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

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

♦️What Are the Different Classification Types of Deviation?♦️ ☑️There are two main classification types of deviations: planned and unplanned deviations. ✔️Planned Deviation:- Planned deviations refer to pre-approved and intentional deviations from standard procedures or processes. These deviations are planned and justified in advance, serving various purposes, such as process improvement, method validation, and temporary process changes. Some examples of planned deviations include: Implementing a temporary manufacturing process change to test and validate potential efficiency improvements. Using an alternative raw material as part of a trial to assess its suitability without affecting product quality. Temporarily adopting an alternative testing method to validate its accuracy and reliability compared to the standard method. Change control and change requests are essential components of managing planned deviations in a controlled and systematic manner. Change request documents are part of the change control process. They provide a formal and structured way to propose and justify the planned deviation, outlining its purpose, scope, and potential impact. The change control process in the pharmaceutical industry ensures that relevant personnel can assess and approve the proposed change, considering its implications on product quality, safety, and regulatory compliance. Implementing planned deviations through these processes helps maintain control, traceability, and well-structured documentation. ✔️Unplanned Deviation:- Unplanned deviations refer to a departure from approved procedures without prior notice or intention. Various factors, such as equipment malfunction, employee error, environmental events, or others, can cause them. Unplanned deviations can significantly impact product quality and safety, and such deviations should be investigated promptly to identify the root cause and prevent them from happening again. Some examples of unplanned deviations include: The sudden breakdown of manufacturing equipment leads to deviations from standard operating conditions and affects product quality. Deviations are caused by unforeseen events like power outages, extreme weather conditions, or natural disasters that disrupt manufacturing. Accidental introduction of foreign materials into the production process, leading to material contamination and deviation from product specifications. Companies employ Corrective and Preventive Action (CAPA) processes to effectively address and resolve unplanned deviations. When an unplanned deviation occurs, the CAPA process is used to implement corrective actions, aiming to mitigate the immediate deviation impact. Afterward, preventive actions are developed to avoid the recurrence of similar deviations in the future. #deviations #pharma #QMS #QAGUIDE #CAPA #QA #QE #QUALITY

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

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.

Non-conformities in V&V: A challenge or an opportunity? Let’s discuss strategies to address them while staying compliant. 🚀 🚨 How do you handle deviations or non-conformities in the Verification and Validation (V&V) process while maintaining compliance? Deviations and non-conformities are inevitable in any complex engineering process, including V&V. But how we address them can make all the difference between a setback and an opportunity for improvement. Here are a few strategies to effectively manage them while ensuring compliance with regulatory standards like FDA 21 CFR Part 820: 1️⃣ Quick Detection and Documentation: The first step is promptly identifying and documenting the deviation. Transparency is key, so include details such as what happened, why it happened, and its impact on the process or product. 2️⃣ Root Cause Analysis: Use proven techniques like the 5 Whys or Fishbone Diagrams to pinpoint the root cause. Understanding the "why" behind the deviation ensures you can address it at its core and prevent recurrence. 3️⃣ Implement Corrective Actions: Develop and execute a Corrective and Preventive Action (CAPA) plan. Ensure actions are realistic, time-bound, and effective in addressing both immediate and systemic issues. 4️⃣ Assess Regulatory Impact: Evaluate how the deviation impacts compliance requirements. If necessary, consult with regulatory experts to determine the appropriate reporting and resolution steps. 5️⃣ Review and Learn: Use deviations as learning opportunities. Regularly review trends in non-conformities to identify areas for process improvement and enhance your V&V framework. 💬 Your Turn: How does your team handle deviations in the V&V process? What strategies or tools have helped you ensure compliance and continuous improvement? Share your insights below! #MedicalDevices #VerificationAndValidation #FDACompliance #QualityEngineering #NonConformities #RiskManagement #RegulatoryAffairs #LeadershipInQA

🔬 Jim Agalloco's 1994 definition of validation continues to underscore the thorough approach necessary in the health and life sciences sector. Even decades later, it remains a cornerstone for industry professionals. 🔍 Beyond meeting standards, this definition emphasizes the integration of validation with routine production and quality control practices. It’s not just about compliance—it's about enhancing operational efficiency and product quality from the ground up. 🔄 By advocating a lifecycle approach, validation ensures that systems and products consistently meet rigorous standards, enhancing both safety and efficacy through all stages—from design and development to operation and maintenance. 👨🔬 From my own experience, aligning these principles with Good Manufacturing Practices (GMP) is crucial for maintaining product integrity and quality. My work in equipment commissioning, validation, and temperature mapping studies reflects a commitment to excellence at every phase of product lifecycle, ensuring compliance and operational superiority. 🌟 How have you implemented these validation principles in your projects? I’d love to hear about your challenges and successes! 🔄 #Validation #GMP #QualityControl #RegulatoryCompliance

A life cycle model is a very underrated expression, it allows manufacturers to proceed in applying lean methodologies that are both more effective and in compliance. 👍

VALIDATION POLICY https://lnkd.in/g5eumXnT The facility shall be validated in accordance with the systems, guidelines and procedures established by organization All new equipments/systems/instruments/processes introduced in the manufacturing unit shall be validated prior to routine use. Validation is required for the following, but not limited to: If new equipment is introduced. In the event of significant alterations or modifications to the processing equipment If the composition of the product, the manufacturing procedure, or the batch size is changed. If requested by regulatory authorities. Validation protocols shall be prepared by the validation coordinator as per the contents listed out for each type of validation protocol as per the Validation master plan Click the link for complete procedure: