News Archive | Experts Institut

Die wichtigsten GMP-Erkenntnisse 2025 und Prognosen für 2026

Die regulatorischen Anforderungen im GMP-Umfeld haben sich in den letzten Jahren spürbar verändert. 2025 zeigt sich deutlicher denn je: Es reicht nicht mehr aus, Vorgaben formal zu erfüllen. Behörden erwarten nachvollziehbare Entscheidungen, stabile Prozesse und eine Qualität, die im Arbeitsalltag tatsächlich gelebt wird. Für viele Unternehmen bedeutet das ein grundlegendes organisatorisches, technisches und kulturelles Umdenken.

GMP wird zunehmend als integriertes System verstanden, in dem Prozesse, Menschen, Daten und Technik eng miteinander verzahnt sind. Einzelmaßnahmen oder isolierte Korrekturen reichen nicht aus, um langfristig auditsicher zu bleiben.

Von Dokumentation zu gelebter GMP-Compliance

Inspektionen und Audits fokussieren sich zunehmend darauf, wie Qualitätssysteme im Tagesgeschäft tatsächlich funktionieren. Abweichungsmanagement, Change Control und CAPA-Prozesse werden nicht mehr isoliert betrachtet, sondern im Zusammenhang mit Verantwortlichkeiten, Schnittstellen, Eskalationswegen und Entscheidungslogiken.

2025 hat gezeigt, dass Inspektor*innen verstärkt hinterfragen, wer Entscheidungen trifft, auf welcher fachlichen Grundlage diese erfolgen und wie konsistent sie umgesetzt werden. Prozesse, die auf dem Papier schlüssig erscheinen, im Alltag aber unterschiedlich interpretiert oder angewendet werden, rücken schnell in den Fokus.

Ein zentrales Learning: Konsistenz ist ein entscheidender GMP-Faktor. Unterschiede zwischen Schichten, Standorten oder Verantwortungsbereichen werden zunehmend als systemisches Risiko bewertet. Insbesondere dann, wenn sie nicht erkannt, bewertet oder begründet werden.

CAPA, Change Control und Abweichungen im Kontext betrachtet

Aktuelle FDA-Warning Letters machen deutlich, dass eine rein formale Abarbeitung von Abweichungen und CAPA-Maßnahmen nicht mehr akzeptiert wird. Besonders kritisch bewertet die FDA das sogenannte „Testen bis zur Konformität“, bei dem Prüfungen wiederholt werden, ohne die eigentliche Ursache eines Problems zu identifizieren und nachhaltig zu beheben.

Stattdessen erwartet die FDA belastbare Ursachenanalysen mit erweitertem Blick: betroffene und angrenzende Chargen, vergleichbare Produkte, gemeinsam genutzte Anlagen sowie historische Trends müssen systematisch einbezogen werden. Ebenso wird eine nachvollziehbare Wirksamkeitsprüfung der CAPA-Maßnahmen eingefordert.

Bei hohen oder nicht akzeptablen Risiken sind zeitnahe und sichtbare Maßnahmen erforderlich. Verzögerungen – selbst wenn sie später korrigiert werden – schwächen aus Sicht der FDA das Vertrauen in das Qualitätssystem. Gleichzeitig rückt die Verantwortung von Qualitätseinheit und Management stärker in den Fokus: Wirksame CAPA setzen aktives Quality Oversight, kontinuierliche Trendanalysen und klare Entscheidungswege voraus.

Datenintegrität bleibt ein kritischer Prüfpunkt

Datenintegrität ist weiterhin eines der sensibelsten Themen im GMP-Umfeld – und 2025 hat diese Entwicklung nochmals verschärft. Behörden achten verstärkt auf vollständige Audit Trails, konsistente Datenflüsse, klare Rollen- und Zugriffskonzepte sowie auf den Umgang mit Ausnahmen und manuellen Eingriffen.

Auffällig ist, dass Datenintegrität zunehmend nicht nur als IT-Thema, sondern als organisationsübergreifende Aufgabe verstanden wird. Schulung, Bewusstsein und Führung spielen dabei eine ebenso große Rolle wie technische Kontrollen.

Technik, Prozesse und Qualitätseinheiten im Zusammenspiel

Technische Schwachstellen – etwa in der Anlagenqualifizierung, Wartung, Reinigung oder im Monitoring – führen weiterhin häufig zu Beanstandungen. Entscheidend ist jedoch immer seltener der einzelne Mangel, sondern die Frage, wie systematisch Unternehmen mit solchen Themen umgehen.

2025 wurde deutlich: Behörden bewerten stärker, ob Prozesse verstanden, überwacht und kontinuierlich verbessert werden oder ob lediglich auf Abweichungen reagiert wird. Ein reaktiver Ansatz gilt zunehmend als unzureichend.

Parallel dazu rückt die Rolle der Qualitätseinheit stärker in den Mittelpunkt. Qualitätseinheiten werden nicht mehr primär als Freigabestelle gesehen, sondern als aktive Steuerungs- und Überwachungseinheit. Erwartet werden fachliche Tiefe, Entscheidungsstärke und die Fähigkeit, Risiken klar zu adressieren – auch gegenüber operativen Bereichen.

Lessons Learned 2025: Wiederkehrende Muster aus Audits

Über viele Audits hinweg lassen sich für 2025 einige übergreifende Erkenntnisse festhalten:

Unklare Verantwortlichkeiten sind ein häufiger Ausgangspunkt für GMP-Abweichungen
Entscheidungen ohne dokumentierte fachliche Begründung werden zunehmend hinterfragt
Schulung allein reicht nicht aus, Anwendung und Verständnis zählen
Qualitätssysteme müssen als Ganzes funktionieren, nicht nur in einzelnen Modulen

Unternehmen, die diese Muster frühzeitig erkennen und adressieren, sind deutlich besser aufgestellt als solche, die nur punktuell reagieren.

Ausblick: GMP wird 2026 noch digitaler, risikobasierter und vernetzter

Mit Blick auf 2026 ist davon auszugehen, dass sich diese Entwicklungen weiter verstärken. GMP-Praxis bewegt sich klar in Richtung:

stärker integrierter digitaler Qualitätssysteme
datenbasierter Trendanalysen und Kennzahlen
vorausschauender Qualitätssicherung statt reiner Fehlerkorrektur

Risikobasierte Ansätze sind endgültig kein „Nice to have“ mehr, sondern regulatorischer Standard. Gleichzeitig steigen die Anforderungen an Transparenz, Nachvollziehbarkeit und Systemverständnis, insbesondere bei komplexen Herstellprozessen, Biologika und neuartigen Therapien.

Unternehmen, die ihre GMP-Organisation heute ganzheitlich ausrichten, schaffen nicht nur Auditsicherheit, sondern auch langfristige Stabilität in einem zunehmend komplexen regulatorischen Umfeld.

Wie das Experts Institut Sie unterstützt

Wir begleiten Unternehmen entlang des gesamten GMP-Lebenszyklus: von GMP-Assessments und Audit-Vorbereitungen über Hands-on-Support in Projekten, Interim-Management bis hin zu praxisnahen Schulungen für Fach- und Führungskräfte. Unser Fokus liegt dabei stets auf umsetzbaren Lösungen, regulatorischer Sicherheit und einer Qualität, die im Alltag funktioniert.

Unser Anspruch: GMP-Compliance, die nicht nur auf dem Papier besteht, sondern Audits standhält und Prozesse nachhaltig stärkt. Kontaktieren Sie uns, wenn Sie Ihre GMP-Organisation zukunftssicher aufstellen möchten. Get ahead and in touch with us – info@expertsinstitut.de

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1 Monat /von Christoph Köth

GMP, News

GMP Guidance for Artificial Intelligence (AI), Machine Learning (ML) and Digital Transformation: How it Finally Begins to Enter the EU GMP Guide

The Now: Gaping Holes

When sifting through today´s status of the EU GMP Guide, it does not take an expert to see that there are gaping holes on topics of engineering, management of computerized systems, data integrity, digitalization and application of artificial intelligence.

Not that the guide has nothing to say to some of these areas. At least by means of implication the guide says lots of things between the lines. This very “in-between” is what gives pharmaceutical manufacturers quite a headache when facing governmental inspections.

The issue is that what it has to say does not cover what´s actually out there. And “by implication” is simply not a good advisor for the industry. It may be good enough for an inspector to set up interpretive requirements and for giving industry a hard time. But for a company it is simply not practicable when a text is elusive.

Although we have best practices like ISPE GAMP5 or other guidance somewhere out in the GxP universe, we would like to know from our most relevant guide-the EU GMP Guide-what is required. And this very guide has been doing a rather horrible job to provide the input industry needs (it seems not surprising that some EU countries struggle massively to keep life sciences and pharmaceuticals on their territory).

A New Hope

A new hope may be on the horizon as we have been expecting a revised version of Annex 11. There-so tells us the concept paper-we will receive a text that will address words such as artificial intelligence, clouds, and even digital transformation. One might wonder whether it is worth holding our breath for the release of the new Annex 11, as high hopes have been shown to greatly disappoint before. One might remember Annex 21 or interpretive documents from local supervizing authorities, that in the end have not been helpful for real life at all.

However, in this case it may be different. Can we guess some consequences from this next generation Annex 11?

GMP Data Integrity Finally Takes Center Stage

Although some would passionately disagree with me on this, the EU GMP guide has virtually lacked clarity on data integrity for decades. It was the US FDA who had to essentially teach us in Europe what Data Integrity is and why this is important. Without them we would still think that Good Documentation Practices and Validation of Spreadsheets is all it takes.

I love how every EU member state GMP inspector knows exactly what is necessary in terms of data integrity-only with next to no express textual basis for it in the EU GMP guide. I mean sure: evey company has by now heard of data integrity, letalone has received inspections that dealt with it. And yes, we were told after the fact that the GMP guide has “always meant” data integrity in various little phrases of the guide. But that seemed a bit of a crutch to assure the colleagues from US FDA that in Europe data integrity is something we “totally want and require!”

Point taken, it is true that in the Annex 11 we had such wording in some spots. And now the EU guide will finally take into consideration the fuller importance of data integrity-at least for computerized systems. One can tell that the EU grows more toward considering guidance from for example WHO or PIC/S.

The consequences will be that audit trails and audit trail review requirements will be clarified and likely deepend. More work. The bar for what is “basic” will be raised.

The same will happen for archiving, backups, and retrieval requirements for archived data. Companies will unlikely be able to keep playing the low-key game in the archiving area.

Management of Clouds will be a Topic

This will be upgraded, or actually decently considered in the new Annex 11. And here I must say that this is positive improvement. The GMP guide has been pretty much blind to this for quite some time now. It will be a reasonable change. It will be interesting to see how block-chain systems will be treated under the new Annex 11.

And I certainly will be interested to see how cloud hosts seriously validate and qualify their systems, software, and infrastructure. The hunsh is: this is going to cause trouble for some service providers. My recommendation to cloud providers who have pharma-clients: Get ready for it now, or You will be out of business before You know it.

If this enters Annex 11 it could mean:

– cloud services must qualify their infrastructure according GMP.

– they must validate their software fully in line with GMP as well.

This essentially would require a quality-oriented quality management system (and no, ISO9001 would not suffice, not the slightest chance for anyone who wants to take this seriously).

GMP for Artificial Intelligence (AI) and Machine Learning (ML) will Hatch

We must be honest here: it might not be a whole lot of guidance what we will receive from the revised Annex 11:

The primary focus should be on the relevance, adequacy and integrity of the data used to test these models with, and on the results (metrics) from such testing, rather that on the process of selecting, training and optimising the models.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products-computerised-systems_en.pdf

Though this quote from the concept paper is as elusive as sand running through one´s fingers, it does give us a tiny insight in what will be important to a regulator or a GMP-inspector: data (and their quality) used to feed AI models.

One of the biggest questions is: How in the world do we validate AI and ML? Will AI or ML need to be validated according to the typical V-model? In reality this seems almost impssible, since any software code change would required re-validation. And code changes might have to be expected, especially with machine learning. My assupmtion is that we will not receive much help here form the new Annex 11. Industry will be thrown back on non-governmental best practice guidance-as is often the case.

“No New Requirements”

It must be acknowledged that some of what we will find in the revised Annex 11 will likely be clarification and nailing down of requirements that were logical consequences from what is in the current version of the Annex. Yet, we will also find more work, new requirements.

For each company a careful gap assessment will be in order, and for those who have gotten away with mediocre management of electronic systems it will be time to act and invest in modernization.

Needless to say, that I am already looking forward to the next years at Experts Institut, when those projects will continue to fill our work schedules. It is a great challenge!

GMP Challenges for Small Pharmaceutical Businesses

I encourage representatives of small businesses – smaller pharmaceutical entities – to comment and to give feedback once the draft to the new Annex 11 is out. Often it is the larger pharmaceutical businesses that drive or influence what best practice is or what those texts may contain. A consequence can be that the requirements push smaller companies off the cliff of financial and infrastructural fesability. This does not need to be so. But small businesses must take a bit of a stand here. Take the chances You get, that is my recommendation. Digitalization and the use of AI and ML are unstoppable because neither society and nor the economy will not stop it. This is coming at the industry real fast. And it will likely make or break smaller business in the near future. Thus – get ahead with it!

Experts Institut can help!

Need help with GMP-Digitalization projects and AI-validation concepts? Contact us. Management consultancy GMP, GXP & Business Solutions | Experts Institut (experts-institut.com ).

Read our full blog: https://experts-institut.de/newsroom/

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23. Oktober 2024/von Dr. rer. nat. Dietmar Gross

GMP, GXP, News

GMP and Digitalization: Some basic thoughts

It is almost 8.00 am, we are standing on front of a building which houses an officially GMP-accredited contract laboratory service. Our task for today: carry out a full blown GMP-audit on the contract lab.

On the inside I am a bit excited. Because I know that in each audit I do not only evaluate others, but I will also gain and learn! And each auditee – be it a laboratory, a GMP-manufacturer or a material supplier (API, excipients, packaging materials) is different, and each uses different ways and systems to implement GMP. So far so good.

Later that day the audit is over and my co-auditor and I we feel overall happy with the audit. Still – we also feel disillusioned: we had expected a more modern way of raw data, data and document management. What did we find? An almost 100% paper-based GMP- and data management system, with all its nicks and dents when it comes to the GMP such a system can provide – it is alright, but it no doubt has limits.

Fully paper-based – that something like this still exists? And that in a GMP-bound establishment? It sure does still exist.

In the GMP-Universe the Digitization Truck has departed, but by far not delivered to all yet!

In our line of work at Experts Institut, we are often surprised by how many companies in the drug manufacturing, medical device, and cosmetic GMP areas operate with a very low degree of digitalization in their processes and data management. This observation grounds everyone and reminds us that digitization is not as advanced in the regulated industry as we might like to believe. Despite being a socio-economic and political desire among regulators and industry, progress is still lacking. In fact though, it is not(!) a given, it is not a self-propagating realization all over the place. And this does not only concern small companies who seem to just not be able to finance the digital transformation. It also concerns for example medium-size GxP-entities. If You think that the size of a company is an indicator for its degree of digitalization then You need to think again. There is no such connection. You´d be surprised what we encounter in our daily work.

Even politics, cultural Western optimism and the strong drive to achieve and constantly change toward something new is not always the recipe for producing a digital revolution by and large.

Incentives for change must come from the market, it must be attractive, plausible to implement and at reasonable cost. And in a highly regulated area like the white industry (Pharmaceutical GMP, Medical Device Quality Assurance, Cosmetic-Industry) New means not only Opportunity, but also Risk. And in white industry products the Risk is considerable. An excellent example is the timidity of the GxP-industry to enter continuous manufacturing transformation – for a lack of experience with the regulators in this area. A similar reason may be at the root of the spotty coverage of digitalization.

Concerns and Opportunities of Digitalization for GxP Establishments

Some companies shy away from larger transformations due to finances thin-stretched. And due to a blurred understanding where then the actual benefit of digital data- and process-management really hit home positively.

Others simply do not see any need to change and keep up with modernization. Because for a period of time resisting change can go without noticing any consequences in the business numbers and balances. Even in terms of basic GMP-systems quite a few companies are chronically underfinanced.

Again others are apprehensive about the risk that may come to their data and company information due to migrating eveything into electronic formats, networks and clouds – and that is a very understandable risk. There are solutions to protect data from even the most sphisticated attacks, but they will cost.

Looking at the opportunities: once digitalization has reached a company´s operative processes – where product is actually made (not just where warehousing and document management are electronic) – a company has arrived on a temporary plateau of readiness for tomorrow.

And here is the thing: that readiness will likely make or break any business eventually – but most certainly a GMP-business!

You will need digitalized company processes (manufacturing, analytics, logistics, quality management, compliance, engineering and technical systems) and data management to be ready for:

a globalized approach in making business wich data, knowledge and information sharing at the top (regulatory submission, block chain approaches for decentralized data management),
adapting to constantly advancing regulatory standards for GMP-data management and managing modern technologies in development and even in routine production (see for examples EU GMP Guide Annex 1),
the time when advanced and continuous manufacturing becomes more and more established (and this is already happening),
advancing cost efficiency concerning staff Your system would otherwise require to cater to the massive burden of GMP-/GxP-requirements.

Where to start? And how to get on the Truck?

Digitalization in a GMP-/ GxP-liable company typically follows some sort of evolutionary model.

Basic for any company is to have at least material management systems, warehousing and logistics managed by electronic systems. At least for article data and inventory as well as location and status management such systems are standard. This is nothing new of course. But I tell You: there are in fact some companies that don´t have even that.
The second layer often is electronic Document Management (eDMS).
Then comes electronic batch record – at least partially, more often electronic deviation and change management or other QM subsystems – mostly non-integrated but separate applications.
and then – typically – a full electronic Quality Management System, some commpanies using the opportunitydigitizing their business and administrative processes if they haven´t so yet.
Global companies need to deal with additional issues with data sharing and data security across the corporation, leading to for example decentralized data storage solutions for example controlled via block chain technology.
And by the latest at that point comes the phase of trying to integrate all of this.

Basic Evolutionary Degress of Digitalization in GMP and GxP-liable Companies (pharmaceutical manufacturing and on-coming suppliers, medical devices industry, cosmetics).

As You can see: if Your company is currently a low-digitized business – do not be dismayed. You may have just about missed out all those years where all the others have hustled and bustled to add one little digital island system after the other. And You now have the advantage to look back on this and make a decision to roll out digitalization compreheneively and for the first time!

Digitalization in a GMP-Environment

There are challenges of course. Digitalization cannot be rushed or it will result in a gigantic failure with data loss, loss of company spirit and – worst case – of good people who will quit over the frustration of the failed digitalization effort. Leadership will lose credibility and trust – which is worse than anything from a company perspective.

The more integrated You advance Your digitalization the more keeping in with the validated state is a true GMP-challenge. And a huge caveat I must place here is: Be very thorough when working with validation-packages from software suppliers! They come from a non-GMP quality system environment. Often no QMS around the software development at all. And so You need to take charge of what is done concerning validation (initial, updates, integration and post-integration management) – even and especially when it is an ISPE GAMP®5 category 3 or category 4 system. And do not mistake brand names for assurance of GMP-compliance. Our audit practice shows that even systems which ar heavily advertized for can lack basic regulatory compliance requirements or are not fully compatible with local national GxP-requirements. (An issue that even electronic deviation workflows or eBR systems can have).

For some newer technologies (Blockchain Technology, Decentralized Data Management, AI / Machine Learning / Neuronal Networks) You must understand: regulatory agencies are yet to say and to judge what they require from the GxP-viewpoint, depending on each situation of digital integrated process landscaping and data generation and management. Of course You can apply the current GxP-regulations´ point to now. But it may not in all cases be what You need.

And take a good look where You will market Your products: some regulatory agencies are on high alert concerning data and processes in digitalized environments and close to publishing guidance, others are – yet – fast asleep but won´t be forever.

What We (EI) do when We support a company in digitalization or digital transformation?

We Support Your planning – Organization and Required Efforts:

Feasibility study, digitalization concept, regularoy GMP-/GxP- and cGMP compliance assessment, also of existing levels of digitalization.

EI prepares Your body of documents:

With You we estalish and review the required GxP-relevant document You will need for individual systems and for global structure concept papers and policies keeping in with Your data integrity and data security requirements.

We work with those from Your company who will live and operate the / in the system:

Coordinating a digitalization project can be challenging and requires a sober and coordinative mind and management skills. Often companies new in the arena of digitalization do not have personnel to carry such a project and coordinate all the stakeholders – on top of their daily workload. But we (EI) have people who can take such a mandate and help Your own people advance in knowledge and with the project alike.
We keep alliance with partners who can drive the actual digitalization of data. Especially if You find no suitable business counterpart for example doing power BI for data pooling structures and more.

What will it take Your company (with or without external help)?

If You do digitalization – especially if You take a larger step (no matter in what area in Your GMP-, GDP, or GxP-company), You might as well do it wholeheartedly.

It will take extra effort on the part of everyone involved, and this is a real extra – not just an imaginary thought. Prepare Your staff wisely! Communicate with credibility where this is going.
It will take a darn good project manager and project management structure that can react to the unforeseen.
It will take nerve – lots of nerve – to face how many things that used to be non-digitalized actually never really worked! This will cause delay.
It will take plausible timelines that are only to a limited degree tied to immediate business goals – for then if it (digitalization) delays or fails – then all fails!
And – most importnatly – it will take a change agent to generate acceptance of the things that are coming.

All things considered: be courageous and give it a go. In the long run there will likely be no way around a rather comprehensive digitalization for GxP-companies. Now is a good time.

Get ahead and in touch with us – info@expertsinstitut.de

Read our full blog: https://experts-institut.de/newsroom/

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28. März 2024/von Dr. rer. nat. Dietmar Gross

News

Zukunft Gestalten: KI als Schlüssel für fortschrittliche Unternehmensführung

Künstliche Intelligenz (KI)

Künstliche Intelligenz ist mehr als nur ein Schlagwort aus der Welt der Science-Fiction und Robotertechnik – sie ist eine tief in unseren Alltag integrierte Technologie. Als ein dynamisches und fortschrittliches Feld zielt die KI darauf ab, Systeme zu entwickeln, die in der Lage sind, Aufgaben zu erfüllen, die bislang dem menschlichen Verstand vorbehalten waren. Ob es um Algorithmen geht, die aus Erfahrungen lernen, oder um Systeme, die menschliche Sprache verstehen und darauf reagieren können, KI eröffnet neue Horizonte in der technologischen Entwicklung.

Sie verspricht, die Art und Weise, wie wir arbeiten und leben, durch die Optimierung von Prozessen, die Schaffung innovativer Lösungen und die Verbesserung der Effizienz grundlegend zu verändern. Darüber hinaus ermöglicht Künstliche Intelligenz eine natürlichere Interaktion zwischen Menschen und Maschinen durch die Entwicklung von intuitiven Benutzeroberflächen und Sprachassistenten, die unseren Alltag erleichtern. Mit ihrer Fähigkeit, Branchen von der Medizin bis zur Fertigung zu transformieren, hat sich KI von einem Konzept der fernen Zukunft zu einer gegenwärtigen Realität gewandelt, die die Geschäftswelt quer durch alle Sektoren revolutioniert.

Technologischer Fortschritt

Die Experts Institut Beratungs GmbH hat die transformative Kraft der Künstlichen Intelligenz frühzeitig erkannt. Unser Engagement für die Nutzung der KI-Technologie zielt darauf ab, unsere Betriebsabläufe zu optimieren, echte Herausforderungen zu meistern und substantiellen Mehrwert zu schaffen. Unsere Entscheidung, KI in unsere Arbeitsweise zu integrieren, ist von der Überzeugung getragen, dass technologischer Fortschritt unser Leben verbessern und effizientere sowie intelligentere Lösungen hervorbringen sollte.

KI-Technologie

Der Übergang zur KI-Technologie markiert für uns nicht nur einen technologischen Fortschritt, sondern ist Ausdruck unserer Verpflichtung gegenüber Kunden und Mitarbeitenden, eine bessere, funktionalere Zukunft zu gestalten. Diese strategische Ausrichtung beruht auf sorgfältiger Planung und dem Bekenntnis zu ethischen Grundsätzen und Nachhaltigkeit im Umgang mit KI.

Im Experts Institut sind wir mehr als ein Team – wir sind eine Gemeinschaft, die sich dem Ziel verschrieben hat, einen positiven Einfluss auf die Zukunft zu nehmen. Gemeinsam wollen wir die vielfältigen Möglichkeiten erkunden, die uns die Künstliche Intelligenz eröffnet, und so einen Weg in eine vielversprechende Zukunft ebnen.