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AI in the pharmaceutical industry: Annex 22 & EU AI Act – current obligations and practical implementation

The use of artificial intelligence (AI) is rapidly gaining importance in the pharmaceutical industry – from increasing efficiency in everyday office work to complex applications in GMP-relevant processes. At the same time, regulatory requirements are increasing significantly. The EU AI Act and the planned Annex 22 to the EU GMP guidelines will provide a clear regulatory framework for the use of AI in regulated environments for the first time.

This article summarizes the key content of the Experts Talk “AI in the pharmaceutical industry – Annex 22 & EU AI Act as a framework for quality and efficiency”, which took place on 27 November 2025. The discussion focused on what these regulatory developments mean in concrete terms for pharmaceutical companies, what obligations already apply today and how the path from risk analysis to regulatory compliance can be successful.

EU AI Act

Why the EU AI Act and Annex 22 are relevant now

The EU AI Act is the first comprehensive European regulation for the use of AI. It takes a risk-based approach and differentiates between AI applications according to their potential impact on people, safety and fundamental rights. The AI Act is particularly relevant for pharmaceutical companies, as many AI applications can be classified as high-risk.

At the same time, the planned Annex 22 specifies the authorities’ expectations for the use of AI in the GMP environment. Even though Annex 22 had not yet been finally adopted at the time of the Experts Talk, it was clear from the exchange with the speakers that the regulatory direction is clear – and companies should prepare now.

Annex 22 & EU AI Act at a glance: Which regulations apply to which AI use cases – from office chatbots to AI in the GMP process?

A central topic of the Experts Talk was the clear demarcation of the various regulations and their areas of application. This is because not every AI application is subject to the same requirements. The decisive factors are the context of use, risk potential and impact on product quality, patient safety and human rights.

Two sets of rules – two perspectives

  • EU AI Act: The EU AI Act is a horizontal, cross-sector regulation that addresses the use of AI throughout the entire company. It applies not only to GMP processes, but also to AI applications in HR, IT, office areas and management. The aim is to protect fundamental rights, safety and health and to create trust in AI systems.
  • Annex 22 (Draft): Annex 22 is a vertical, GMP-specific supplement to the EU GMP guideline. It focuses exclusively on AI applications in the regulated manufacturing environment and particularly addresses systems with an impact on product quality, patient safety and data integrity. The annex is strongly oriented towards GAMP 5 principles and supplements existing regulations such as Annex 11 and Chapter 4.

Typical AI use cases and their regulatory classification

1. office and support applications (low to minimal risk)
Examples:

  • Office chatbots for text creation or translation
  • Spelling and formulation aids
  • AI-supported ticket or document sorting

These applications generally have no direct influence on GMP decisions or patient safety. Nevertheless, there are already requirements arising from the EU AI Act, particularly with regard to:

  • Transparency about the use of AI
  • Employee training (AI literacy)
  • Clear internal rules on the use and handling of data

2. decision-supporting AI systems (limited to high risk)
Examples:

  • AI-based decision support in QA or production
  • Forecast models for maintenance, deviations or capacity planning

Regulatory requirements are increasing significantly here. Relevant factors include

  • Structured risk assessment and classification
  • Documentation of models, data basis and decision logics
  • Clear governance structures and responsibilities
  • Concepts for human control (human-in-the-loop)

The more decisions are automated or prepared, the closer these systems come to the high-risk area of the EU AI Act.

3. AI in the GMP core process (high risk / Annex 22 relevant)
Examples:

  • AI-supported process monitoring
  • Automated quality assessments
  • AI systems with influence on approval decisions

These applications are clearly the focus of Annex 22, as the draft makes clear:

  • Critical AI systems must be deterministic, validatable and explainable (XAI)
  • Dynamic learning systems and generative AI are not currently intended for critical GMP applications
  • Human-in-the-loop is absolutely essential
  • Data quality, traceability and life cycle documentation are key success factors

The Experts Talk clearly showed that the EU AI Act and Annex 22 are not alternatives, but complement each other. Companies must consider both perspectives in order to use AI in a compliant and sustainable manner.

What pharmaceutical companies already have to consider today

A key conclusion of the Experts Talk: waiting is not an option. Even without the final adoption of Annex 22, there are already specific requirements from existing GMP regulations, the EU AI Act and general quality assurance principles.

It was particularly emphasized that companies must obtain a structured overview of all AI applications used or planned. Regardless of whether these are used in the GMP core process, in supporting areas or in everyday office work.

The key requirements include in particular

  • Transparency and traceability of AI systems
  • Risk assessment and classification of AI use cases
  • Documentation and governance over the entire life cycle
  • Training and qualification of employees

Shadow AI poses a particular risk here – i.e. the uncontrolled use of generic AI tools such as ChatGPT in day-to-day work. Without clear rules, approvals, training and documentation, this can quickly lead to deviations and compliance risks.

Implementing AI governance in practice: Tool to support regulatory requirements

It became clear that regulatory requirements such as the EU AI Act, Annex 22 (Draft) and ISO/IEC 42001 can only be implemented effectively if they are translated into clear, practicable structures.

This is where an AI governance solution from Goodly Technologies comes in, which is currently being developed specifically for regulated industries. The tool supports companies in managing AI systems in a structured and traceable manner throughout their entire life cycle: from planning and deployment to continuous monitoring.

Among other things, the focus is on:

  • Systematic recording and classification of AI applications
  • Documentation of responsibilities, risks and controls
  • Illustration of key requirements from Annex 22
  • Integration of SOPs, training and proof of audit and inspection capability

The aim is not to limit AI, but to make it usable in a controlled manner as a basis for innovation and regulatory security. If you have any questions about the tool, please contact Robert Hoffmeister: robert.hoffmeister@goodly-technologies.com

Conclusion: Set the course for compliant AI now

The Experts Talk on November 27, 2025 made it clear that the EU AI Act and the planned Annex 22 are not abstract future topics, but are already having a concrete impact on the day-to-day work of pharmaceutical companies.

Companies that already use AI or are planning to use it should act early:

  • Identify AI use cases
  • Assess risks
  • Clarify responsibilities
  • Define processes
  • Train employees

Structured preparation makes it possible to use regulatory requirements not as a brake, but as a foundation for the safe, efficient and sustainable use of AI.

How the Experts Institute can support you

The Experts Institute supports pharmaceutical companies in the classification of regulatory requirements, the practical implementation of AI governance as well as training courses and workshops on the EU AI Act, Annex 22 and AI in the GMP environment. Get ahead and get in touch with us: info@expertsinstitut.de

The Experts Talk series will also be continued. The next Experts Talk will take place on January 22 at 10:30 a.m. on the topic of “Pharmaceutical-grade use of generative AI”. To register for the event:
https://academy.experts-institut.de/ExpertsTalkmitChristophKthRobertSpariPharmatauglicherEinsatzvongenerativerKI

You can find more articles in our newsroom:
https://experts-institut.de/newsroom/

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The most important GMP findings for 2025 and forecasts for 2026

The regulatory requirements in the GMP environment have changed noticeably in recent years. In 2025, it is clearer than ever that it is no longer enough to formally fulfill requirements. Authorities expect comprehensible decisions, stable processes and quality that is actually practiced in day-to-day work. For many companies, this means a fundamental organizational, technical and cultural rethink.

GMP is increasingly understood as an integrated system in which processes, people, data and technology are closely interlinked. Individual measures or isolated corrections are not enough to remain audit-proof in the long term.

GMP

From documentation to active GMP compliance

Inspections and audits are increasingly focusing on how quality systems actually function in day-to-day business. Deviation management, change control and CAPA processes are no longer viewed in isolation, but in the context of responsibilities, interfaces, escalation paths and decision-making logic.

2025 has shown that inspectors are increasingly questioning who makes decisions, on what professional basis they are made and how consistently they are implemented. Processes that appear conclusive on paper but are interpreted or applied differently in everyday life quickly come into focus.

A key learning: Consistency is a decisive GMP factor. Differences between shifts, locations or areas of responsibility are increasingly seen as a systemic risk. Especially if they are not recognized, evaluated or justified.

CAPA, change control and deviations considered in context

Current FDA warning letters make it clear that a purely formal processing of deviations and CAPA measures is no longer accepted. The FDA is particularly critical of so-called “testing to compliance”, in which tests are repeated without identifying the actual cause of a problem and eliminating it sustainably.

Instead, the FDA expects robust root cause analyses with a broader perspective: affected and adjacent batches, comparable products, shared facilities and historical trends must be systematically included. A comprehensible effectiveness test of the CAPA measures is also required.

Prompt and visible action is required when risks are high or unacceptable. Delays – even if they are corrected later – weaken confidence in the quality system from the FDA’s perspective. At the same time, there is a greater focus on the responsibility of the quality unit and management: effective CAPA requires active quality oversight, continuous trend analyses and clear decision-making processes.

Data integrity remains a critical checkpoint

Data integrity continues to be one of the most sensitive issues in the GMP environment – and 2025 has further intensified this development. Authorities are paying more attention to complete audit trails, consistent data flows, clear role and access concepts and the handling of exceptions and manual interventions.

It is striking that data integrity is increasingly understood not only as an IT issue, but as a cross-organizational task. Training, awareness and leadership play just as big a role as technical controls.

Technology, processes and quality units in interaction

Technical weaknesses – for example in system qualification, maintenance, cleaning or monitoring – continue to lead to frequent complaints. However, it is less and less the individual defect that is decisive, but rather the question of how systematically companies deal with such issues.

2025, it became clear that authorities are evaluating more closely whether processes are understood, monitored and continuously improved or whether they are merely reacting to deviations. A reactive approach is increasingly considered insufficient.

At the same time, the role of the quality unit is becoming more central. Quality units are no longer seen primarily as an approval office, but as an active control and monitoring unit. What is expected is technical depth, decision-making power and the ability to clearly address risks – also in relation to operational areas.

Lessons learned 2025: Recurring patterns from audits

Across many audits, a number of overarching findings can be identified for 2025:

  • Unclear responsibilities are a frequent starting point for GMP deviations
  • Decisions without documented professional justification are increasingly being questioned
  • Training alone is not enough, application and understanding count
  • Quality systems must function as a whole, not just in individual modules

Companies that recognize and address these patterns at an early stage are in a much better position than those that only react selectively.

Outlook: GMP will be even more digital, risk-based and networked in 2026

Looking ahead to 2026, it can be assumed that these developments will continue to intensify. GMP practice is clearly moving in this direction:

  • more integrated digital quality systems
  • Data-based trend analyses and key figures
  • Predictive quality assurance instead of pure error correction

Risk-based approaches are finally no longer a “nice to have”, but the regulatory standard. At the same time, the requirements for transparency, traceability and system understanding are increasing, especially for complex manufacturing processes, biologics and novel therapies.

Companies that take a holistic approach to their GMP organization today not only create audit security, but also long-term stability in an increasingly complex regulatory environment.

How the Experts Institute supports you

We support companies throughout the entire GMP life cycle: from GMP assessments and audit preparations to hands-on support in projects, interim management and practical training for specialists and managers. Our focus is always on practicable solutions, regulatory safety and quality that works in everyday life.

Our claim: GMP compliance that doesn’t just exist on paper, but withstands audits and strengthens processes in the long term. Contact us if you want to future-proof your GMP organization. Get ahead and in touch with us – info@expertsinstitut.de

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Mastering GMP audits successfully: What really matters

GMP audits are one of the key quality assurance tools in the pharmaceutical and life science industry. They check whether manufacturing processes, documentation, systems and working methods comply with regulatory requirements at all times. This is not just about compliance with formal requirements, but also about ensuring product safety, process stability and quality in practice. Successful GMP audits therefore make a significant contribution to patient safety, corporate risk minimization and a sustainable compliance culture.

GMP audits

Why GMP audits are of strategic importance

An audit is much more than just an inspection. It signals quality, transparency and a sense of responsibility towards customers, authorities and patients. Companies that establish audit stability as part of their organizational culture not only benefit from regulatory security, but also from better internal processes, clear responsibilities and increased efficiency. Findings are not a failure, but a valuable indicator for further development.

Audit preparation

Preparation for a GMP audit does not just begin in the days leading up to the date, but is part of continuous compliance management. An audit-compliant company is characterized by complete and up-to-date documentation, clear responsibilities, uniform standards and structured training and competence management. Internal communication is also an important building block: employees should understand why audits take place, what expectations exist and how they can communicate in a secure and fact-based manner. Many companies use internal mock audits or Q&A training to create security and practice typical situations in a realistic manner.

Audit implementation

During the audit, the focus is on clarity, traceability and integrity. Auditors not only evaluate documents and processes, but also the organization as a whole: Do employees know how processes work? Can decisions be explained? Is there a visible quality culture? Successful audit participants answer precisely, based on facts and only within their area of responsibility. Equally important is structured on-site support for the audit: a defined process, prepared rooms, clean accompanying documentation and professional communication support a positive result.

Follow-up

The phase after the audit determines the long-term benefit. Findings should be analyzed systematically and not viewed in isolation. Root cause analyses help to identify structural weaknesses instead of merely remedying symptoms. Action plans should be realistically scheduled, have clear responsibilities and then be checked for their effectiveness. This creates a learning system that continuously optimizes quality.

Typical audit risks and how companies can prevent them

In many GMP-regulated organizations, audit deviations are not caused by a lack of expertise, but by process gaps, inconsistent implementation and poor documentation quality. Common risk factors are:

– Incomplete, contradictory or outdated documents
– Process knowledge that only exists verbally (“tribal knowledge”)
– Lack of justification or risk considerations in decisions
– Training certificates without verifiable competence assessment
– Poor data integrity or unclear roles and responsibilities

An effective approach therefore does not lie in short-term “polishing up” before an audit, but in operational routine quality: processes must be designed in such a way that they are auditable at all times and are transparent, reproducible, risk-based and compliant with data integrity. Audit stability is achieved when documents reflect reality and reality is lived in accordance with the rules.

Support from the Experts Institute

We support companies in all audit phases, from the initial assessment to the implementation of practical mock audits and the sustainable implementation of corrections. Our work is practice-oriented, based on regulatory requirements and geared towards the individual level of maturity. In doing so, we pursue the goal of permanently anchoring audit stability and making quality tangible, comprehensible and measurable.

Conclusion: Audit strength comes from practiced quality

Successful GMP audits are no coincidence, but the result of a professional quality culture, clear responsibilities and continuous improvement. Companies that see audits as an opportunity rather than a burden strengthen their competitiveness, increase their compliance level and promote sustainable, process-oriented corporate development.

If you would like to increase your audit stability or develop your processes to the next level of maturity, we will be happy to support you. Get ahead and in touch with us – info@expertsinstitut.de

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Continuous manufacturing: future trend in the pharmaceutical industry

The pharmaceutical industry is at a turning point. For decades, traditional batch processes characterized the production of pharmaceuticals. Although these have proven their worth, today they are often considered rigid, slow and resource-intensive. Continuous manufacturing opens up a new path: production no longer takes place in individual batches, but continuously and without interruption. This not only changes the speed of production, but also the quality, flexibility and sustainability of pharmaceutical processes.

Continuous Manufacturing

What does continuous manufacturing mean?

In contrast to the traditional batch process, continuous manufacturing enables end-to-end production in a closed system. While intermediate storage and waiting times used to be unavoidable, continuous manufacturing allows for constant production and monitoring. As a result, companies benefit from shorter production times, consistent product quality and more efficient use of resources. At the same time, the technology makes it possible to react more flexibly to fluctuations in demand and avoid supply bottlenecks. Continuous manufacturing is therefore much more than a technological innovation; it represents a fundamental paradigm shift in the pharmaceutical industry.

Digitalization as a driver for process stability

The benefits of continuous manufacturing can only be exploited through consistent digital transformation. Modern sensor technology, Process Analytical Technology (PAT) and Advanced Process Control (APC) make it possible to monitor production processes in real time. This ensures process stability and deviations can be detected and corrected immediately. At the same time, end-to-end data acquisition ensures that quality information is seamlessly documented and integrated into regulatory systems. The result is not only stable and safe production, but also greater transparency with regard to GMP compliance.

Focus on regulatory requirements

The authorities have also recognized the potential. The FDA is considered a pioneer and has already granted the first approvals for continuous manufacturing processes. In Europe, the EMA is also taking a closer look at the topic. For companies, this means that investing in continuous manufacturing at an early stage not only makes it easier to obtain approval later on, but also puts them in a strategic position with regard to future inspections. Pilot projects are a valuable way of gaining experience and taking regulatory expectations into account from the outset.

Impact on supply chains and sustainability

An often underestimated aspect of continuous manufacturing is its contribution to sustainability. Reduced energy and material consumption results in less waste. At the same time, continuous production enables production “on demand”, which reduces stock levels and makes medicines available more quickly. Continuous manufacturing therefore offers a decisive advantage, particularly in crisis situations or in the event of supply bottlenecks. For the global supply chains of pharmaceutical companies, this means greater flexibility, shorter response times and overall greater security of supply.

Challenges on the road to implementation

Of course, the switch to continuous manufacturing is associated with hurdles. High initial investments, complex interfaces between IT, automation and quality management as well as the lack of qualified specialists present companies with major challenges. However, this is precisely why it is advisable to proceed step by step: Pilot projects offer the opportunity to minimize risks and build up expertise before the technology is introduced on a large scale. Those who consciously plan this path can actively shape the learning curve and anchor the change in the long term.

Conclusion: Experts Institut as a partner for your transformation

Continuous Manufacturing is not a trend, but the future of pharmaceutical production. Companies that take this step at an early stage not only secure advantages in terms of efficiency and quality, but also with regard to regulatory acceptance and market position.

The Experts Institute supports you with practical advice, tailored training and support for your digitalization and modernization projects. From the feasibility analysis and the development of an implementation plan through to regulatory-compliant implementation, we accompany you on your path to continuous production.

Contact us for customized solutions, together we will make your production future-proof. Get ahead and in touch with us – info@expertsinstitut.de

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How to create an effective quality management system (QMS) in accordance with ISO 9001

A quality management system (QMS) in accordance with ISO 9001 is much more than a formal set of rules – it is a strategic tool that companies can use to make their internal processes transparent, reliably meet customer expectations and build lasting trust with employees, partners and customers. Those who see quality management not as an obligation, but as a lived practice, lay the foundation for sustainable efficiency, risk minimization and genuine market success.

In an increasingly complex business world with global supply chains, stricter regulatory requirements and growing competitive pressure, the question of reliable quality is coming into focus. Companies that want to be future-proof in particular need structured systems to systematically meet requirements and at the same time actively exploit potential for improvement. The ISO 9001 standard provides the globally recognized framework for this, but it only unfolds its full benefits when it is integrated into everyday working life and actively lived.

QMS

What ISO 9001 requires and why it is relevant for you

A central idea of ISO 9001 is understanding the context of your organization. What internal and external factors influence your company? What are the requirements of customers, regulatory authorities, partners or your own employees? If you take a close look at these questions, you will create the basis for a tailor-made QMS that is not only based on standards, but also on the reality of your company.

The standard also requires opportunities and risks to be systematically analyzed and specific measures to be derived from this. It requires a clear definition of the scope of the quality management system and a regular review of the strategic orientation.

Leadership begins with responsibility for quality

ISO 9001 emphasizes the role of top management in quality management. Quality is not a task that can be delegated, it must be actively exemplified. This means that management should not only formulate a binding quality policy, but also communicate it in order to involve employees and anchor the topic in everyday life.

Customer satisfaction is a strategic goal and quality is the instrument for achieving this goal in the long term. An effective QMS supports the company management in fulfilling this responsibility in a structured manner.

Documentation creates structure and reliability

A central element of ISO 9001 is the control and maintenance of documented information. Whether test reports, work instructions or training certificates: All relevant documents must be traceable, versioned, released and stored securely.

Many companies benefit from a digital document management system that enables transparency, consistency and quick access. The goal is clear: processes should not only take place, they should be documented, controllable and continuously improvable.

Anchoring quality in day-to-day business

A quality management system must not be a mere paper tiger construct. ISO 9001 explicitly requires quality to be visible and effective in day-to-day work. This includes, for example, the process-oriented control of procedures, the selection and qualification of external service providers or a well thought-out approach to dealing with deviations and complaints.

Companies that carry out regular internal audits, actively involve their employees and take feedback seriously create a dynamic quality culture and ensure that their QMS also works on a day-to-day basis.

Measure, evaluate, improve – with a system

Only what is measured can be improved. This is why ISO 9001 provides for regular assessments of quality performance based on clear key figures, systematically recorded customer satisfaction and documented audit results.

Management assessments are not an end in themselves, but an important tool for strategic control. They help to make well-founded decisions and identify potential for improvement at an early stage.

Continuous improvement as an attitude

A strong QMS is not a static structure. It thrives on the willingness to improve. Corrective and preventive measures, lessons learned from projects and audits and the active involvement of employees in improvement processes ensure that quality does not stagnate, but grows.

ISO 9001 makes it clear that quality is not a project with a beginning and an end, but a continuous process that must be lived.

Conclusion: Long-term success with a practiced QMS

A quality management system in accordance with ISO 9001 can make all the difference – between reactive troubleshooting and proactive corporate management. It helps to create clarity in complex processes, identify risks, exploit potential and convince customers and employees in the long term.

At a time when trust, transparency and efficiency are crucial to success, a practiced QMS is becoming a strategic success factor – far beyond certification.

Would you like to further develop your quality management?

Whether GAP analysis, audit preparation or operational implementation – we accompany you on the way to an effective quality management system in accordance with ISO 9001. Get ahead and in touch with us – info@expertsinstitut.de

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Untrue Supplier-Audit Reports: The Danger of Ethnocentric GMP-Auditing

If You are in any QA / QU role and are responsible for audits and audit reports in the GxP-context, I encourage You to take time and read this, it will be worth Your while. And if You are a QP (like I have been), this is likely to help You.

Where We Pick Up the Audit Topic

Manufacturers of pharmaceutical products and marketing authorization holders are required to ensure that audits at critical suppliers and service providers are done in a regular basis: active substance suppliers, suppliers of primary and printed packaging materials, and many others. This is basic, everyone knows this. However…

The supply chain is typically globalized and suppliers and manufacturers of materials are located all over the globe. When audits are carried out at suppliers located in a different culture, auditors always bring in their understanding of GMP and quality expectations-and here is the news: these are projected by the auditors on the auditees in culturally driven way and interpretation.

Auditors are Biased and Lack Understanding

Often auditors are trained to ask clear questions, closed questions, sometimes intentionally open questions, hypothetical questions, and often “show me” questions. Auditors expect to hear clear cut answers, yes or no, black or white, clarity – ambiguity is not typically acceptable as an answer.

But this way of auditing and listening in audits is actually called #ethnocentrism and it leads to very inaccurate audit reports. Such inaccuracy is very dangerous for supply chain and product quality asusrance! And this is a danger this industry cannot affort. We don’t produce umbrellas, but medication, we do this for patients, people who have serious needs…

Auditors assume to be heard and understood like they would be in their own birth cultural context, and even in their own company. It is an expectation which auditors bring with them due to their cultural bias in how communication should work. And so they filter what they see and hear in an audit through what they believe everyone uses to communicate.

Another assumption is that because a standard like GMP is laid down in writing, everyone sort of will understand this the same way, or at least to a contained degree of variability. Another ehtnocentric assumption: keeping in with the text of GMP requirements is what drives quality. As long as everyone else shares this – no problem. But the issue is: not everyone does! As a matter of fact, most cultures in this world do not share the mindset that underlies GMP.

The underlying problem is that GMP and similar quality standards have spawned in a Western cultural framework. This framework is not the majority reality in the world, it is a minority view no matter how important we think we are. Auditors do in almost all cases not know this, and they do not understand how big the impact of this is on what is heard and understood in audits, and what documents and records really mean.

It is needless to say that many drug manufacturing companies care very little about this aspect of audits and audit reports. Since the auditee is perceived as a supplier and only as that, the auditors feel – just like their company – that treating audit situations as an exchange of two business partners is not necessary. Another proof of ethnocentrism.

Real Consequences – Supply Contraction and Patient Risk

Especially in Asia (supplier in China, India, Japan to name a few) this will ultimately lead to a contraction of the supply range, meaning that the supply to European and Western-based companies will be a decreasing market priority to these Asian suppliers. Suppliers in Asia are fine with the Asian market alone, we must not forget that. The West is a very small part of the global village community. If we don’t take this seriously then it is our own fault.

The much bigger issue for the now is though that audit reports most often misrepresent what is going on at the supplier. Miscommunication happens so often without the auditor(s) even noticing it. And it ends up in the audit report, either as a conclusion that a particular audit topic was fine at the supplier (though it wasn’t) or that observations and deficiencies are noted that are simply not true.

The issues that come with ethnocentric auditing, which happens in almost every cross-cultural audit are significant and relevant! And they are essentially unaddressed. Auditors should not be sent into such an audit setting without a proper understandig of this.

Now What?

We seek to train our consultants and audit specialists at EI and our client auditors regarding this issue. And although no person can be truly multicultural, knowing the pitfalls makes a world of difference for the quality that is delivered.

If You are an auditor You cannot guess things in another culture, even in a business or highly regulated setting. Someone needs to show You, teach You, make You understand, and apply it. If not then audit reports will be sub-standard, inaccurate at best. And we will convince ourselves erroneously that we did a good job, and we will deceive ourselves to think that we were the ones who taught the auditee something new, although it is us who had a chance to learn and we did not take it.

Do You want to be an auditor who after 30 or 40 years of work realizes “goodness I got this wrong all my life”? Patient health and safety depend more on accurate auditing than we might think. We owe it to those who depend on medication to do our vey best.

#auditsandinspections #thegoodauditor #interculturalcommunication #GMP #business #activesubstances #api #excipients #supplierqualification #supplychainmanagement

If You like to know more about this, feel free to contact d.gross@expertsinstitut.de or visit www.expertsinstitut.de.

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Insights into our project experience: Successful implementation of quality assurance agreements (QAA) in the pharmaceutical industry

As part of a project for a pharmaceutical manufacturer and its contract manufacturer, we demonstrated our expertise in the implementation of quality assurance agreements (QAA). The aim of the project was to optimize the quality assurance processes and ensure compliance with the current GMP guidelines.
The project was implemented under challenging conditions, which were characterized by strict regulatory requirements and tight schedules. Our team of experienced GMP consultants and QA specialists developed tailor-made solutions, including the creation, review, updating and negotiation of quality assurance agreements, delimitation of responsibility agreements (VAV), technical agreements and QP agreements – in both German and English.
Close coordination with the client’s internal departments and external contractual partners was a key success factor. Thanks to targeted project management and precise negotiating skills, time-critical contracts were concluded on schedule. We also optimized relevant processes, revised SOPs and templates, thereby achieving significant efficiency gains.
Our expertise in supplier management and supplier qualification was crucial to the success of the project. In addition, we ensured sustainable implementation and compliance with regulatory requirements through targeted induction and training of the teams.
The successful implementation of the project not only led to a noticeable improvement in quality assurance, but also to a deepening of cooperation with the customers. This example illustrates how even complex challenges can be overcome with a clear strategy, sound expertise and a well-coordinated team.

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GMP standards for medicinal cannabis: guaranteeing quality in an emerging industry

The medical use of cannabis is gaining increasing recognition and legal approval worldwide, leading to growing demand and increased regulation. In this dynamic environment, Good Manufacturing Practice (GMP) standards are crucial for the production of safe, high-quality products. However, the implementation of GMP standards is a challenge for the medical cannabis industry, as many companies first need to establish the necessary structures and skills. Specialized consulting can make a significant contribution to the efficient implementation of GMP-compliant processes.

GMP standards and their importance in medical cannabis production

GMP standards, implemented by the Food and Drug Administration (FDA) and further developed by the World Health Organization (WHO) and adapted to the global market, are a global quality benchmark for the pharmaceutical industry. These standards require strict specifications for the documentation, control and monitoring of production processes in order to ensure product safety and efficacy [1]. In the medical cannabis industry, these standards are of fundamental importance, as there are no guidelines specifically developed for cannabis production, although cannabis products are also used as medicines and can affect vulnerable patient groups. Instead, reference is made to the general processing of herbal substances [2], which is particularly important in the drying and preparation of plants. GMP ensures that all products are manufactured in a hygienic environment under controlled conditions to avoid contamination and ensure the safety of the final products [3].

Challenges of GMP implementation in the cannabis industry

GMP implementation in cannabis production poses specific challenges. For example, ensuring consistent product quality requires precise control over the entire manufacturing process – from raw material extraction to bottling. Medical cannabis products must have consistent concentrations of active ingredients to ensure therapeutic effects, which requires precise process control and laboratory testing [4]. In many cases, however, companies lack comprehensive knowledge of GMP standards and their specific application to cannabis production.

GMP compliance is complex and requires not only the establishment of suitable processes, but also the training of personnel and the implementation of quality assurance systems. In addition, regulatory requirements vary from country to country and are constantly evolving. Strategic advice can help to overcome specific challenges and ensure ongoing compliance with GMP requirements.

Good manufacturing practice (GMP) in practice: important steps and measures

1. production environment and hygiene: GMP guidelines require a strictly controlled production environment to prevent contamination by microorganisms, heavy metals or pesticides. Cannabis products must not contain any undesirable residues that could impair efficacy or safety [5].

2. quality control and laboratory testing: Each production batch of medicinal cannabis must undergo rigorous testing to confirm the active ingredient content and rule out impurities. These laboratory tests ensure that the final product meets quality standards and that consumers are not exposed to any risks [3].

3. documentation and traceability: GMP compliance requires comprehensive documentation and complete traceability of products in order to be able to act quickly in the event of quality problems or recalls. Every production stage, every test and every release must be documented in detail in order to prove conformity [1].

4. staff training: GMP standards require continuous training and education of employees to ensure that all processes are carried out and documented correctly. For many companies in the cannabis industry, this poses an additional challenge, as specific GMP knowledge is often not sufficiently available in the team [4].

The added value of specialized consulting for GMP-compliant processes

Strict compliance with GMP standards is essential for companies in the medical cannabis industry in order to be successful on international markets and build trust with consumers. However, especially for companies that are new to the market, the implementation of these standards requires considerable organizational and financial effort.

Our consulting expertise supports you in all phases of GMP implementation – from the development of a customized quality management system to employee training and complete documentation. We also offer regular audits and support in preparing for inspections to ensure continuous GMP compliance.

Conclusion: GMP as a guarantee of safety and trust in the medical cannabis industry

The requirements for medical cannabis are constantly increasing, as patient safety is a top priority and regulatory requirements are growing. The implementation and maintenance of GMP standards are a basic requirement for any company that wants to establish itself in this market in the long term.

We are happy to support you in achieving GMP compliance cost-efficiently and sustainably, strengthening your market position and guaranteeing the safety of your products. Get ahead and in touch with us – info@expertsinstitut.de

Sources

1. Good Manufacturing Practices for Pharmaceutical Products: Main Principles. World Health Organization (WHO).

2. cannabis Q&A for the public

3. Quality Standards and Practices in the Medical Cannabis Industry. International Journal of Drug Policy.

4. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. WHO, 2003.

5. Good Distribution Practice for Medical Cannabis Products. European Commission, 2017.

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GxP audits: How important are they and how are they conducted?

In the highly regulated pharmaceutical industry, audits are more than just a control mechanism – they are an indispensable tool for ensuring the quality and compliance of processes. Audits play a key role in ensuring that companies adhere to the strict requirements of Good Manufacturing Practice (GMP) and other GxP standards. The aim is not only to identify errors, but also to continuously improve processes and eliminate weaknesses before they lead to errors or quality problems. The role of audits in quality management can therefore not be overestimated. They help to meet regulatory requirements and at the same time strengthen the trust of customers and authorities in the company.

Below you will find out what a GxP audit is, why it is so important for companies in regulated industries and how it can be carried out optimally.

What is a GxP audit?

An audit is a systematic, independent and documented review that serves to determine whether activities and results meet the planned requirements. So much for the theory.

In the GxP area, audits are particularly important in practice, as they ensure that all processes actually meet the strict requirements of GMP, GLP and GCP standards. These audits not only check compliance with regulations, but also whether processes are used for continuous improvement and risk reduction and actually make this contribution.

Why are audits in the GxP area so important?

Audits fulfill a central function in the so-called Pharmaceutical Quality System (PQS) and offer many advantages that are important for the entire industry:

  • Audits guarantee that companies comply with and implement the legal and regulatory requirements in such a way that the medicines produced are of truly impeccable quality and also safe.
  • Audits make it possible to identify potential errors in operations and production at an early stage so that measures can be taken to minimize risks. This prevents critical errors or weaknesses in the production process from leading to serious problems and questionable medicines from reaching the market and patients.
  • Audits offer the opportunity to evaluate existing processes and identify optimization potential. In this way, companies can increase their efficiency and improve quality at the same time.
  • Regular audits strengthen the trust of customers, partners and regulatory authorities. A well-documented and executed audit shows that the company is able to critically scrutinize itself in order to reliably deliver high-quality products to the market.

The audit process: step by step

An audit in the GxP area follows a structured procedure that enables the auditor to thoroughly examine the processes in the company. Typically, an audit consists of six main phases:

  1. Planning: Audit preparation is crucial for success. The parties involved must ensure that all relevant people and documents are available. Thorough planning ensures a smooth process.
  2. The initial meeting: In this step, the auditors and the representatives of the company to be audited meet at the start of the audit. The audit plan or the audit agenda is discussed again. Questions are also clarified here and expectations are defined if they have not already been clearly understood before the audit.
  3. Conducting the audit: The auditor checks the company’s premises, machines, documents and processes. Interviews with employees also take place during this phase in order to assess the practical implementation of the processes.
  4. The final meeting: At the end of the audit, the results are summarized. This is where we discuss what worked well and where there is room for improvement.
  5. The audit report: The auditor prepares a detailed report documenting the results of the audit. This report also contains recommendations to help the company eliminate weaknesses and further improve processes.
  6. Follow-up of the audit results: After the audit, follow-up is essential to ensure that the recommended measures have been implemented. This includes documenting the corrections and, if necessary, rechecks to ensure the sustainability of the improvements.

Preparing the audited company for a GxP audit: how to succeed

Thorough preparation is the key to a successful audit. Companies should ensure that their documents are complete and up-to-date and that their employees are aware of the requirements of the audit. Employee training plays a central role here, as a well-prepared team helps to ensure that the audit runs smoothly and possible deficiencies can be identified at an early stage.

Tips for audit preparation:

  • Review all important documents, including SOPs (standard operating procedures), batch documentation and qualification documents
  • If possible, carry out internal mock audits in advance to identify weaknesses in advance
  • Bring your team up to speed on regulatory requirements and audit expectations

Successful audit practice: the key to success

A successful audit requires careful preparation, a clear structure and detailed follow-up. Cooperation between the auditor and the audited company is of great importance in order to develop a common understanding of the requirements and expectations. This not only promotes compliance, but also the continuous improvement of processes. Companies that integrate regular audits into their business processes improve their quality assurance and reduce the risk of production errors or non-compliance with regulations.

Conclusion: Audits as the key to quality assurance

Audits are an indispensable part of quality management in the GxP sector. They not only help to ensure compliance with regulations, but also promote the quality and safety of products. Thorough preparation and the selection of experienced auditors are crucial to the success of an audit.

At Experts Institut, we not only offer training courses for auditors, but are also happy to support you in ensuring your compliance and continuously improving your processes. We can do “audits”. Contact us at info@expertsinstitut.de

Would you like to find out more?

Listen to our podcast episode “Audits in the pharmaceutical industry”, in which we examine the importance and challenges of audits in detail: https://podcasters.spotify.com/pod/show/experts-insights/episodes/Audits-in-der-Pharmaindustrie-e2of577

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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 the concept paper tells us-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

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 towards 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 to 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 optimizing 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 into 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. So – get ahead with it!

Experts Institute 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).

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