September 25 @ 2:09 pm

De volgende open training sessie is onze 2-daagse online training rond Medical Devices & ISO 13485. Deze gaat door op 29 juni en 4 september 2020. Deze training geeft u een brede achtergrond over GMP’s & vereisten omtrent Medische Hulpmiddelen. De vraag naar veiligheid neemt voortdurend toe in de MED-tech-industrie. In mei 2020 zal de nieuwe verordening over medische hulpmiddelen, die eerder door de Europese Raad en het Parlement werd goedgekeurd, in werking treden.  Deze training geeft een praktische invulling hiervan.  In groep worden de nieuwe verwachtingen besproken en bekeken wat dit in de praktijk betekent.

Het verschil tussen een webinar en online training is dat er meer de focus gelegd wordt op leren door de tijd online optimaal te gebruiken voor interactie en discussie. Hier gebruiken we aangepaste methodes voor. Via een onze blended learning approach wordt de tijd online afgewisseld met pre-readings en oefeningen.

Wederom in samenwerking met Co-Valent. Onze opleidingen binnen onze Q-Academy zijn “gratis” beschikbaar via Co-valent: Co-valent biedt GRATIS opleidingen aan voor ondernemingen die behoren tot de life science sector – paritair comité 116 (arbeiders) of 207 (bedienden).

Hierbij een overzicht en de nodige links om u in te schrijven:

  • Via covalent klik hier   (Taal = NL – Categorie = Farmacie & Biotechnologie)
  • Via onze website klik hier

At Q-People we like to stay ahead… In more restricted times, new ways of collaboration are advised. That is why a topic like collective intelligence is put on our training program. Collective Intelligence is the power of a group of people to resolve problems. We meet 15% of our working time, and often with no results. Proposals and projects are blocked, and it gives the impressions that we lost precious time. A more practical and efficient way of meeting, with collective thinking will give tools to facilitate and let the things move forward.

The legendary bassist Carol Kaye, also proved it is not only a man’s world…. She is an American musician, who is one of the most prolific recorded bass guitarists in rock and pop music, playing on an estimated 10,000 recordings in a career spanning over 50 years. Enjoy the beauty of gender equality… https://youtu.be/QEH-wfo7nPo

Er zijn extra plaatsen voorzien voor onze uitgebreide 2-daagse Validatie Training “Basics in Validatie”, waarbij je zal meegenomen worden in de wereld van C&Q (Commissioning & Qualification). Deze 2 dagen gaan we van de basis naar tips en tricks om op een hoger niveau te komen binnen de validatie. Al de sessies van onze Q-Academy worden via Co-Valent verzorgt in Geel: www.officenter.eu.

DAG 1: Voor professionals die nieuw zijn in de (bio-)farmaceutische of biomedische industrie, legt deze training uit waarom regulatorische autoriteiten validatie verwachten. Bovendien worden de mogelijke gevolgen van niet – of foutief gevalideerde processen of systemen besproken.

Voor meer details DAG 1: https://www.co-valent.be/nl/details-formations/

Dag 2: Voor meer ervaren professionals gaan we dieper in op de details, pitfalls en mogelijke tips en tricks om de validatie projecten effectiever uit te rollen, te begeleiden of zelfs te leiden.

Voor meer details DAG2 : https://www.co-valent.be/nl/details-formations/

A great succes it was for our 3-day Contamination Controle Training at Darwin wetenschapspark, Niel. This in close collaboration with Co-valent (vormingsfonds PC 116 & 207).

This course provides basic scientific and technical background to understand drug company’s main goal: Manufacture products which are Safe, Pure and Effective [GMP Compliant].  We will discuss different prevention and control systems applied. We will also discuss the regulations and current expectations which address this topic.

Contamination control has long been one of the main challenges in pharmaceutical production as nothing is a greater liability to the safety of patient. This course gives participants helicopter view to understand the main tools and systems used for (cross-) contamination prevention & control in drug manufacturing sites. With this overview the person can start in any job in pharma with more understanding.

A successful training session “Technical Writing: Deviation Handling” at Darwin wetenschapspark, Niel. This in close collaboration with Co-valent (vormingsfonds PC 116 & 207). This training gives trainees a broad background in GMP Writing Skills.

The aim of this course is to enhance the employees GMP writing skills in different areas to write clear, readable and defendable documents. The style and skills required for formal business writing are best developed by practice and experience, but with the right tools and know-how it is a first start.

The aim of the training is to develop the ability to perform the tasks individually and right first time.

Last year, Elizabeth Holmes, founder of Silicon Valley startup Theranos, was charged with nine counts of wire fraud and two counts of conspiracy to commit wire fraud, and she faces 20 years in jail if convicted. Why? For claiming that her company could run medical tests using a single drop of blood.

The public was misled by Holmes and former Theranos president Ramesh Balwani through a massive lack of transparency. The company did not have peer-reviewed evidence proving the safety and effectiveness of its blood-testing machine, and questions went unanswered about the integrity of Holmes and Theranos, leading to the company’s eventual demise. Although many lessons can be learned from Theranos’ failure, the one that stands out the most is this: Transparency is essential throughout the entire product development life cycle.

Transparency is critical for all industries these days, but especially for the life sciences sector. When it comes to innovative services and products from emerging life sciences companies, transparency can be pivotal to preventing fraud and wasted investments. It can help keep investors informed and up-to-date, improve product development processes and quite literally save people’s lives.

Below are five ways to achieve and maintain continual transparency in a fast-growing life sciences company:

1. Keep investors informed. Since your investors are financially backing your company and its products, they have every right to full transparency of products being created. They should be communicated with regularly and made aware of the development steps taken, any changes made to processes, and notable failures and successes throughout the entire product development life cycle.

That said, venture capital interest can be difficult to snag these days, especially for life sciences startups. Consider other funding sources available, such as angel investors, private placement, incubators, entrepreneurial competitions, crowdfunding as well as city, state and county resources. Above all, remember that no investment pitch—no matter the investor source receiving it—will succeed without a specific clinical date, clear unmet and demonstrable cost savings over existing solutions/treatments, and a commitment to peer-reviewed research and transparency.

2. Digitize all assets and processes. As technology advances and market demands intensify, systems that rely on inefficient, insecure, and costly paper-based and hybrid processes are falling short. By digitizing all assets and processes, life sciences companies can remain competitive and avoid a Theranos-esque debacle by making information more readily available to company stakeholders. Additionally, digital systems can help strengthen data integrity, which provides the assurance of accuracy. When first initiating a digitization project, it’s important to begin by analyzing all existing systems, processes, tasks, and assets, including those already leveraging digitization.

Also during digitization projects, keep in mind that any data being generated throughout R&D and manufacturing, supply chain and patient aftercare processes will need to be collected, stored, sifted, and mined for meaning. For many life sciences companies, this calls for strengthening master data management architectures and strategies (especially since IoT data can unleash even more process data). For instance, when a life sciences organization adds data analytics capabilities to its products or processes, usability can be radically improved without a dramatic increase to the price point. Furthermore, when combined with IP connectivity, such data is easy to collaborate on and transfer, regardless of a users’ location, whether it’s a doctor accessing the information through an app or a pharmacist receiving automatic shelf-stocking notifications.

3. Pass audits and inspections with flying colors. Audits and inspections tend to make employees stressed and unsure of exactly what could happen. “What if I don’t know the answer?” “What if I can’t provide what they are asking for?” Instead of allowing employee stress in an unproductive manner, remember that an auditor’s goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data, while an inspector has a similar goal with respect to the assessment of trial conduct. Transparency can help ensure that trials are run at the level of quality regulators and inspectors expect, and also empower employees to provide auditors and inspectors with the information they require, in the format they’re expecting, and precisely when they ask for it.

4. Encourage collaboration across the entire organization. Ultimately, everyone in a life sciences company needs to be on the same page and be able to effectively collaborate. The right digital solutions can connect employees and any company stakeholders, providing virtual collaboration environments while also avoiding the dangers of information silos. When data is siloed and various business units within a company are unable to share information with one another, errors ensue, work processes slow down, and employee frustration is inevitable. Make sure everyone in the company—from sales and marketing teams, to quality assurance and compliance units, to C-suite executives—is aware of who has access to what data, and ensure that all business units can share, connect, and collaborate to promote a truly transparent culture.

5. Get your clinical trials under control. With an ever-growing collection of data, activities and relationships that can change from day to day, it’s crucial to maintain indivisible connections between clinical operations and clinical quality. Because clinical trials are so data- and documentation-intensive, manual, paper-based processes are simply not effective. Digital systems can create efficient, consistent, and well-managed clinical processes that lead to successful trials. By digitizing, automating, and connecting all documents, the right tools can help orchestrate the management of site protocols, SOPs, and reporting across sites to accelerate trials while improving alignment.

A lack of transparency in clinical research has serious implications not only for patients, but also for providers, stakeholders, investors, and more. Failure to publish trial results is an ethical violation and withholding findings after individuals have participated in trials is a violation of a researcher’s responsibility to those participants. Most importantly, a lack of clinical trial transparency can leave patients and their providers with an incomplete picture of a treatment’s benefits and risks. The inefficiencies caused by a lack of transparency can also lead to unnecessary health system spending on ineffective or even harmful therapies.

While horrifying to witness it unfold, the Theranos saga is an outlier among ethical companies. In fact, many tech and life sciences companies have best practices already in place that other startups can and should learn from. For example, by prioritizing digitization, transparency, and collaboration, and regularly interacting with and getting feedback from customers, vendors, peer reviews, partners, and other third parties, life sciences companies have an opportunity to accelerate their products’ time to market, all while ensuring safety and continual compliance. The key is remembering that companies that play by the rules and prioritize transparency only stand to benefit and, ultimately, win!

Contributed Commentary by Matt Lowe

Aligning with the industry requirements has always been a priority for organizations. En route, they are heavily relying on revolutions that can help them stay ahead of the competition. One such revolution is Industry 4.0 – an amalgamation of pathbreaking technologies like industrial internet of things (IIoT), big data, artificial intelligence (AI), etc. The industry 4.0 has automated and optimized companies’ business processes and business models.

As industries across the world reaping the benefits of Industry 4.0 and its technologies, the pharma industry has taken a nimble step towards embracing and adopting the change commonly referred as Pharma 4.0. The move is aimed at digital transformation of two most important areas of pharma, namely, product development and regulatory operations.

Product development: Using traditional approaches for manufacturing medicinal products is an arduous task. Every step must be reviewed from time-to-time and the process must always be closely monitored to ensure the safety and efficacy of medicinal products. In such cases, it is a viable idea to monitor such processes with the help of advanced tools. The entire facility can be functioned from a single interface with minimal human intervention, i.e. by virtually connecting all the equipment with Pharma 4.0 technologies such as, IoT and Cloud.

Regulatory Operations: The data collected during research, clinical trials, product development, and post-market surveillance often remains disparate. When put together, without a right means to analyze the entire data from various perspectives, the results can either be inconclusive or be ambiguous. There, Pharma 4.0 comes into picture with big data analytics that implement algorithms to sum up clusters of data and to analyze it in less time.

Pharma manufacturers are willing to simplify their manufacturing processes and streamline regulatory operations. But do all the technologies of Industry 4.0 suit the needs of the pharma industry? Apparently not. Only a few of them, as listed below, fit the required criteria.

  1. Big data
  2. Smart factory
  3. Internet of Things (IoT) and cloud computing
  4. Artificial intelligence (AI)
  5. 3D Printing

Pharma 4.0: functionalities in focus

Pharma 4.0 is here to help the medicinal product manufacturers to evolve and become more efficient and at the same time to reduce the costs. But in what way? Which parts of regulatory operations can they be applied to?

  1. Drug research and development

Pharma companies rely heavily on innovation, and research for drug development. Companies are turning towards new revolutionary digital capabilities to reduce the time spent on R&D and boost their productivity. In such scenarios, AI-powered dashboards can help companies to keep track of the latest updates from the health authorities and comply accordingly.

As is well known, in the early stages of drug development,clinical data from public repositories is collected to analyze the history of proposed drugs’ ingredients. With machine language and deep neural networks, the advanced extensions of AI, such data can be utilized to derive insights on possible effectiveness/risk/benefits of a new compound. They allow manufacturers to enhance the nature of the human study and their decision-making while optimizing their workflow. In a way, stakeholders can identify the patterns and nature of patients to develop more customer-centric products and can bank upon less chances of failure and increase the cost efficiency.

  1. Clinical research

With a large number of resources involved in clinical research and trials, manufacturers should work upon developing statistical analyses plans and protocols. Apart from this, there are several documents which demand ample amount of time for analysis. With the help of AI-based tool integration, all these processes can be streamlined and expedited with minimal errors. AI-powered tools help researchers to go through research documents and extract necessary data with utmost accuracy within the time required. They can help in analyzing clinical information in real-time to ensure compliance while compiling, validating and submitting clinical trial data.

  1. Manufacturing

Health authorities across the world are emphasizing on implementing continuous manufacturing process by applying concepts of smart factory which make the process more connected, flexible, smart and precise. With the continuous process, manufacturers would not have a need to stop the manufacturing process in between for evaluation. This reduces the overall downtime of the process and also the human errors. This shift is helpful for manufacturers who are catering to the need of personalized medicines.

Pharma 4.0 assists manufacturers to minimize consumer risk and increase process optimization by statistically analyzing data with the help of big data. The insights drawn from the data can help manufacturers make necessary changes to the manufacturing process to achieve the desired level of product quality. It helps them to follow the manufacturing best practices.

  1. Quality management

The Pharma 4.0 technologies have the capability of transforming each and every function of the value chain. They allow manufacturers to rely solely on results obtained from the real-time data. Digitization will help manufacturers to ensure better quality and compliance while reducing human errors. For example, for publishing and submissions, companies have become paperless and are relying heavily on electronic records and electronic dossier submissions. With Pharma 4.0 technologies, they are assured of data integrity is maintained across the life cycle.

Challenges in adoption

Though the revolution of Pharma 4.0 is set to create limitless opportunities, there are challenges for companies to overcome.

  1. Unclear regulations for new-age technologies

Pharma 4.0 seems relevant and advantageous for both manufacturers and data reviewers, but there is still a vacuum in terms of regulating these technologies. While some health authorities are taking quick measures to establish the standards, others are waiting for regulated markets’ reflections.

  1. Lack of skill set

Pharma 4.0 requires an extensive technical skill set to carry out operations efficiently. The workforce to be deployed should possess knowledge with respect to Regulatory aspects and the technological improvements as well. As a radical improvement in the knowledge is necessary to sustain the revolution, organizations are required to build teams that are dynamic to adopt the technological transformations.

  1. Data integration

One of the main concerns for pharmaceutical companies is maintaining data integrity. While many companies have started using technologies for electronic conversions and paperless submissions, some are lagging behind with the legacy technologies integrated. Without the electronic version of data sets, collating and migrating data on to virtual platforms will become a challenge for companies, which in turn will lead to difficulty in comprehensive data access and assessment.

Conclusion

The pharma industry is on the verge of a radical change. Across clinical trials, manufacturing processes, technology integrations, and ever-evolving regulations, the industry is in need of complete transformation.

By adopting new-age technologies, companies can streamline their processes, increase productivity, accelerate their regulatory processes and reach the global markets in an expedited, cost-effective, and compliant way. But the regulation question prevails. How regulated are these technologies? While some of the global health authorities are taking considerable measures to regulate Pharma 4.0 technologies, a few are still considering their viability. Sooner or later, however, they will be the future of the pharmaceutical

A great succes it was for our 2-day GLP Training at Darwin wetenschapspark, Niel. This in close collaboration with Co-valent (vormingsfonds PC 116 & 207).

The pharmaceutical quality control laboratory is one of the most important functions in drug manufacturing and control. This will bring the participants an overview of the activities and responsibilities of a QC laboratory in drug manufacturing sites. The main intent of this course is to give trainees insights on the processes, methods & requirements specific for quality control labs.

De volgende open training sessie is onze 3-daagse Contaminatie Controle Training. Deze zal in Darwin wetenschapspark te Niel doorgaan. Wederom in samenwerking met Co-Valent. Onze opleidingen binnen onze Q-Academy zijn “gratis” beschikbaar via Co-valent: Co-valent biedt GRATIS opleidingen aan voor ondernemingen die behoren tot de life science sector – paritair comité 116 (arbeiders) of 207 (bedienden).

Hierbij een overzicht en de nodige links om u in te schrijven:

16, 17 & 18 December 2019 DAG 1 – Contaminatie controle in cleanrooms – Algemeen Niel
DAG 2 – Contaminatie controle in cleanrooms – Contaminatie Controle Grade D+C Niel
DAG 3 –  Contaminatie controle in cleanrooms – Contaminatie Controle Grade A+ B Niel

Quality is nonnegotiable in the medical field…

When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.

While medical devices in years past may have meant items like stethoscopes or blood pressure cuffs—and these haven’t gone away—a number of innovations in the medical industry such as stents and pacemakers require extremely high levels of quality.

As the devices themselves continue to evolve, so do the regulations surrounding them. Ensuring compliance is never easy, but in the medical device field, it may have gotten a little simpler. Changing medical device manufacturing audits is a multi-year process, but it’s going on now. Medical device manufacturing is an increasingly complex field with one aspect—the audit program—now aiming to be less complicated.

The Medical Device Single Audit Program (MDSAP) is a new program that simplifies the audit process. According to the FDA, “The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.”

In other words, one audit can do more. The site goes on to explain that the program allows medical device manufacturers to be audited once for five different medical device markets: Australia, Brazil, Canada, Japan and the United States. Companies are now in the midst of this implementation. And it seems that the program has been well-received so far.

On the FDA site, there are testimonials from industry attesting to the benefits of the MDSAP: “With a Mission to improve the quality of life for patients, prevent progression of chronic diseases, and reduce overall healthcare system costs, ResMed is committed to driving innovation and efficiencies across all aspects of our business. The MDSAP program has allowed us to consolidate the global regulatory assessment process across multiple international locations, reducing internal costs while increasing the overall predictability of these efforts across our global footprint. By minimizing disruption to our business, we can focus on delivering the safest, most effective and technologically advanced products possible.”

Advanced products deserve more advanced audits. There are no shortcuts to good quality, but repeatedly proving your compliance to quality programs can take away from this mission. So how did this program come about? As discussed on the FDA site, the International Medical Device Regulators Forum (IMDRF) noted that a global approach to auditing and medical device manufacturing could improve their safety on an international level. Harmonizing the medical device manufacturing field could be a boon to industry as well as consumers. Making it easier to provide medical devices on a global scale, with fewer audits along the way, benefits manufacturers and the consumers they serve.

In other words, this program aims to make it easier for manufacturers to offer their devices to a worldwide market. As stated on the FDA site, the international partners participating in the MDSAP include: Therapeutic Goods Administration of Australia; Brazil’s Agência Nacional de Vigilância Sanitária; Health Canada; Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency; and The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers.

BSI, one of the auditing organizations that have worked with the new program, say that feedback about the program’s benefits has been “overwhelmingly positive.” According to the company, “A Single Audit by Auditing Organizations would:

  • minimize medical device manufacturer disruptions due to multiple regulatory audits
  • provide predictable audit schedules (agenda with opening and completion dates)
  • benefit patient health and patient access with ease of entry to multiple markets
  • leverage regulatory resources
  • incorporate ISO 13485 assessment
  • requirements, including Australia, Brazil, Canada, Japan and U.S.
  • reduction in time and resource dealing with findings from multiple audits
  • reduction in the cost of audits in comparison to independent audits
  • improved transparencies in the industry.”

While outside forces do play a large role in the audit process, having good audit processes is something that you can control. Being prepared for the audits—no matter which program you are using—may come down to the right tools. One critical one is audit management software. In particular, being able to streamline audit tasks and centralize audit data is important. With the right tools, you can gain better visibility into audit performance as well as identify potential trends. Maintaining a strong record history becomes easier, as does maintaining compliance with FDA 21 CFR Part 11.

Manufacturing medical devices is an important mission, one that potentially benefits all of us. When your doctor suggests a new device, it’s comforting to know that the device was made to the highest standards. Fewer audits potentially means more time for innovative ideas. The next medical breakthrough could be just around the corner.

by Michelle Bangert

A great succes it was for our 2-day Validation Training at Darwin wetenschapspark, Niel. This in close collaboration with Co-valent (vormingsfonds PC 116 & 207). This training gives trainees a broad background in Validation within the life science industry.

Practical training given by an expert with experience in various domains. The participants will gain sufficient background and tools to work with.

This course is designed to explain why regulatory agencies require Validation, as well as the consequences of failing to validate processes & systems.  Attendees will learn where & how validation and change control fits in to the Quality management system & regulatory filing.  The course will provide a walk through the different validation steps, the overall validation methodology and its key deliverables. Attendees will discover which systems require validation – and which do not.  They will also learn how to safeguard your Quality through change control.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

For the past few years, the injectable pharmaceuticals market has faced major challenges, reflected in ongoing shortages of critically important products (1). As governments cut healthcare spending to reduce costs (2), patients are demanding more personalized delivery methods such as auto-injectors (3) and regulators, sensitized by serious compliance problems in the past (4), are increasing scrutiny of aseptic filling and manufacturing operations (5).

Adapting to these changes, while improving product quality, requires manufacturing processes that are as efficient, flexible, and compliant as possible.

Fortunately, the automotive, electronics, and aerospace, have faced and overcome challenges like this in the past, leaving behind a legacy of best practices and holistic approaches, often referred to as Operational Excellence (OpEx) methods (6), designed to reduce waste, improve efficiency, and reduce error. Over the past two decades, more pharmaceutical companies and their contract partners have adopted these practices to the specifics of the pharmaceutical industry (7). Many OpEx terms, such as gemba(the place where the truth will be found, i.e., the laboratory and production floor) are in Japanese, and came from Toyota, whose managers had to respond to Toyota Kata. Other improvements came from sources as diverse as Motorola engineer Bill Smith, who is credited with inventing the Six Sigma methodology, Henry Ford, and J. Edwards Deming (8).

In 2015, recognizing the challenges occurring in the industry, the contract development and manufacturing organization (CDMO) Vetter implemented a pathway called “Production Excellence” (ProdEx), which selected the most relevant OpEx concepts and applied them to the company’s operations. Designed to take a holistic approach, ProdEx aims to simplify and streamline processes, improve efficiency and effectiveness, and continuously reduce human error in all production processes. The desired goals include improved product quality, harmonized processes, better operational equipment efficiency (OEE), and, ultimately, better customer satisfaction.

The ProdEx method

Vetter has 2500 production employees, so an end-to-end process was essential. The company appointed a team of internal production experts to lead the effort, with the goal of achieving sustainable results. The ProdEx team handles the launch and implementation of system measures and coordinates subsequent steps designed to further improve processes.

Taking this approach and having the effort led by internal domain experts allows for a holistic approach for all production sites, and improves communication and outreach with other departments. The team’s first assignment was to define relevant, overarching issues pointed out by senior production executives. This enabled the identification of processes whose outcomes were already on track, as well as areas where improvement was needed.

This first step in the project defined the following five pillars, or areas where activities were focused:

  • Human factors
  • Customers
  • Machines
  • Processes
  • Material

Focusing on these pillars (see Figure 1) allowed team members to develop a comprehensive catalog of performance improvement measures in each area.

Figure 1. The ProdEx method incorporates five different areas of relevance.

To achieve the best possible results from the implementation of these measures, the company combined a large spectrum of known process optimization methods, such as aspects of ‘Lean Management’, ‘Six Sigma’, ‘Statistics’, ‘Kanban’, and ‘Gemba-Walks’, according to the focus of the individual measure. Additionally, self-developed methods like a ‘Keep-It-Simple-Approach’ were also implemented. Regular, cross-divisional communication among all involved areas was also instituted to discuss new impulses, evaluate implemented measures and define any potential follow-up measures.

he team used a Vetter-specific “Keep It Simple” approach. Communication practices were established to enable ongoing communication between employees from different functional groups within the operation to discuss new ideas, evaluate steps that had already been implemented, and define any potential follow-up measures.

Results of ProdEx contribution

So far, these efforts have led to improvements in various fields such as automation, process improvements and the avoidance of financial investments.

Reduction of waste. The team identified processes that added little to no value, and they were systematically eliminated. Targets included administrative processes as well as additional steps in daily routines. In total, more than 200 processes from shop floor to management were identified to get rid of or to simplify, e.g., quality documentation forms with redundant information. Combined, these small changes added up to a considerable improvement potential.

The effort allowed for a reduction ranging from 10 minutes to two hours of total work time per day per affected employee. This not only reduced the burden for employees in production, but also for those from surrounding work areas involved in a cross-divisional processes.

Installing a mobile application to reduce downtime by identifying and adjusting micro-malfunctions. Adigital micro-malfunction management system, programmed internally via an app, reduced downtime for aseptic filling, packaging, and automated visual inspection. In addition to using the existing system, called Machine Standard Malfunction Protocols, designed to identify larger-scale malfunctions, production staff can now use tablet devices to record small stops of less than five minutes on each machine (see Figure 2). The interruptions are then digitally processed on a web-based server for each individual machine of a production line. As a result, data collection is transparent and allows for correcting dependencies between interruptions at separate machines as well as the recording of the sum of small stops.

Figure 2. Implementing a micro-malfunction management system, in addition to the existing malfunction-gathering system, production employees use tablets permanently installed at each machine to record so-called small stops. This reveals any dependencies between individual machines as well as the total sum of the malfunctions.

Improvements were made quickly. Using this approach, overall production capacities increased by up to 16% per line, product availability was further improved, and quality-relevant deviations were minimized due to the higher technical availability of in average +4%. This measure also had further positive effects on product quality such as less machine interventions in critical areas. Process safety was increased and product downtimes at room temperature declined, as did the sum of deviations from current good manufacturing practices (cGMPs).

Reducing human error using poka yokeand other approaches. A holistic program structure was developed based on process, organization, and human factors to reduce errors. It uses Poka-Yokeprinciples to design processes, and incorporates the development of a code of conduct in production as well as the analysis and evaluation of each human error regardless of whether it has led to GMP deviations or not (see Figure 3). Developed by the US National Aerospace and Space Administration (NASA), and adapted for the Vetter usage, the approach Crew Resource Management (CRM) shares knowledge about topics such as teamwork, awareness of responsibility, and clear communication. Within three years of adopting the program, Vetter’s human error rate dropped by 15%.

 

Figure 3. Pharmaceutical companies are considered high reliability organizations. Human error avoiding programs help employees reduce the rate of errors.

Looking into the future, the ProdEx team is planning further activities with its IT and other departments as part of an overall Industry 4.0 initiative, which will include such efforts as Industrial Internet of Things (IIoT), digital process support on production lines, and big data assessment to improve processes. Continuous improvement is the process.

Optimization and quality

Overall, ProdEx has helped Vetter improve production flexibility and efficiency, at a time when the company has seen a strong increase in headcount, production quantities, and market growth, as well as more stringent demands for product quality from customers and regulatory authorities. Initiatives like this show that it is possible to optimize quality and processes, simultaneously. Results emerging from the ProdEx process contribute to the company’s “Fit for Future” program which is embedded in the overall Vetter Optimization System.

A pharmaceutical industry standard

In today’s pharmaceutical industry, process optimization offers huge potential, and the ProdEx process has begun to drive continuous improvement at Vetter’s Production.

What the company has learned in the process is how essential it is to rely on internal teams to drive change. Only internal experts can deliver results based on the depth of their knowledge and expertise.However, information exchanges with other high-regulated industries such as aerospace and with academia, especially in the area of digitization and Industry 4.0-related work, can also lead to significant progress.

In this context, the saying by German industrialist Philip Rosenthal applies well: “Those who don’t believe they can get better have stopped being good.”

References

1. R. Aghjayan, “FDA: Early 2019 Drug Shortages Announced,”Clinicaladvisor.com, April 8, 2019.
2. American Academy of Actuaries, “Prescription Drug Spending in the US Healthcare System,” March, 2018.
3. C.H. Dubin, “Injection Devices: As Self-Injection Grows, Drug Delivery Gets Smarter,” Drug Development & Delivery18 (6) 50–64 (2018).
4. GaBi, “FDA strengthens and modernizes inspections for sterile injectable drugs,” gabionline.net, Nov. 23, 2018.
5. M. Sony, “Implementing Sustainable Operational Excellence in Organizations: an Integrative Viewpoint,” Production & Manufacturing Research7 (1) 67–87 (2019).
6. BTOES Insights, “What is Operational Excellence?” insights.btoes.com, accessed May 29, 2019.
7. T. Hessing, “History of Lean,” sixsigmastudyguide.com, Nov. 11, 2015.
8. D. Bellm, “Operational Excellence in the Pharmaceutical Industry—An Architecture for Emerging Markets,” PhD Dissertation (University of St. Gallen, Switzerland, October 2014).

Volgende opleiding op maandag 2 december 2019; “GLP labo activiteiten binnen GMP life science productiebedrijven”. De sessie gaat door in het Darwin wetenschapspark te Niel. Deze opleiding binnen onze Q-Academy zijn “gratis” beschikbaar via Co-valent: Co-valent biedt GRATIS opleidingen aan voor ondernemingen die behoren tot de life science sector – paritair comité 116 (arbeiders) of 207 (bedienden).

Deze training is een aanvulling op de GMP/QMS-training en geeft meer achtergrond voor projectingenieurs en leidinggevende binnen GMP QC labo’s.  We bieden een regulatorische en praktische kader van het behandelen van stalen, uitvoeren en documenteren van QC testen en de daarbij behorende kwaliteitssystemen zoals validatie/kwalificatie, change control.  Daarnaast staan we ook stil bij transfers.

Schrijf je snel want de plaatsen zijn beperkt: https://www.co-valent.be/nl/details-formations 

According to the letter issued to Glenmark, the company “failed to adequately investigate more than 70 consumer complaints associated with punctures, cracks, and holes” in some of the topical creams and ointments manufactured at its Baddi facility.

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Glenmark’s investigations did not adequately address the scope and cause of these “serious” defects and evaluate other products with similar “manufacturing quality signals” or the same supplier, the FDA found.

The US Food and Drug Administration’s (US FDA), in a warning letter to Glenmark Pharmaceuticals earlier this month, said that the generic drug maker failed to thoroughly investigate issues related to the quality of some of its products.

According to the letter issued to Glenmark, the company “failed to adequately investigate more than 70 consumer complaints associated with punctures, cracks, and holes” in some of the topical creams and ointments manufactured at its Baddi facility.

Glenmark’s investigations did not adequately address the scope and cause of these “serious” defects and evaluate other products with similar “manufacturing quality signals” or the same supplier, the FDA found.

“In your response, you stated that the root cause for the complaints was improper ‘handling by folding and refolding of the (redacted)’ by consumers. In addition, you stated that because the complaint rate is insignificant, there is no risk to marketed batches,” it stated, adding over 50 complaints were closed “without” a plan to prevent these issues in the future. “Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,” it told the firm.

Glenmark’s investigation of and response to “multiple” complaints of “grittiness” of one of its topical creams was also “inadequate”. In July, the firm recalled an undisclosed number of batches of its mometasone furoate cream (used to treat various skin conditions) from the US over their grittiness — an “ongoing formulation issue since 2010” also flagged in previous inspections.

“In your response to the most recent inspection, you stated that the product grittiness issue was remediated during product reformulation in November 2018. Your response is inadequate. You did not provide sufficient data to demonstrate the robustness of the new formulation,” stated the warning letter.

In a separate warning letter on October 8, the US regulator told Torrent to “immediately and comprehensively” assess its global manufacturing operations to ensure it conformed to FDA requirements. “Repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it told Torrent. The firm had failed to “thoroughly” investigate unexplained discrepancies or failures of products made at its Indrad facility, including its high blood pressure drug losartan potassium and hydrochlorothiazide tablets. It had closed “multiple” out-of-specification (OOS) investigations “without assignable root cause” or “adequate scientific justification” of these causes. “Despite the inadequate OOS investigations, your firm disregarded initial failing OOS results and released batches based on retested results,” the FDA told the company.

Issues were also raised for Torrent’s Dahej facility during an inspection in March, the regulator said. Glenmark and Torrent had notified the BSE earlier this month of the warning letters they had received. Both firms said that the letters would not have an impact on their operations, and they were working to resolve the issues.

Written by Prabha Raghavan | New Delhi