed with is information is the QP able to express an overall judgment of a medicine’s compliance, even if forced to oversee a workshop far from their normal workplace.

The Complexity of Plants

Futhermore: How can a QP perform the task of checking the adequacy of plants, as in Chapter 3 of the GMP?

We cannot assume they possess never-ending insight and availability and should be expected to personally verify the compliance of each and every machine in the workshop.
To ensure process quality, integrated digitalization projects are needed that are targeted to the specific needs of the company.
In order to ensure that plants who we have produced a batch of medicine with are in acceptable states of maintenance, adequate information must be made readily available once again.
A company that employs a Computerized Maintenance Management System (CMMS) solution is a company that securely and quickly ensures traceability between medicines batches, production machines and maintenance status.
It is a company that (if faced with a complaint or non-compliance) is able to make an appropriate and fast root cause analysis.
It is a company where its key individuals immediately possess the information to identify effective CAPA when required and no matter they are.
And not a day later. A day could make a big difference!

The Role of “Surveillance”

Lastly, how can the QP ensure that each and every batch of medicine has been produced in accordance with GMP and marketing authorization?

Every day (with a personal signature) the QP is responsible for ensuring that every activity carried out to convert raw materials into medicine has been carried out properly. That such tasks were performed in accordance with approved procedures and methods. With procedure and methods that our authorities have given the green light to.
The best way in which a QP can have sufficient peace of mind as a guarantor of this surveillance role in modern times is to be able to rely on a system that exerts active control over every single phase of the manufacturing process. A system which collects data as generated, that interacts and alerts you where and when an event falls below the expected standard.
Yes, we are still talking about a digital solution, that is, an Electronic Batch Record System (EBRS).
Designed and validated properly of course.
With a complete electronic BR available which is accurate and readable the rollout of a product can be set in motion with confidence, even remotely. As may be required, in particular, in Covid-19 times.

Is Digitalization for everyone?

The Digitalization of a company is unfortunately still perceived as a lengthy, expensive process for small to medium Italian companies, but this may not be the case.

One of the strengths of the digital solutions available today (also thanks to the advent of 4.0 technologies) is that yes, they can be integrated, yes they are easily validated, but above all they can be realized one step at a time, based on specific requirements and with sustainability in mind.
It’s important to know how far you’ve come and the goals you wish to achieve. Know the key processes, map them and draw out strengths and weaknesses, also and especially in a view towards efficiency and compliance. Establish benefits achievable with the resources available, aware that you are beginning a journey of continuous improvement in regard to your destination, stop offs and individual steps.

QP and the Digital Company, attracting business.

Digitalization projects allow significantly increases in the usability of information at all levels, not just for QPs.
A Digital Company therefore provides itself with the opportunity to detach itself from the mindset of the physical presence of personnel and opens up opportunity not only for active surveillance but also active remote operations, creating the right substrate for the development of smart working and also of different key functions.
The story of recent times tells us that a digital company is also a more resilient company: in times of emergency it is able to maintain the fundamental processes within the business.
For QPs, it’s helping to ensure that drugs – whose quality and adherence to regulations they monitor every day – continue to arrive in a timely manner to the patients who need them.
pharma 4.0


Automazione Industriale di Valeria De Domenico


With time currently sort of frozen, we endeavour to carry out a furthering of the Italian pharmaceutical industry, an area in which our country boasts multiple worldwide merits and a recent trend of excellence. Italy now more than ever lays claim to its standing, with the health and wellbeing of all at the forefront.

On such issues we sought comment from Teresa Minero, Founder and CEO of LifeBee – a Consulting and Digitalization Company in the Life Science sector – and President of ISPE Italy, European Leadership Team, Global Steering Committee SIG Pharma 4.0™- a non-profit association of pharmaceutical and Life Sciences professionals, who we thank for her time.

“As was clearly laid out in a statement from Farmindustria in the latest hours (12th March for those who read, ed.) the pharmaceutical sector, and that of the Life Sciences in general, play an important role in society, and most certainly cannot permit disruption in the distribution and production of essential drugs or medical devices, let alone active clinical trials, which would risk invalidating years of work.” Minero tells us.

“This affects those with Covid-19 and indeed the many who continue to be ill and unfortunately require treatment that cannot be postponed, one example being cancer patients. The pharmaceutical industry has taken important measures, from the introduction of smart working for office based services, to implementation, for necessary onsite activities, of continuity and emergency plans to guarantee essential services, while protecting the health of operators and employees.
LifeBee too (which regularly provides essential consultation and support to customers, such as in Pharmacovigilance and Regulation or Production, in Laboratories or in Quality itself) has been found on the mark.
I hope that we will remerge from this intense experience with a greater awareness of the importance of new technologies, to be used intelligently with a view towards sustainability and solidarity.”


When discussing the topic of Pharma 4.0™ in April 2019, Minero concluded by defining the phenomenon not as a revolution, but as “full evolution”, since most Italian pharmaceutical companies have been moving towards this type of change for years, if only dotted and sparse.
From the joint LifeBee & Sparta Systems meeting last February (dealing with Quality Management in Pharma) several more “psychological” obstacles have emerged, even if the new formula of the Government’s Industry 4.0 plan (which expands investment to potentially non-physical technologies if required) could become an additional incentive for Quality Management Systems.
Incentives provided in this direction can certainly help to strongly increase (even among “late adopters”) prospects for integration and digitalization of information: let’s not forget that this is one of the strong points in the 4.0 vision.
I must remind myself that all too often in Italy the 4.0 Industry has been perceived as exclusively linked to production machinery, precisely because of the limit set down by legislation to only benefit from incentives when investments are linked to material goods. The constraint has now been removed, and this could most certainly help the 4.0 revolution to escape from production lines and progress to departments such as Quality, Logistics, Regulatory and R&D.
Moving more specifically to Pharma 4.0™, information sharing can and should be represented in the continuous improvement of processes within the company itself, but also and above all in the increase of regulatory compliance.
The topic we delved into in our February 5th workshop in Milan on “Innovation 4.0 for Quality Assurance Management” is certainly well-fitting. It deals with automating the management of operating procedures, the management of so called Change processes, of Non-Compliance, Market Complaints, CAPA (Corrective Actions & Preventive Actions), Quality Audits (whether internal or external) of Training, to name the main players. There are undoubtedly several regulatory incentives in place, and I would like to highlight a regulation (one of many) currently being established in Europe on IDMP (Identification of Medicinal Product) and still little known. It regards the submission of basic data to the authorities regarding a medicinal product.
The submission of said data is a process that even in its current form requires a lot of manhours.
IDMP rules provide for an extremely high-level international standardization of shareable data in the direct interest of the patient. These involve a review and often a tuning of information flows within the company, allowing for great potential in all directions with the intelligent use of Digitalization.


Recent experience indeed (sometimes even just test cases) of activity improvements with digital technologies in key Pharma 4.0 call to attention even the most distracted. Such examples are many, some even unexpected, such as interesting initiatives involving Blockchain technology, seemingly futuristic but with very intriguing prospects. Probably the most important example however, which sums up very well what is currently happening, is the Italian Pharmaceutical 2030 Manifesto.

The 2030 Manifesto (in which major companies such as Dompè and Sanofi took part and which was then presented to the Senate in September 2019) nominates Pharma 4.0™ among strategic objectives and digitalization among areas of operation. First impressions upon reading the Manifesto do indeed provide long lasting assurances, but an important offshoot is highlighting the theme of digitalization, spreading a signal that we are convinced will be picked up by many.
In short, in order to return to the image of a spotted Italian Pharma 4.0™, we expect that the area begin to clear and take on a uniform coloration.

QUALITY & Artificial Intelligence

A preferred representative in discussions put forth by LifeBee is certainly Sparta Systems – a company active in the market in offering compliance and quality management solutions, which has introduced the topic of Artificial Intelligence in QMS. Fabrizio Maniglio (the company’s Solution Engineer) tells us more.

“Artificial intelligence can be exploited to help discover the meaning of quality management data basing on relevant past information, thus enabling better productivity and intelligent decision-making within an organization. We have structurally incorporated artificial intelligence capabilities to support decision-making processes in our product: two examples can offer an idea of their potential. The first is automatic classification: by applying machine learning and natural language processing algorithms, we are able to automatically classify complaints, deviations, and non-compliance, ensuring that critical aspects are prioritized and handled quickly and appropriately.
The system can provide suggestions and classification proposals so that Quality Assurance professionals can quickly evaluate new quality factors, allowing higher productivity and intelligent decision-making. The second is automatic correlation: we can also exploit AI capabilities to garner insight into quality data. The system identifies and correlates events of similar quality to assist in subsequent improvement actions.”

These principles are at the foundation of the Digital QMS TrackWise System, which is the Sparta System proposal for Pharma companies. “TrackWise Digital is built on Saleforce.com, a PaaS platform (Platform-as-a-Service) which consists of an integrated suite of quality functionality (QMS as properly named), including complaints, supplier quality management (SQM), documentation management and training management (DMS, TMS),” adds Maniglio.

“TrackWise Digital was built on the back of over 25 years of quality management experience at Sparta Systems and is a scalable, flexible pre-configurated based on recognised industry standards. It is the first QMS in this industry to have decision-making capabilities enhanced by artificial intelligence. The assured benefits of this type of product are many. One of our clients companies, for example, wished to implement efficient, effective and consistent quality processes across multiple business sites around the world to improve customer response capacity and reduce warranty costs: with TrackWise Digital it has been able to internationally harmonize its quality processes based on industry standards and to take advantage of advanced reporting capabilities to demonstrate regulatory compliance, and improve overall quality processes, so improving the operational efficiency too.”

Lean Lab lands in Turkey!

First exclusive international release of the event created by LifeBee, dedicated to laboratories, for a selected audience of pharmaceutical industries. With Raffaella Vaiani, Teresa Minero and Karim El Sayed who shared experiences and lessons learned about Pharma 4.0, digital road map, lean, data integrity and compliance in QC and R&D laboratories.

Thanks to CONVAL group and Timur Kabadayı for the organizational support.

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