🖋 It was a slow week for Warning Letters, with only two to choose from. 1️⃣ was yet another hand sanitizer manufacturer that did not understand that these products are considered drugs. As usual, they: ✔ Failed to establish a Quality Unit with any authority ✔ Didn't validate their water systems ✔ Didn't conduct incoming or final testing. We're starting to wonder whether any hand sanitizer manufacturer is in compliance. 🤔 👉 https://lnkd.in/giRSJ3Zs 2️⃣is interesting as it involves a type of entity under the Center for Biologics Evaluation & Research (CBER) we rarely hear about - a tissue bank, specifically an eye bank. Although the requirements for these operations are very different from what we're used to for devices and drugs, the underlying concepts are similar: registration, good practices, reporting, labeling, etc. 👥 In this case, donors could be considered equivalent to suppliers. This means that there are requirements for properly selecting and evaluating eligible donors. The facility's procedure for donor eligibility didn't sufficiently demonstrate a risk-based approach. They failed to identify clear "red flags" that should have invalidated many donors even though the information needed for a clear evaluation was available in every case. 🛑 Their response didn't help, as it demonstrated a lack of basic risk management knowledge. Setting the probability threshold at 100% doesn't address the role of probability of occurrence in risks. Then, there was a half-hearted attempt to appease the FDA by updating the procedure but not addressing the root causes. Essentially, they doubled down on their existing methods by adding more misguided rationale without attempting to refine the methods. 👉 https://lnkd.in/gcDh7ryX It's always hard to say what went wrong just by trying to read between the lines of a Warning Letter and reviewing their personnel on LinkedIn. As experienced auditors, we would likely start by looking at leadership and management responsibility relative to establishing an effective quality culture. Even when internal resources are competent, they can become unintentionally biased or complacent over time. This is another good reason to engage external experts who can help you see what you may have become blind to. As we always recommend, engage consultants before there are problems. Organizations with truly strong quality cultures understand that they must constantly challenge themselves on whether they're as good as they think. QRx Partners is always ready to give you an honest assessment. 🤝 #QRxPartners #QRxInforms #MLV #FDA #WarningLetters #InadequateResponse #CBER #Compliance #Regulatory #FDAcompliance #HereForYou #QualityCulture
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Experienced Leader in Quality Systems Implementation & Management (CMQ/OE, CMDA, RAC-US, CMIIC)
This week we cover a different type of Warning Letter; one focused on a tissue bank. Although there are a completely separate set of regulations in this space, the underlying concepts are pretty much the same as for devices and drugs. #QRxPartners #QRxInforms #MLV #FDA #WarningLetters #InadequateResponse
🖋 It was a slow week for Warning Letters, with only two to choose from. 1️⃣ was yet another hand sanitizer manufacturer that did not understand that these products are considered drugs. As usual, they: ✔ Failed to establish a Quality Unit with any authority ✔ Didn't validate their water systems ✔ Didn't conduct incoming or final testing. We're starting to wonder whether any hand sanitizer manufacturer is in compliance. 🤔 👉 https://lnkd.in/giRSJ3Zs 2️⃣is interesting as it involves a type of entity under the Center for Biologics Evaluation & Research (CBER) we rarely hear about - a tissue bank, specifically an eye bank. Although the requirements for these operations are very different from what we're used to for devices and drugs, the underlying concepts are similar: registration, good practices, reporting, labeling, etc. 👥 In this case, donors could be considered equivalent to suppliers. This means that there are requirements for properly selecting and evaluating eligible donors. The facility's procedure for donor eligibility didn't sufficiently demonstrate a risk-based approach. They failed to identify clear "red flags" that should have invalidated many donors even though the information needed for a clear evaluation was available in every case. 🛑 Their response didn't help, as it demonstrated a lack of basic risk management knowledge. Setting the probability threshold at 100% doesn't address the role of probability of occurrence in risks. Then, there was a half-hearted attempt to appease the FDA by updating the procedure but not addressing the root causes. Essentially, they doubled down on their existing methods by adding more misguided rationale without attempting to refine the methods. 👉 https://lnkd.in/gcDh7ryX It's always hard to say what went wrong just by trying to read between the lines of a Warning Letter and reviewing their personnel on LinkedIn. As experienced auditors, we would likely start by looking at leadership and management responsibility relative to establishing an effective quality culture. Even when internal resources are competent, they can become unintentionally biased or complacent over time. This is another good reason to engage external experts who can help you see what you may have become blind to. As we always recommend, engage consultants before there are problems. Organizations with truly strong quality cultures understand that they must constantly challenge themselves on whether they're as good as they think. QRx Partners is always ready to give you an honest assessment. 🤝 #QRxPartners #QRxInforms #MLV #FDA #WarningLetters #InadequateResponse #CBER #Compliance #Regulatory #FDAcompliance #HereForYou #QualityCulture
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In the world of pharmaceuticals, ensuring product quality and patient safety is paramount. 💊🏥 Pharmaceutical risk management is more than a practice; it's a regulatory expectation. Regulatory authorities like FDA and EMA demand robust risk management systems for quality assurance. Pharma manufacturers face a complex risk landscape – internal (human errors, outdated tech) and external (regulatory shifts, market changes) risks. Managing these risks is key to success and resilience. 🔍 Watch our video below as we dive into a real-world case study highlighting risk management in action. Discover how we navigate internal and external risks to safeguard product quality. Curious for More? 💪 Join us for an exclusive Pharma Webinar with the remarkable Simone Ammons from QuneUp on September 19, 2023, at 4:00 PM - 5:30 PM CET Berlin. 🕓 Learn how to navigate those pesky external risks like supply chain disruptions and internal challenges such as contamination and equipment breakdown. 💡 In this thrilling webinar, you'll: 🔹 Discover how to dance with risk and make informed decisions like a pro! 💃 🔹 Master the art of de-risking your processes for smooth sailing! ⛵ 🔹 Get exclusive tips to future-proof your operations against unexpected curveballs! 🚀 Our webinar partner this time is QuneUp™, the superhero of data-driven software tools that slashes equipment downtime and boosts productivity. 🤖⚡️ 🔗 Register now: https://rfr.bz/l6idttp Let's show risk who's boss in the pharma world! See you there, superheroes! 💥💊 #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing https://rfr.bz/l6idttp
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Director at Qualistery | Pharma Events Championing Quality & Operational Excellence in the Industry | Offering exclusive webinar speaking and sponsorship opportunities to GxP suppliers to enhance their brand and reach 🚀
In the world of pharmaceuticals, ensuring product quality and patient safety is paramount. 💊🏥 Pharmaceutical risk management is more than a practice; it's a regulatory expectation. Regulatory authorities like FDA and EMA demand robust risk management systems for quality assurance. Pharma manufacturers face a complex risk landscape – internal (human errors, outdated tech) and external (regulatory shifts, market changes) risks. Managing these risks is key to success and resilience. 🔍 Watch our video below as we dive into a real-world case study highlighting risk management in action. Discover how we navigate internal and external risks to safeguard product quality. Curious for More? 💪 Join us for an exclusive Pharma Webinar with the remarkable Simone Ammons from QuneUp on September 19, 2023, at 4:00 PM - 5:30 PM CET Berlin. 🕓 Learn how to navigate those pesky external risks like supply chain disruptions and internal challenges such as contamination and equipment breakdown. 💡 In this thrilling webinar, you'll: 🔹 Discover how to dance with risk and make informed decisions like a pro! 💃 🔹 Master the art of de-risking your processes for smooth sailing! ⛵ 🔹 Get exclusive tips to future-proof your operations against unexpected curveballs! 🚀 Our webinar partner this time is QuneUp™, the superhero of data-driven software tools that slashes equipment downtime and boosts productivity. 🤖⚡️ 🔗 𝗖𝗹𝗶𝗰𝗸 𝘁𝗵𝗲 𝗹𝗶𝗻𝗸 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝘀 𝘁𝗼 𝗿𝗲𝗴𝗶𝘀𝘁𝗲𝗿! Let's show risk who's boss in the pharma world! See you there, superheroes! 💥💊 #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing
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Success and failure are usually separated by how much you know about the problem. Risk analysis’s greatest mistake is viewing risks as events. There is not much information in an event outside of an impact severity and a frequency of occurrence. The events usually form a noisy landscape of separated incidents. You can play with the statistics of their relative occurrence to correlate them, but you seldom generate any real understanding of what’s going on or how to prevent it. If you visualize risks as relationships between events. The vast majority of information about any risk is tied up in the connecting relationships called systems. Every connection has a probability of propagating an input event into an output event. By studying and understanding how the system works, its uncertainty, and the system’s failure modes, you can generally make a good estimate of how likely it will propagate one event into another. Some systems have a lot of information to work with while others have a great deal of uncertainty. The system information is seldom perfect, but it’s almost always much better than the information associated with guessing event frequencies, unless of course you cheat, like some do, and look at the system that produces the events. So, the next time you worry about a bad event, the first question should be what system produced the event and how much do you know about that system. https://lnkd.in/e3j8b8AZ #risk #riskanalysis #riskmangement #ich #ichq9 #iso #iso31000 #fda #qrm #pharmaceuticals #biopharmaceuticals #rera #riskbenefitanalysis #riskbenefit #medicaldevicerisks #medicaldevices
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Navigating nitrosamine risks? Nitrosamines pose complex challenges in pharmaceuticals. The reward? Ensuring product safety and efficacy. Welcome to Nitrosamine Life Cycle Management. This isn't about mere compliance. It's about strategy refinement, stringent risk assessment, and seamless project management. It's about upholding premier safety standards. The ICH M7 guidelines and Good Manufacturing Practice (GMP) are our navigation tools for genotoxic impurity risks. We're focused on public health protection. The journey? Not meant to be solo. We stand poised to partner, our expertise reaching beyond current regulations to anticipate future challenges. We don't just react, we shape the conversation. Imagine a partnership with aligned strategy, exceeding ICH M7 and GMP standards. Imagine the nitrosamine risk dissipated, leaving only trust in your product's safety. It's not a dream. It's our offer. It's our strength. Ready to redefine safety and efficacy together? Connect with us. Let's shape pharmaceutical history. #pharma #medtech #quality #gmp #compliance #regulatory #zamann
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Ensuring raw material integrity is vital for drug quality and safety. A risk-based approach to testing and specification setting ensures regulatory compliance and protects patient health. Our latest blog, authored by Bryan Abney, explores critical aspects such as risk assessment, tailored impurity testing, adherence to pharmacopeial standards, and effective supplier quality agreements. Read the blog: https://bit.ly/44UL2kS #PharmaceuticalManufacturing #DrugDevelopment
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To paraphrase Wittgenstein, one of the more important 20th century philosophers, the language of risks limits the world of risk analysis. The current set of regulatory guidance clearly stating that you should take risks seriously, thoroughly analyze and reanalyze them along with managing them in accordance with their impact is a no brainer. But the language defining a risk and the methods for how to understand, analyze, and manage risks is a wild assortment of conflicting lexicons trying to describe complex half-baked concepts, that includes slices of cheese and “top” events. Without simple, clear, and broadly effective risk analysis methods, the regulatory guidelines are little more than tomes babbling the obvious. The problem starts with an ambiguous definition of a risk as “the impact of uncertainty on an objective.” Sort of a hamburger with nothing between the buns. If you want to find the “beef,” try viewing a risk as “the impact of uncertainty on a mechanism, process or system that produces an objective.” Although the difference seems trivial, analyzing the uncertainty to a risk’s mechanism of action provides a much richer foundation for identifying, evaluating, and managing the probabilities of various uncertainties that impact achieving the risk’s objective. For a promising better language for understanding risks, see https://lnkd.in/e3j8b8AZ #risk #riskanalysis #riskmangement #ichq9 #iso31000 #fda #qrm #qmsr #pharmaceuticals #biopharmaceuticals #rera #riskbenefitanalysis #riskbenefit #medicaldevicerisks
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🌟 Unlock the Secrets of Risk-Based Thinking in Life Sciences! Dive deep into the dynamic world of risk management with Angelo Scangas and Bob Deysher from Quality Support Group, Inc. Explore cutting-edge strategies, practical tools, and industry insights to navigate risks while prioritizing patient safety and product quality. Elevate your expertise and gain a competitive edge in the thriving life sciences sector. Don't just manage risks—master them! 💡 #AlwaysKeepImproving #QSG #RiskManagement #LifeSciences #QualityManagement #PatientSafety #ProductQuality #RegulatoryCompliance #Pharmaceuticals #Biotechnology #MedicalDevices #HealthcareIndustry #RiskBasedThinking #ProfessionalDevelopment #IndustryInsights #BestPractices #CareerAdvancement
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Insightful #Presentation #Mitigating #Risk in #Cleaningvalidation 👇👇💯💯👇👇👇🎉🎉🎉 Download more than 1500 document related to #pharmaceuticalIndustry in #Pharmatalks community in #Telegram 👇👇👇👇👇👇👇 https://lnkd.in/eGYnkHeM #pharmacist #pharma #pharmacy #health
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Insufficiently defined problems remain essentially unsolvable until the gaps are filled with assumptions. For risks, the absence of a clear, universal understanding of how risks work combined with ambiguous methods and terminology makes consistently filling the gaps with meaningful assumptions virtually impossible. The results – chaos. As long as risks are primarily viewed and treated as events defined as “the impact of uncertainty on objectives” or “the combination of severity & probability of occurrence,” risk analysis will remain in chaos as analysts use a wide variety of tortuous methods, abstract terminology, and contradictory approaches desperately trying to fill in the gaps required to solve even simple risk problems. Risk events simply do not contain enough information to analyze much less manage a risk. Even with considerable frequency data, the information gap between a risk event and the relationships surrounding the event is so wide it cannot be filled without making many highly subjective assumptions. Without a complete realignment of the entire field or risk analysis from viewing risks as events to visualizing and analyzing risks as relationships between events, the chaos will continue. #risk #riskanalysis #riskmangement #ich #ichq9 #iso #iso31000 #fda #qrm #pharmaceuticals #biopharmaceuticals #rera #riskbenefitanalysis #riskbenefit #medicaldevicerisks
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Exec VP at Data Reduction Systems
3wThank you for continuing to provide this helpful information. Item 1 makes me wonder just how much (some of) these sanitizers do NOT do to, well, sanitize.