TUV Limited’s Post

 #Quality by Design (QbD) and Root Cause Analysis: A Powerful Combination Quality by Design (QbD) is a well-established approach used in pharmaceuticals, manufacturing, and other industries to ensure product quality throughout its lifecycle. While #QbD isn’t a direct root cause analysis method, it can significantly enhance your approach to identifying and addressing issues.  How Can QbD Enhance Root Cause Analysis? Define Critical Quality Attributes (CQAs): Start by identifying the key quality characteristics of your product or process. These attributes directly impact safety, efficacy, or performance. Risk Assessment: Use tools like Failure Mode and Effects Analysis (FMEA) or Hazard Analysis and Critical Control Points (HACCP) to assess risks. This helps you pinpoint potential failure modes and their impact. Design of Experiments (DoE): Apply DoE techniques to systematically explore process variables and their effects on CQAs. This can reveal hidden factors affecting quality. Root Cause Analysis (RCA): When issues arise, follow the steps you mentioned (Fishbone Diagram, 5 Whys, and Brainstorming) to identify root causes. QbD principles can guide this analysis. Continuous Improvement: Implement corrective actions based on root cause findings. Monitor and adjust the process iteratively to maintain quality. Remember, QbD complements root cause analysis by emphasizing proactive prevention and robust process design. #TUV_Limited

At Independent Solutions, we're committed to providing solutions that not only meet the stringent requirements of the Life Sciences industry but also optimise efficiency and reduce waste. That’s why we're proud to offer Lean Validation services, designed to streamline your processes and enhance value. 🔹 Lean Validation focuses on eliminating unnecessary steps and focusing resources on what truly matters, ensuring compliance and operational efficiency. This approach not only speeds up the validation process but also significantly cuts costs, making it an ideal solution for projects of all sizes. 🔹 Our Lean Validation Services Include: - Tailored validation strategies that align with your specific needs. - Comprehensive support from our expert team, ensuring that your projects meet all regulatory requirements without any excess. - Continuous improvement practices to keep your operations lean and competitive. Learn more about how Lean Validation can transform your projects by visiting: https://lnkd.in/eewsnqnT Let us help you make your validation processes more efficient, cost-effective, and compliant. #IndependentSolutions #LeanValidation #LifeSciences #Compliance #OperationalEfficiency #Ireland

What is Process Validation? Process validation is a step-by-step procedure designed to ensure that a manufacturing process can consistently produce quality products. It is performed by a validation team led by the quality assurance head of manufacturers in the industry. Generally, process validation is done before releasing a new product, when applying any change on an existing product, and for periodically verifying the process. Established at the onset, a protocol should specify how the validation process will be carried out, including the parameters to be monitored, the samples to be taken, and the results to be accepted. #processvalidation #pharmaceuticalindustry #foodandbeverage #qualityassurance #qualitycontrol #qms #cleaningvalidation

Hello LinkedIn Community Completing the Good Manufacturing Practice (GMP) online course isn't just about earning a certificate – it's about gaining invaluable insights and skills that can transform the way we approach manufacturing. The course is rich with the following valuable insights ✅ Quality Risk Management ✅ Deviations, Root cause analysis (RCA) , Corrective and Preventive action (CAPA) ✅ Validation and Qualification of facilities, equipment and Utilities ✅ HVAC and Water Systems This Course represents an extra tool and it serves as a cornerstone for excellence and success in engineering roles within the highly regulated and quality-driven pharmaceutical sector. #GMP #OnlineLearning #ProfessionalDevelopment #ManufacturingExcellence #ContinuousImprovement

There is definitely a process and needs to be followed. A good project manager can keep timelines progressing and milestones and target dates met. When decision makers in the process don't understand or don't believe in this process because their backgrounds are in marketing, finance, etc. and not manufacturing or quality they try to drive the final date before all the predecessor steps are complete and it ends up taking longer because key steps were missed or performed incorrect.

At mdi, quality is integral to every step of our process. That is why we embrace Quality by Design (QbD) in our product development and manufacturing. QbD is a proactive approach that ensures high quality outcomes through statistical, analytical, and risk-management methodologies during design, development, and manufacturing phases. A key goal of QbD is to identify, explain, and manage all Quality Target Product Profiles, Critical Process Parameters, Critical Quality Attributes, variability, and mitigate risks at every stage. QbD allows us to build quality into our products from the start rather than relying solely on end-product testing. QbD also guarantees that the final products consistently meet predefined specifications. At mdi, exceeding expectations is our mission, and QbD is fundamental to that commitment. It is also a powerful tool to drive innovation.   Want to learn more about how mdi leverages QbD? Check out our blog article for an in-depth exploration: https://lnkd.in/ghC83t2A #QbD #innovationwithmdi

🔬🆕✅ I am happy to share that I have completed the "Medical Device Process Validation" Training Course! This achievement is a milestone in my professional development, and I am prepared to use the skills and knowledge I have acquired 🌟 🔬🩺 It was a great learning about Medical Devices, training me in depth on Process Validation in the life sciences industry. MUCH MORE TO COME! 🔜 💡 The program's key takeaways: ✔ Types of Process Validation ✔ Process Validation Stages: User Requirements Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) ✔ Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) ✔ Process Capability: Capability Ratio Cp, Capability Index Cpk, Action Levels and Control Limits ✔ Design of Experiments (DoE), DoE Response, Factors and Levels ✔ Risk Management ✔ Regulations: ISO 13485, ISO 14971, FDA Regulations, Quality System Regulation (QSR) 21 CFR 820.75 ✔ Test Method Validation (TMV): Measurement System Analysis (MSA), Repeatability and Reproducibility, ANOVA ✔ Documentation: Validation Master Plan (VMP), Change Control #MedicalDevices #ProcessValidation #DQ #IQ #OQ #PQ #URS #DoE #RiskManagement #TestMethodValidation #ISO13485 #ISO14971 #FDA #Regulation #Standards #ContinuosLearning

Join us for the Best Practices for an Effective Cleaning Validation Program, our final course of 2024! In this course, you will learn about the latest industry practices, identify potential pitfalls, and discover effective methods for establishing a cleaning validation program. The course emphasizes a risk-based approach and covers essential topics like developing policies, master plans, and study content, as well as validation maintenance and lifecycle aspects. Real-world examples will illustrate concepts across various product types and dosage forms, including sterile and non-sterile products. Course Details: 📅 Date: December 17 - 19, 2024 🕛 Time: 12:00 to 5:00 ET / 9:00 to 2:00 PT 👨🏫 Instructor: Steven Weitzel If you are involved in cleaning validation, including personnel from validation, engineering, operations, quality control, quality assurance or a management team that interacts with one of these groups then this is the course for you. Visit our website to learn more and register. https://cc94.co/3VYNBfV #CleaningValidation #LifeSciences #ProfessionalDevelopment

Why is validating your BINDER equipment essential for Good Manufacturing Practice (GMP)? Ensuring consistent product quality and reproducible testing processes is vital for labs and production facilities following GMP or GLP standards. This means conducting and meticulously recording numerous unit tests to provide thorough evidence. BINDER can significantly reduce the workload associated with qualifying and validating units. Understanding IQ, OQ, and PQ: IQ – Installation Qualification certifies correct unit installation according to customer specifications, documented thoroughly. OQ – Operational Qualification ensures the unit functions correctly when unloaded, with tests available in the qualification folder. PQ – Performance Qualification assesses the unit's functionality under loaded conditions, meeting customer-specific requirements through collaborative test definition. Benefits of partnering with BINDER: Reproducible Data: Get reproducible data for your BINDER unit, customized to your processes and standards. BINDER Expertise: Benefit from our expertise throughout the validation and qualification process, ensuring the best outcomes. Qualified Specialists: Our validation and qualification processes are handled by experienced specialists, ensuring precision and reliability. On-site Validation and Qualification: We conduct validation and qualification procedures on-site for your convenience and efficiency. Comprehensive Range of Services: Our qualification folder includes comprehensive documentation for customer-performed validation, including IQ/OQ checklists, unit schematics, and quality management (QM) information. We also offer ISO 9001 certification, BINDER software IQ/OQ, and optional light photometry testing. Partnering with BINDER for your equipment validation and qualification not only ensures GMP compliance but also boosts efficiency, reliability, and quality assurance in your processes. Emphasizing accuracy and adherence to protocols is paramount to conforming to ALL standards. #BINDERInc #IQOQPQ #bestconditionsforyoursuccess