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.
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
https://experts-institut.com/wp-content/uploads/2025/09/LinkedIn.png10801920Christoph Köthhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpChristoph Köth2025-09-24 18:35:572025-09-25 08:59:11Continuous manufacturing: future trend in the pharmaceutical industry
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.
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
https://experts-institut.com/wp-content/uploads/2025/07/LinkedIn-Kopie.jpg10801920Lirim Smajlihttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpLirim Smajli2025-07-31 10:39:432025-07-31 10:39:53How to create an effective quality management system (QMS) in accordance with ISO 9001
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.
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.
https://experts-institut.com/wp-content/uploads/2024/12/Screenshot-2024-12-04-090331.png432769Marina Weegerhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpMarina Weeger2024-12-04 08:59:252024-12-04 09:45:40Insights into our project experience: Successful implementation of quality assurance agreements (QAA) in the pharmaceutical industry
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:
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.
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.
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.
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.
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.
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
https://experts-institut.com/wp-content/uploads/2024/10/LinkedIn-3.png10801920Dr. rer. nat. Dietmar Grosshttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpDr. rer. nat. Dietmar Gross2024-10-28 12:20:122024-10-29 09:55:18GxP audits: How important are they and how are they conducted?
English is common for most who work in a GxP-regulated industry. Though most would consider themselves firm English speakers, the truth of the matter is: most will never go beyond some standard vocabulary, and most have only little understanding of English grammar and writing style. After the Brexit, in Europe very few are English native speakers. One could likely make a case for that even English EU GxP Guidance and Drug Regulation documents suffer from this issue.
No, English is in fact not easy – good English is just not!
In company GxP documents and reports the English text often suffers from features of other languages which are unknowingly imposed on it because authors and reviewers are not native speakers.
Consequences of Poor Language Quality
Clarity and quality suffer, content is misrepresented, reports are harder to read later on, procedures are misinterpreted due to undetected ambiguity, even wrong conclusions can be the consequence of using substandard “EUnglish” instead of actual English.
And when a native English speaking authority comes in for inspection (USFDA, TGA, MHRA) all of a sudden QA wonders why the authorities have such trouble seeing through the local QMS and GxP-system and find what they read rather irksome (if You need to look up “irksome” then I totally got You!).
“And here we thought all is fine…”.
Tailored Training by Experts Institute
Experts Institut offers a customized and Taylor-made applicational training on “Technical Editing of GxP Documents: The Relevance of Quality and Style”. This training is relevant for really all levels of GMP-/GxP-regulated organizations. The training provides theoretical elements of English language features and how they can interfere with other languages in GxP documents and reports. Important elements in English writing style are presented as well. Application of the theoretical part is then trained in inductive workshop sections to gain immediate hands-on understanding of how all this plays out in real GxP life.
Basic quality systems can make good use of this, just as well established ones can.
It is a great contribution to the foundation of Pharmaceutical Quality Management Maturity.
This training is one of many reasons why Experts Institut is so unique in its work portfolio: We go beyond GMP/GxP-only – We see the big picture – We see the whole.
For your benefit.
Feel free to contact us and make an appointment to talk about how we can customize this expertise to Your need. Get ahead and in touch with us – info@expertsinstitut.de
Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge, reflecting different cultures from around the world. This is one reason why many would assume that the entire world can be talked to, related to, and understood quite readily. It is part of everyday work for many after all-or so we think.
In the area of audits and inspections, crossing cultures happens all the time. Different cultures bring different perspectives, which can influence how audits are perceived and conducted. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings. Understanding the nuances of each culture involved is essential for effective communication and successful outcomes.
True Multiculturalism and Cultural Limits
This poses a problem though: we learn to communicate, read, and perceive in our birth culture.
And even if a society is highly diverse, we are still product of a cultural framework that is discrete-in other words, that has boundaries.
It is simply impossible for one person to really become multicultural-ourlifespan is just not large enough.
You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.
So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all).
We may think we know what is going on around us when we engage people from other host cultures, but we really do not.
Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person.
We believe we know and understand.
But we miss most of it in reality.
We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture.
And we cannot stop doing it because we are not even aware of it.
The Impact of Culture on Audits and Inspections
And now it gets interesting: This problem includes audit and inspection situations! Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.
Culture is so powerful that it controls everything we think, say and do.
And what we expect of others.
In an audit situation (also in GMP inspections), this routinely produces misunderstandings.
And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.
From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.
An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all.
But the auditor is blind to this.
As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies-even the judgment on severeness.
If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve.
The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate.
We do a disservice to the auditee and to our own sending unit.
And frankly, to ourselves…
This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.
How can you improve?
Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.
Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.
Respect that standards-even GMP-can be lived effectively in different ways.
Open to the truth that you do not know everything best.
CS are becoming increasingly important, especially in the pharmaceutical industry, in order to meet the increasing demands on production. At the same time, their use must not compromise patient safety.
This brings with it increasing challenges in the scope of validation and qualification of the system: Proof that CS function properly and do not pose an increased risk to patients can only be provided by taking a holistic view of the system. A master plan is therefore a useful document for defining the scope of the project.
Complexity of the scope of validation
The initial classification of the CS into a software category according to GAMP 5 provides guidance on the complexity of the scope of validation:
Operating systems
N/A
Non-configurable software (standard software)
Configurable software
Individual customer software
A risk assessment is now used to check the criticality of the CS with regard to GxP relevance, i.e. the extent to which there is an impact on patient safety. A detailed identification and analysis of risks and the definition of suitable control measures to minimize or completely exclude these risks is essential. A continuous review is also essential for a complete audit.
In addition to determining areas of application, exact specifications and their influence on patient safety, individually planned tests with suitable acceptance criteria are also included in the CS review.
The validation of the process then goes hand in hand with the qualification of the process environment, divided into the phases of design, installation, function and performance testing. This allows individual specifications to be checked and verified step by step.
Only once qualification and validation have been successfully completed and proof of suitability for the intended process has been provided can the CS be used without any increased risk to patient safety.
Field report by an EI consultant from a supplier qualification project for pharmaceutical manufacturers
In the period from 2019 to 2022, I was involved in a project for the supplier qualification of drug manufacturers and active ingredient manufacturers at a pharmaceutical company and generics manufacturer. The project team, consisting of up to four colleagues, was entrusted with various tasks and focal points to ensure smooth implementation.
Project overview and responsibilities
Before I took over the management of this project, my colleagues had already developed a checklist for the review of audit and inspection reports. As project coordinator, my main responsibility was to manage, coordinate and plan the activities. My tasks included direct customer contact and the exchange of information as well as requesting and evaluating audit reports for supplier qualification. I was also responsible for the creation and versioning of technical agreements, supplier monitoring and internal coordination with the specialist departments.
Inspection reports and quality assurance in supplier qualification
One of my main tasks was to check and evaluate the inspection reports (audit reports) for content, accuracy and completeness in accordance with the applicable GMP guidelines for the products and to document this using internal guidelines (SOPs) and checklists (audit report review).
Challenges
The challenges in this project were manifold. A tight schedule due to upcoming production & product releases required the tasks to be completed on time. In addition, global customer contact required effective communication and coordination across European borders. Another challenge was to work through the previous year’s backlog while maintaining ongoing business, particularly due to staff shortages and changes in the team. After completion of the project at the customer’s site, it was important to transfer the newly acquired knowledge and processes to the resident and newly hired staff and to ensure that the quality assurance processes & measures are continuously implemented and adhered to.
Successes and results of supplier qualification
Despite the challenges, the long-term collaboration within the team was very successful and our structured approach enabled us to fully meet the client’s requirements. Our work contributed significantly to the quality assurance of the company’s medicines and ensured that suppliers met the required quality standards.
Contact and support for supplier qualification
Are you also looking for support in supplier qualification or quality management? Our experienced team is ready to make your project a success. Contact us for a customized solution that is precisely tailored to your needs. Get ahead and in touch with us – info@expertsinstitut.de
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 towards 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 everything 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 operational 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),
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 even have that.
The second layer is often 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 are 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 importantly – 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
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