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.
Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge. 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. 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.
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—our lifespan 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.
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.
Want to know more? Ask for cross-cultural factor training for auditors and inspectors @ExpertsInstitut.
We can help You. And after this You will never be the same. You will be a better auditor. You may—in fact—be a better You. Yes – really.
Retaxations in pharmacies mean that the health insurance companies reclaim money that they have previously paid to pharmacies for the dispensing of medicines. This usually happens up to 15 months after the drug has been dispensed. This is particularly lucrative for health insurance companies, for example in the case of pharmacies that manufacture cytostatics. Cytostatic drugs are chemotherapy drugs that are used to treat cancer. Pharmacies produce these medicines in special laboratories according to the doctor’s instructions and in compliance with strict regulations. This production is always adapted to the individual patient.
With regard to the retaxation of cytostatic drugs, this means that health insurance funds check whether the dispensing and billing of these drugs by pharmacies has been carried out properly and whether all regulations have been complied with. If this is not the case, the health insurance company can demand money back and often uses this simply as a prophylactic measure to reduce the funds. In most cases, this is due to formal errors in the prescription (e.g. pink prescription issued by the doctor) or the billing of wastage (remaining quantities of the medicine required for production).
Retaxations can be very costly and economically ruinous for pharmacies and are often the subject of controversy and discussion between pharmacies and health insurance companies. However, pharmacies often lack the staff, time and expertise to process the mountain of retaxations and to draw up appeals with all the supporting documents in good time.
Strategies for avoiding retaxations
Careful documentation: Precise and complete documentation of all processes, from prescribing to dispensing the medication, can help to avoid errors and maintain an overview.
Ongoing training: Regular training of pharmacy staff on current regulations and billing practices can help eliminate common sources of error.
Proactive communication: A close exchange with doctors and health insurance companies can prevent misunderstandings and clarify problems at an early stage.
This is where we, the Experts Institut, come in with our special retaxation service. Since 2008, we have been supporting pharmacies in taking professional and effective action against unjustified retaxations by health insurance companies. With our expertise and experience, we offer tailor-made solutions that relieve pharmacies of staff and help to minimize economic losses.
https://experts-institut.com/wp-content/uploads/2024/07/9.jpg10801920Fabienne Griegerhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpFabienne Grieger2024-07-16 09:12:132024-07-16 09:13:00Retaxation – a lucrative instrument for health insurance companies
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.
How artificial intelligence is revolutionizing management consulting: Insights into a future where consultants and AI, go hand in hand
AI until 2030
In the rapidly evolving business world, companies face the challenge of keeping up with the latest technologies in order to remain competitive. Artificial intelligence (AI) is playing an increasingly important role in this transformation. In this context, the question of whether AI can replace the traditional management consultant is becoming increasingly important. Research, such as McKinsey & Company’s study, “Generative AI and the Future of Work in America,” predicts that by 2030, generative AI will automate tasks that currently account for up to 30% of labor hours in the U.S. economy. However, this automation will expand the way we work in specialized areas, not replace it.
Deloitte’s report “State of Generative AI in the Enterprise”
The question is whether the growing interest in artificial intelligence will win the race or whether fears and regulatory hurdles, particularly in the area of compliance, will gain the upper hand. Do the potentials of the technology outweigh the reservations, or are the latter blocking broad acceptance? Deloitte’s report “State of Generative AI in the Enterprise” shows a clear trend. Executives are enthusiastic about the possibilities of generative AI, with 62% rating generative AI as exciting. Nevertheless, there is a certain degree of uncertainty (30%). A majority (79%) expect generative AI to bring about significant transformations in their organizations and industries in the next three years.
Data protection and compliance
While concerns regarding data protection and compliance, for example, are certainly justified in the discussion about artificial intelligence, this debate leads to a significant insight: the role of the management consultant is not diminished by the integration of AI, but rather significantly expanded. By incorporating AI into their services, consultants can provide more data-driven, accurate and efficient solutions. This symbiosis of human expertise and AI capabilities promotes deeper analysis and a refined understanding of complex challenges, which ultimately increases the quality of advice and offers added value for the customer.
Commerzbank provides an innovative example of the application of AI in customer advice with the introduction of an AI-based banking avatar that combines generative AI and avatar technology to improve the customer experience. This underlines the versatility of AI in supporting and improving customer interactions and experiences.
Integration of AI
The integration of AI into management consulting (management consulting at EI) therefore not only enables more efficient data analysis and processing, but also promotes innovation and strategic development. Management consultants who use AI can concentrate on complex analysis and strategy tasks and thus create greater added value for their clients. This development indicates that the AI-savvy consultant will replace the traditional consultant without the use of AI in the digitally transformed business world. Integrating AI into consulting services is not just a possibility, but a necessity to be successful in the modern business world.
Bibliography:
Deloitte. (2024). State of Generative AI in the Enterprise. [Bericht].
McKinsey Global Institute. (2023). Generative AI and the Future of Work in America. [Studie].
Commerzbank Aktiengesellschaft. (2023). Commerzbank plans banking avatar based on artificial intelligence. [Pressemitteilung]. Frankfurt am Main: Commerzbank Aktiengesellschaft.
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
Artificial intelligence (AI) is more than just a buzzword from the world of science fiction and robotics – it is a technology that is deeply integrated into our everyday lives. As a dynamic and progressive field, AI aims to develop systems that are capable of performing tasks previously reserved for the human mind. Whether it’s algorithms that learn from experience or systems that can understand and respond to human language, AI is opening up new horizons in technological development. It promises to fundamentally change the way we work and live by optimizing processes, creating innovative solutions and improving efficiency. In addition, AI enables more natural interaction between humans and machines through the development of intuitive user interfaces and voice assistants that make our everyday lives easier. With its ability to transform industries from medicine to manufacturing, AI has gone from a concept of the distant future to a present reality that is revolutionizing the business world across all sectors.
Technologischer Fortschritt
Experts Institut Beratungs GmbH recognized the transformative power of artificial intelligence at an early stage. Our commitment to the use of AI technology is aimed at optimizing our operations, overcoming real challenges and creating substantial added value. Our decision to integrate AI into the way we work is based on the conviction that technological progress should improve our lives and create more efficient and intelligent solutions.
KI-Technologie
The transition to AI technology not only marks a technological advance for us, but is also an expression of our commitment to customers and employees to create a better, more functional future. This strategic orientation is based on careful planning and a commitment to ethical principles and sustainability in dealing with AI.
At Experts Institute, we are more than a team – we are a community dedicated to making a positive impact on the future. Together, we want to explore the many possibilities that artificial intelligence opens up for us and thus pave the way to a promising future.
https://experts-institut.com/wp-content/uploads/2023/11/DALL·E-2023-11-05-14.56.45-Refine-the-double-exposure-image-of-the-silhouette-of-a-Hispanic-man-with-themes-related-to-the-pharmaceutical-industry.-The-man-is-in-contemporary-bu.png10241792Dipl. Ing. Wolfgang Rudloffhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpDipl. Ing. Wolfgang Rudloff2024-03-23 12:20:132024-03-23 12:25:54Shaping the future: AI as the key to progressive corporate governance
a document that is awaited with more excitement than ever before in the history of GMP regulations. One reason for this is that Annex 1 has now been available as a draft for more than 4 years and its publication has been repeatedly delayed for various reasons. According to current information, the publication is now scheduled for September 2022.
What is new and therefore very special?
On the one hand, the (recommended) scope of Annex 1 has been significantly expanded. In future, the focus will no longer be solely on the manufacture of sterile medicinal products, but it is recommended that “principlescan also be used to support the manufacture of other products that are not intended to be sterile, such as certain liquids, creams, ointments and biological intermediates with low biological load”. It can therefore be assumed that the requirements, e.g. for the definitions of cleanroom zoning and the associated qualification and implementation of monitoring, will then also be applied to other production facilities that were not previously included in the Annex 1 control loop.
Monitoring of processes
The topic of monitoring processes, including the requirements for the expertise of all those involved in the value creation process, is then very much in focus and clear expectations are defined. For example, the specification of the bacterial load in the A zone changes from previously < 1 CFU/m³ air volume in the monitoring of room conditions to 0 CFU/m³ (“no growth”) with the expectation that every occurrence of a germ is immediately transferred to an investigation (deviation), with the requirement that the “real cause” is also determined. Annex 1 then formulates the requirement that the process control in the manufacture of sterile medicinal products is closely monitored, e.g. with the requirement of QA monitoring through windows in the cleanroom that allow a complete view of the processes, or alternatively by means of recording cameras.
The central theme in Annex 1
however, is the requirement to implement a so-called contamination control strategy (CCS) in the company, which, on the basis of a detailed risk analysis, determines the corresponding assessments of possible influencing factors for the occurrence of particulate or microbial contamination and defines the strategic measures for defense / monitoring. In the current reading of the new Annex1 , this is to be interpreted as meaning that, in addition to the SMF and VMP, a further strategy document should be created and maintained at a high level in the company’s organizational structure on the basis of a well-implemented risk management system.
Overall, Annex 1 has become much more technical. This is the first time that the media systems have been recorded in great detail and clear requirements for the design / definition of acceptance criteria have been formulated and specified.
APS (Aseptic Process Simulation)
A large part of the new Annex 1 is taken up by the actual production, including the chapter of the APS (Aseptic Process Simulation) formerly known as MediaFill. There are not necessarily any revolutionary changes, but there is a significantly greater specification of current practice combined with the requirements for the qualification of those involved and the targeted use of the risk management system.
Conclusion
Very exciting, very ambitious. With publication, it will be a major task in the company to evaluate the many clarifications / new requirements and changes, and to derive and implement the right conclusions with regard to implementation.
More information
Please contact us for further training and consulting services relating to Annex 1 via e-mailinfo@expertsinstitut.de
Target group
The online seminar is no longer only aimed at employees working with sterile medicinal products, but is open to the entire spectrum, i.e. everyone involved in the implementation / execution of Annex 1 in the company. Departments such as production, quality, QA / QC, as well as engineering, plant manufacturers and also inspectors benefit from the knowledge imparted in this seminar. Contact: info@expertsinstitut.de
https://experts-institut.com/wp-content/uploads/2023/10/Ludwig_A_photo_of_a_CEO_and_his_advisor_and_a_business_man_disc_a3dfa66c-c215-4a19-93d7-516a4de4c1e8.png8161456Dipl. Ing. Wolfgang Rudloffhttps://experts-institut.de/wp-content/uploads/2023/02/GEMI_Logo_Slogan_color_RGB.webpDipl. Ing. Wolfgang Rudloff2023-02-18 17:18:092024-10-29 07:59:27Annex 1 – Revolution in GMP heaven?
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