Yan Kugel’s Post

🔍✨ 𝐔𝐧𝐯𝐞𝐢𝐥𝐢𝐧𝐠 𝐭𝐡𝐞 𝐓𝐫𝐮𝐞 𝐈𝐦𝐩𝐚𝐜𝐭: 𝐓𝐡𝐞 𝐇𝐢𝐝𝐝𝐞𝐧 𝐂𝐨𝐬𝐭𝐬 𝐨𝐟 𝐈𝐦𝐩𝐫𝐨𝐩𝐞𝐫 𝐑𝐨𝐨𝐭 𝐂𝐚𝐮𝐬𝐞 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐢𝐧 𝐆𝐌𝐏 ✨🔍 💊Root Cause Analysis (RCA) plays a pivotal role within Good Manufacturing Practices (GMP). When RCA is not performed effectively, the repercussions can result in hidden costs that significantly impact both the manufacturing process and product quality. 🌿⚖️ One of the primary hidden costs of improper RCA is the emergence of recurring quality issues. Without identifying and addressing the root cause of problems, issues can persist, leading to a cycle of repeated challenges that consume time and resources without providing lasting solutions. 🏭💊Furthermore, inadequate RCA can contribute to frequent production downtime. When underlying issues remain unresolved, manufacturing processes are frequently disrupted, resulting in decreased productivity, increased maintenance costs, and delays in product delivery that can have financial implications for the company. Image Credit: Pejman Milani 📢 Join us on our upcoming webinar on May 16th, when we will equip you with tools and scenarios to manage sound investigations and utilise the correct tools to achieve an effective root cause analysis. Meet the Speaker 🎙 Kay Flahive, an experienced QP consultant Check the Comments Section below and register today ⬇ #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

🔍✨ 𝐔𝐧𝐯𝐞𝐢𝐥𝐢𝐧𝐠 𝐭𝐡𝐞 𝐓𝐫𝐮𝐞 𝐈𝐦𝐩𝐚𝐜𝐭: 𝐓𝐡𝐞 𝐇𝐢𝐝𝐝𝐞𝐧 𝐂𝐨𝐬𝐭𝐬 𝐨𝐟 𝐈𝐦𝐩𝐫𝐨𝐩𝐞𝐫 𝐑𝐨𝐨𝐭 𝐂𝐚𝐮𝐬𝐞 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐢𝐧 𝐆𝐌𝐏 ✨🔍 💊Root Cause Analysis (RCA) plays a pivotal role within Good Manufacturing Practices (GMP). When RCA is not performed effectively, the repercussions can result in hidden costs that significantly impact both the manufacturing process and product quality. 🌿⚖️ One of the primary hidden costs of improper RCA is the emergence of recurring quality issues. Without identifying and addressing the root cause of problems, issues can persist, leading to a cycle of repeated challenges that consume time and resources without providing lasting solutions. 🏭💊Furthermore, inadequate RCA can contribute to frequent production downtime. When underlying issues remain unresolved, manufacturing processes are frequently disrupted, resulting in decreased productivity, increased maintenance costs, and delays in product delivery that can have financial implications for the company. Image Credit: Pejman Milani 📢 Join us on our upcoming webinar on May 16th, when we will equip you with tools and scenarios to manage sound investigations and utilise the correct tools to achieve an effective root cause analysis. Meet the Speaker 🎙 Kay Flahive, an experienced QP consultant Check the Comments Section below and register today ⬇ #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

𝑻𝒊𝒓𝒆𝒅 𝒐𝒇 𝑹𝒆𝒄𝒂𝒍𝒍𝒔? 𝑰𝒕 𝑫𝒐𝒆𝒔𝒏'𝒕 𝑯𝒂𝒗𝒆 𝒕𝒐 𝑩𝒆 𝑻𝒉𝒊𝒔 𝑾𝒂𝒚! Join MasterControl for a FREE webinar on 𝐃𝐞𝐜𝐞𝐦𝐛𝐞𝐫 𝟏𝟎𝐭𝐡 𝐚𝐭 𝟏:𝟎𝟎 𝐏𝐌 𝐄𝐒𝐓 (𝟏𝟎:𝟎𝟎 𝐀𝐌 𝐏𝐒𝐓, 𝟏𝟏:𝟎𝟎 𝐀𝐌 𝐌𝐒𝐓, 𝟏𝟐:𝟎𝟎 𝐏𝐌 𝐂𝐒𝐓) and discover how a robust Quality Management System (QMS) can help you: 𝐄𝐥𝐢𝐦𝐢𝐧𝐚𝐭𝐞 𝐑𝐞𝐜𝐚𝐥𝐥𝐬: ❌ Learn how to prevent costly and damaging product recalls with a comprehensive QMS solution. 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞 𝐘𝐨𝐮𝐫 𝐏𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬: 🚀 Boost efficiency and save time with automated workflows and centralized document management. 𝐄𝐧𝐬𝐮𝐫𝐞 𝐂𝐨𝐧𝐬𝐢𝐬𝐭𝐞𝐧𝐭 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: ✅ Stay ahead of regulations and ensure quality throughout your entire manufacturing process. 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐧𝐨𝐰 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐥𝐢𝐧𝐤 𝐡𝐞𝐫𝐞 𝐨𝐫 𝐨𝐧 𝐭𝐡𝐞 𝐞𝐯𝐞𝐧𝐭 𝐩𝐚𝐠𝐞: https://bit.ly/49g1RsU 𝐃𝐨𝐧'𝐭 𝐦𝐢𝐬𝐬 𝐨𝐮𝐭! Learn how a MasterControl QMS can be your secret weapon for achieving operational excellence. 𝐁𝐮𝐬𝐲 𝐬𝐜𝐡𝐞𝐝𝐮𝐥𝐞? 𝐍𝐨 𝐩𝐫𝐨𝐛𝐥𝐞𝐦! 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐚𝐧𝐲𝐰𝐚𝐲 𝐚𝐧𝐝 𝐰𝐞'𝐥𝐥 𝐬𝐞𝐧𝐝 𝐲𝐨𝐮 𝐭𝐡𝐞 𝐫𝐞𝐜𝐨𝐫𝐝𝐢𝐧𝐠 𝐭𝐨 𝐰𝐚𝐭𝐜𝐡 𝐚𝐭 𝐲𝐨𝐮𝐫 𝐜𝐨𝐧𝐯𝐞𝐧𝐢𝐞𝐧𝐜𝐞. #MasterControl #LifeSciences #pharmaceutical #medicaldevices #personalizedmedicine #biotechnology #medicalmanufacturing #pharmaceuticalmanufacturing #medicaldevicemanufacturing

Pharma industry is challenging and the one thing you need to do absolutely right is the serialization program. Ensure you get it done from an experienced company. Contact TTI at ✉️ Info@tracktraceit.com / 📞 (310)-228-0564 #TrackTraceIT #Pharma #PharmaIndustry #PharmaManufacturing #Expertise #DigitalTransformation #SupplyChain #Compliance #DSCSA #FDI #TechSolutions #SerializationExperts #PeaceOfMind #Production #SerializationProcess #Technology #Innovation #Ecosystem #IndustryStandards #RegulatoryCompliance #SupplyChainManagement

Empower your Pharma Manufacturing with TrackTraceIT's Serialization expertise. Achieve compliance and efficiency seamlessly, ensuring quality and safety every step. #TrackTraceIT #Pharma #PharmaIndustry #PharmaManufacturing #Expertise #DigitalTransformation #SupplyChain #Compliance #DSCSA #FDI #TechSolutions #SerializationExperts #PeaceOfMind #Production #SerializationProcess #Technology #Innovation #Ecosystem #IndustryStandards #RegulatoryCompliance #SupplyChainManagement

This process outlines the 6 steps necessary to have a robust RCA process. The challenge is doing each step within KPI timelines. It sometimes becomes a balance between getting something out to the client as soon as possible versus doing the necessary deep dive to find the true root cause. In a past life, the first three steps were crushed into 5 working days. Then, the next 2 were given 3 weeks. The last step was allowed to flounder until someone actively chased it. While deadlines focus the mind, I don’t think that crushing the first three crucial steps into such a short amount of time serves the issue in the best way, especially when you must also work on immediate containment actions in parallel. But the further you get from the incident, the fuzzier everyone’s recollection and the harder the jigsaw is to recreate. Finding a balance that works for your organisation is key and unfortunately it’s not easy to find that balance at times.

In the world of pharmaceutical and biotech industries, the preparation and execution of a robust validation protocol are critical for ensuring product quality, consistency, and compliance. One of the key elements that significantly impact the success of this process is the relationship between Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). By focusing on CPPs that directly affect CQAs, we can achieve greater control over the production process, ultimately ensuring that products meet predefined quality standards. Understanding how these process parameters influence quality attributes is not only essential for process optimization but also plays a crucial role in a solid Technical Risk Assessment (TRA). A well-structured TRA that considers CPPs in relation to CQAs allows for: 1- Proactive Risk Identification: Potential risks are identified early in the development phase, enabling teams to take corrective actions before they impact the final product. 2- Enhanced Predictability: Clear visibility into how CPPs influence CQAs enables more predictable outcomes, reducing variability and ensuring consistent product quality. 3- Efficient Validation Protocols: A stable process built on solid risk assessment data leads to smoother and more effective validation protocol development, ensuring compliance and reducing time-to-market. The integration of CPPs into your TRA process is a powerful strategy to ensure the consistency and reliability of your product. By minimizing risk and maximizing control, you are not only safeguarding the product but also optimizing your resources to deliver high-quality results. 💯 #PharmaInnovation #ProcessControl #CriticalQualityAttributes #TechnicalRiskAssessment #ValidationProtocol #QualityAssurance #PharmaceuticalIndustry #ProductDevelopment #Compliance