Think. Work. Integrate.


(Managing Director, Pitzek GMP Consulting)

about changes in the pharmaceutical industry

“A system must be valid”

Increasing requirements in the pharmaceutical industry also pose new challenges for GMP consulting. Managing Director Dirk Leutz from Pitzek GMP Consulting explains current developments and trends in an interview.

P+F: A provocative question: Why GMP consulting at all? Why is it necessary? What is the need for it?
Dirk Leutz: We advise customers on all aspects of GMP in many areas. This starts with a feasibility study through to the validation of a system, whether for manufacturers, plant constructors or other suppliers. GMP transparently regulates the handling of such projects over the entire life cycle of a product or system. That is the justification for GMP.

P+F: Because these regulations are so complex that they cannot be fully understood by the individual operator, so you need specialist knowledge of these regulations?
Leutz: There are various reasons for engaging our GMP heroes. On the one hand, our customers are grateful to have a partner who is familiar with the latest technology on the market, the regulations and has contacts to strong suppliers. On the other hand, the customer has the expertise, but not the necessary resources. Another reason for working with consultants is that our project managers structure different trades with complex tasks in a targeted manner and successfully bring them together in accordance with the regulations.

P+F: Is it just a question of specialist knowledge of the regulations and necessary steps, or is it also about additional security?
Leutz: It certainly makes sense to have a partner at eye level who actively supports you in the process. At the end of the day, the operator is responsible for the result and naturally also ensures that we provide the required service.

P+F: Can long-term trends in the industry be recognised behind the upheavals of the pandemic period?
Leutz: In terms of project management, the requirement for our employees to be constantly present on site has fallen to a healthy level.
We are also noticing that some customers are more hesitant to place orders and are focussing more on budget and delivering the promised service.
Some topics that used to be commissioned to accompany a project are now being scrutinised more closely, or we are being asked to present alternatives. We are happy to take on this challenge and allow ourselves to be measured against the promised services.

P+F: What new interests of the operators and what corresponding services have emerged from these changes?
Leutz: Comprehensive services that are handled in a focussed manner with clear communication and the tools of a project manager in the interests of the project. On the one hand, the area of automation has been added for us. The desire for automation is not new, but its implementation is becoming increasingly popular. On the other hand, we have expanded our portfolio to include QMS. This enables us to help our customers set up their quality management system (QMS). This is an exciting and diverse area in which we are confident and able to help our customers. We believe that strong expertise is not available everywhere, especially in the areas of automation and QMS. For example, we advise and support customers during upcoming audits and provide support so that they are well prepared for an audit appointment.

P+F: With these extensions, will operators soon have a complete solution from a single source?
Leutz: We are strongly focussed on the core processes of the pharmaceutical, food and biotech industries; building and air conditioning technology or architecture are not our core areas. For these areas, we have competent partners with whom we work and whom we trust, while remaining true to our competences.

P+F: Can automation and artificial intelligence be a solution to the skills shortage?
Leutz: Automation and AI can replace labour, but these are not independent processes, because if a robot is to take over activities that were previously carried out by humans, there will be someone who has to look after these robots. As a result, the qualifications required are increasing and the demands on skilled labour are becoming even higher.
Artificial intelligence will become more and more prevalent, and we cannot and should not deny this. But it will be some time before AI is actually used in a process. The requirement in our industry is always that a system must be valid. Until I can prove this with sufficient accuracy, AI will not be used. A current example of the use of AI is checking documents or document sets for completeness, for example in validation and qualification runs or simulating processes using complex data sets.

P+F: How are you dealing with the changes in the labour market in recent years?
Leutz: We are facing up to the challenges of today’s world and maintaining values that we are not throwing overboard. We try to create a good mix from this. Employees are demanding more flexibility and alternative working models such as remote work and working from home. However, we also say that the quality of our work must constantly improve. If this can be achieved with new models and ways of thinking, that’s great, but if not, we may have to use conservative methods to help ourselves. The pandemic has forced changes in this respect, but has also shown that it can be done without compromising quality. This has accelerated more or less unavoidable changes.

P+F: If these new working models make a lot of things possible remotely – how does that fit in with Pitzek’s company motto, “GENIAL LOCAL”?
Leutz: It fits together very well. We are with the customer when it is important and right for the project, otherwise we are always close by and ready to drop by, even if it’s just for a quick chat and nothing is concrete at first.

The questions were asked by Ansgar Kretschmer, Editorial Office Pharma+Food.

About the person:
Dirk Leutz is a trained brewer and maltster and has a degree in food technology. With professional experience in the fields of aseptics, plant engineering and process engineering, he took over the management of Pitzek GMP Consulting in 2021. He describes himself as a “down-to-earth mentor”.