ARCONDIS UPDATE No. 02|2019: The smarter solution

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10_The smarter solution Glossary 4.0 – The term ‘4.0’ stands for the Fourth Industrial Revolution, as the digitalization has been dubbed across industries. Digitalization refers to digital technologies (such as the Internet of Things, big data etc.) that bring about and drive the development of change in the form of new processes and equipment (e.g. 3D printing). Digital transformation describes the consequences and effects of digitalization, i.e. the ways in which we shape our digital future. How do companies and individuals need to change and adapt? Which strategies and decisions will allow you to take maximum advantage of the opportunities inherent to digitalization and bring about positive change for all parties involved? Life Sciences 4.1 – ARCONDIS uses this term to describe the digital transformation in the specific context of the life sciences industry and its very particular regulatory requirements. Conventional approaches tend to encounter obstacles early on, and specialized industry knowledge is the only key to success. Experience has taught us that heterogeneous data structures often constitute an obstacle that requires realignment. As a general maxim: the better all fundamentals are positioned, the more effective your digital transformation will be. Fields of action: it’s all about purpose Practical applications that yield measurable benefits can normally be divided into four categories. The field of the digital workplace usually experiences the greatest extent of digitalization first. Many technologies, from cloud to collaborative applications, have made work processes more efficient already, and there is plenty of clear potential left. The digitalization of customer engagement can bring about new opportunities for communicating directly with patients, physicians … and collecting their valuable data (e.g. requirements or experiences of use). This facilitates product optimization. Process automation has been causing a genuine revolution in the life sciences and beyond. This includes new production methods, such as 3D printing and fully automated production processes based on PAT (process analytical technology), which often produce very personalized results. In many cases, all these applications bring about entirely new value creation chains or even business models, as new and agile players radically use new technologies and take the market by storm, new market requirements are detected or physical products are paired with digital services. Despite certain dependencies, various fields within companies use the new technologies in extremely different ways. Some apply them from the top down, implementing a whole new business model with an integrated patient engagement system, a process automation scheme or a digital workplace solution. Others optimize from the bottom up, focusing on the value creation processes that offer the greatest short-term potential and implementing a digital workplace right away. Island solutions vs. roadmaps Approaches to the digital transformation are frequently determined by the envisioned benefit: while concrete, business-driven projects in the fields of digital workplaces or process automation necessitate a pragmatic or even isolated approach, the optimization of customer engagement or, of course, the business model itself requires fundamental strategic considerations. A straightforward process can ensure a suitable solution for each individual requirement: first, identify and evaluate which potentials the digital transformation holds for your business. Then, substantiate individual use cases and determine strategy. Finally, produce a digital transformation roadmap. Wherever you intend to start, ARCONDIS will be by your side as a reliable and experienced partner. We focus on your gains in the digital transformation to ‘Life Sciences 4.1’. The fact that we are meeting this claim is evidenced by the high number of over 135 major and medium-sized life science companies for whom we have realized innovative projects for nearly two decades. We stand for good digital transformation practice. Stefan Eckert
Jenny über ... Weshalb GMP nicht auf „doppelt hält besser“ setzt Jenny about ... Why two eyes are enough for the GMP Kolumne / Column D_In vielen Branchen hat sich das sogenannte Vier-Augen-Prinzip sowohl zur Vermeidung von Fehlern als auch zum Schutz vor Betrug etabliert. Die Good Manufacturing Practice (GMP) wählt hier aber einen anderen Weg. Mit dem stark ausgebauten Instrument der Qualifizierung von Anlagen und Räumen sowie der Validierung von Software und Prozessen kann die Notwendigkeit der Doppelkontrolle im Idealfall gänzlich entfallen. Validierung und Qualifizierung ersetzen sozusagen das „zweite Augenpaar“. Die GMPRichtlinien fordern Kontrollen nach dem VierAugenPrinzip deshalb nur gezielt an wenigen Punkten, den sogenannten „kritischen“ Prozessschritten, die rein manuell durchgeführt werden müssen. Eine klassische Tätigkeit dieser Art ist die Kontrolle von Gewicht und Identität von Ausgangsstoffen – insbesondere von Wirkstoffen – beim Zusammenstellen der Rezeptur. Doch auch andere Prozesskriterien wie Temperatur, Druck, Zeitdauer oder Anlagenparameter können von so grosser Bedeutung für das Produkt sein, dass in den Vorschriften eine dokumentierte und damit nachweisbare Doppelkontrolle verlangt wird. Was heisst das aber für die Praxis der GMP? Das, was immer gefordert ist: die Analyse des Prozesses und ein entsprechendes Design von Abläufen, Vorgaben und Nachweisen. Es kann sinnvoll sein, das Einwiegen von Stoffen von zwei Personen vornehmen zu lassen. Alternativ kann man aber auch einen Drucker an die Waage anschliessen, der einen Beleg ausdruckt. Dann dient eben dieser Beleg als das zweite Augenpaar. Was aber nicht sein darf, ist das gedankenlose Einfügen von Kontrollschritten in die Abläufe. Ich erinnere mich an einen Fall, bei dem morgens um drei Uhr die Temperatur des Rührkessels vom Schichtmitarbeiter abgelesen und im Herstellprotokoll aufgezeichnet wurde. So weit, so gut. Doch im Protokoll war an dieser Stelle zusätzlich das Visum der Qualitätskontrolle vorgeschrieben. Dies erfolgte immer erst später durch eine Person, die bei der Temperaturablesung nota bene gar nicht anwesend sein musste – insgesamt aus GMPSicht ein komplett sinnloser Vorgang. Doppelkontrollen müssen immer plausibel und notwendig sein. Unsinnige Doppelunterschriften hingegen sind zu vermeiden, weil sie nicht nur keine zusätzliche Sicherheit bieten, sondern im Gegenteil sogar schaden. Es entstehen dadurch nicht nur Kosten und Aufwand, sondern es entwertet gleichzeitig das Instrument der Qualifizierung und Validierung. Als Prozessverantwortliche sagen Sie damit entweder „Wir misstrauen unseren Mitarbeitenden“ oder „Wir misstrauen der Validierung/Qualifizierung“ – beides definitiv nicht Ausdruck von „guter Praxis“. English E_The four-eyes principle has become a wellestablished requirement in many industries. It is intended to prevent both error and fraud. The Good Manufacturing Practice (GMP) has chosen a different approach. In the best case, the well-developed instruments of system and room qualification and the validation of software and processes make second-level approval unnecessary. The validation and qualification essentially replace the second pair of eyes. That is why the GMP guidelines only require the four-eyes principle in very few, specific aspects: the ‘critical’ process steps that must be carried out manually. This includes typically controls of the weight and identity of source materials and especially active substances during compounding. But there are other process criteria – temperature, pressure, duration, system parameters – that can be so important to the product that the regulations demand a documented, demonstrable four-eyes check. What does this mean for GMP in practice? The same requirements as always: a process analysis and the corresponding design of processes, specifications and recording. It can be useful to have two people weigh substances. Alternatively, a printer connected to the scales can print a document of evidence. In that case, the document replaces the second pair of eyes. What is unacceptable, however, is the thoughtless incorporation of additional control steps into the processes. I remember a case where a shift worker had to read the temperature of the stirrer tank at three o’clock in the morning and document it in the batch record. So far, so good. But the protocol also prescribed a second signature of this entry by a quality control officer. This step was carried out later by a person that did not even need to be present when the temperature reading was taken. From a GMP perspective, this sequence was completely pointless. Dual controls must be feasible and necessary. Nonsensical double signatures ought to be avoided: not only do they offer no additional security, they are a security risk. Besides the additional cost and effort involved, dual checks devalue the status of qualification and validation. As a process owner you either convey distrust in your employees or in the validation/qualification status. Neither is an expression of good practice. Als ehemaliger stv. Direktor der Swissmedic ist Dr. Hans-Beat Jenny Experte in Sachen GxP und verfügt über jahrzehntelange Branchenerfahrung. Der promovierte Chemiker war lange Zeit in Forschung und Qualitätssicherung eines Basler Pharmakonzerns tätig, bevor er die Leitung des Heilmittelinspektorats der Nordwestschweiz und später den Bereich Bewilligungen in der Swissmedic übernahm. Seit seiner Pensionierung im Jahr 2016 ist Jenny als Berater tätig. „Validierung und Qualifizierung ersetzen das zweite Augenpaar.“ “Validation and qualification essentially replace the second pair of eyes.” As a former Deputy Director of Swissmedic, Dr. Hans-Beat Jenny is an expert on GxP matters and has decades of industry experience. For a long time, the chemist with a doctorate degree had been involved in the research and quality assurance of a Basel pharmaceutical company, before taking over management of the Drug Inspection Agency of Northwestern Switzerland and later the Sector Licensing of Swissmedic. Jenny has been working as a consultant since his retirement in 2016.
Page 1 and 2: ARCONDIS NEWS No 2 | 2019 The smart
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Page 16 and 17: INSIDE Neuigkeiten aus der ARCONDIS
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