Eurofins BioPharma Product Testing Italy’s Post

Attended an eye-opening webinar on "Nitrosamine Impurities" by Bhaskar Napte ~ Pharma Coach.Nov, 17 2024 The session provided an in-depth understanding of the risks associated with nitrosamines in pharmaceuticals, their chemistry, formation mechanisms, nitrosating agents and mitigation strategies. A valuable opportunity to learn about industry best practices for ensuring drug safety and regulatory compliance. Key Learnings 1. History of Nitrosamine: Origins and recognition of nitrosamine impurities in pharmaceuticals. 2. Understanding Nitrosamine and NDSRI: Differentiating nitrosamines and nitrosamine drug substance-related impurities (NDSRIs). 3. Formation Mechanisms: How nitrosamines and NDSRIs are formed during manufacturing processes. 4. Risk Assessment: Importance of creating comprehensive risk assessment reports. 5. Prevention Strategies: Techniques to prevent nitrosamine contamination. 6. Acceptable Limits: Defining and adhering to acceptable regulatory thresholds. #NitrosamineImpurities #DrugSafety #Pharmaceuticals #RiskAssessment #HealthcareInnovation

In API manufacturing, contamination risks are everywhere. What are the key threats that could compromise an entire batch? Swipe through to learn more and see how Distran can help protect your batch integrity. ⤵ #Chemistry #Pharmaceuticals #pharma #safety

Microbial Control Considerations During Product Development: ·        A formal risk assessment program that identifies risk modalities and assigns critical control points for manufacture of non-sterile product is useful. ·        Points to be considered for pharmaceutical microbiologists when they assess the potential risk associated with Nonsterile drug product manufacture are listed below: 1.     Synthesis, isolation, and final purification of the drug substance 2.     Microbiological attributes of the active substance 3.     Microbiological attributes of excipients and intermediates 4.     Antimicrobial properties of the material e.g. water activities or other 5.     Manufacturing process 6.     Delivery system 7.     Packaging 8.     Route of administration 9.     Population to which product is delivered e.g. neonates, immune-compromised patients. #microbiologist

𝘛𝘩𝘪𝘴 𝘷𝘪𝘵𝘢𝘭 𝘪𝘮𝘱𝘶𝘳𝘪𝘵𝘺 𝘰𝘧 𝑨𝒛𝒂𝒄𝒊𝒕𝒊𝒅𝒊𝒏𝒆 𝘪𝘯𝘷𝘰𝘭𝘷𝘦𝘴 𝘴𝘰𝘮𝘦 𝘤𝘳𝘪𝘵𝘪𝘤𝘢𝘭 𝘴𝘵𝘦𝘱𝘴. 𝘛𝘩𝘪𝘴 𝘮𝘰𝘭𝘦𝘤𝘶𝘭𝘦 𝘩𝘢𝘴 𝘣𝘦𝘦𝘯 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘦𝘥 𝘪𝘯 𝘔𝘨 𝘵𝘰 𝘎 𝘴𝘤𝘢𝘭𝘦 𝘸𝘪𝘵𝘩 𝘮𝘰𝘳𝘦 𝘵𝘩𝘢𝘯 95% 𝒑𝒖𝒓𝒊𝒕𝒚 𝘢𝘯𝘥 𝘪𝘴 𝘣𝘦𝘪𝘯𝘨 𝘴𝘦𝘳𝘷𝘪𝘤𝘦𝘥 𝘵𝘰 𝘦𝘴𝘵𝘦𝘦𝘮𝘦𝘥 𝘗𝘩𝘢𝘳𝘮𝘢 𝘤𝘶𝘴𝘵𝘰𝘮𝘦𝘳𝘴 𝘪𝘯 𝘥𝘰𝘮𝘦𝘴𝘵𝘪𝘤 𝘮𝘢𝘳𝘬𝘦𝘵𝘴 𝘢𝘴 𝘢 𝘞𝘰𝘳𝘬𝘪𝘯𝘨 𝘚𝘵𝘢𝘯𝘥𝘢𝘳𝘥 𝘸𝘪𝘵𝘩 𝘢𝘭𝘭 𝘤𝘩𝘢𝘳𝘢𝘤𝘵𝘦𝘳𝘪𝘻𝘢𝘵𝘪𝘰𝘯 𝘥𝘢𝘵𝘢 𝘴𝘶𝘤𝘩 𝘢𝘴 1𝘏 𝘕𝘔𝘙, 𝘔𝘢𝘴𝘴, 𝘐𝘙, 𝘏𝘗𝘓𝘊 𝘗𝘶𝘳𝘪𝘵𝘺 𝘢𝘯𝘥 𝘛𝘎𝘈 𝘦𝘵𝘤. Contact us today for more Product Information! Contact us:📱+91-9327839503 Kindly share your enquiries on 📧: sales1@spectrasynth.com 🌐Website: https://lnkd.in/gvB44j-q Kindly follow us on: LinkedIn: https://lnkd.in/gBRZjTy6 #Azacitidine #Azacitidinrimpurities #Antibiotics #Impurities #CRO #Pharmaceuticals #DrugDevelopment #QualityControl #AnalyticalChemistry #RegulatoryCompliance #GMP #FDA #DrugSafety #ClinicalTrials #Bioanalysis #ChemicalAnalysis #ImpurityTesting #ContractResearchOrganization #PharmaIndustry #DrugManufacturing #DrugFormulation #Pharmacovigilance #DrugDiscovery #ChemicalSynthesis #ImpurityIdentification #ProcessValidation #QualityAssurance #DrugTesting #DrugRegulation #PharmaceuticalStandards #ImpurityCharacterization #DrugQuality #ChemicalPurity #CROServices #Isolation #Purification #characterization

US FDA recently published a revised guideline on Nitrosamine Impurities. The recommendations made in this guidance apply to the following: • All chemically synthesized APIs • Drug products containing chemically synthesized APIs or fragments (including biological products containing synthesized fragments) • Drug products at risk due to other factors • Semisynthetic and fermentation products that are at risk due to their structures, similar to chemically synthesized APIs #fda #guidance #nitrosamines #usfda #september2024 #pharmaceuticals #impurities #learning #developement #inpharmedia #guidelines #analytical #methoddevelopment

#Toxicological risk assessment of extractable and leachable #impurities At Netpharmalab we recognize the duality of #pharmaceutical and #biopharmaceutical containers and delivery systems: on one hand, they protect against environmental contamination, on the other, they can be potential sources of contamination. Our controlled extraction studies are designed to identify and quantify #extractable impurities that could migrate from #polymeric materials to pharmaceutical products under extreme conditions. 👉 https://lnkd.in/eGFtrTdR We have a team of experienced professionals and highly qualified #toxicologists. We are dedicated to conducting accurate and detailed evaluations, ensuring #safety and #compliance with the highest #qualitystandards 👨🔬 #leachableimpurities #extractableimpurities #pharma #pharmaceuticalindustry #medications #pharmasector

🚀𝐆𝐮𝐞𝐬𝐭 𝐁𝐥𝐨𝐠 𝐀𝐥𝐞𝐫𝐭 🔔      🌐 A new expert article is now live on our website.      💊 Learn about the recent analysis where 103 different genera of microorganisms were identified, with Pseudomonas spp and Bacillus spp standing out as the top isolates causing various impacts. ✍ The author is Beatriz Rodriguez Vera, the Director and founder of BMRV Consultoria. 💡Know about the prevalent microorganisms Pseudomonas spp and Bacillus spp in the manufacturing industry. Understand their characteristics, occurrences, challenges, and relevance in product contamination. Stay informed on the measures to prevent microbial contamination and ensure product quality control. 𝐂𝐡𝐞𝐜𝐤 𝐨𝐮𝐭 𝐭𝐡𝐞 𝐥𝐢𝐧𝐤 𝐢𝐧 𝐭𝐡𝐞 𝐂𝐨𝐦𝐦𝐞𝐧𝐭𝐬 𝐒𝐞𝐜𝐭𝐢𝐨𝐧 𝐭𝐨 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐀𝐫𝐭𝐢𝐜𝐥𝐞 ⬇ 📢Keep following me and Qualistery for more GMP content and webinars #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

🚨 Attention pharmaceutical professionals! 🚨 Don't miss the Genotoxic Impurities Summit: Nitrosamines & Beyond, where experts will tackle the latest challenges in detecting, assessing, and controlling genotoxic impurities—especially nitrosamines. With evolving regulations and heightened safety standards, this summit is a must-attend for anyone involved in drug development, regulatory affairs, and quality assurance. Join us for key insights, practical strategies, and networking opportunities to stay ahead in the fight against impurities that pose a risk to patient safety. 🔗 https://lnkd.in/dAD9bB7W #Genotoxic #Nitrosamines #Pharma #Regulatory #Pharmaceutical #Innovation #NDSRI #Mutagenic #Impurities #Drug #Quality #Safety #Risk #Beyond #Analytical #Science #Toxicology #Chemical #Biotech

🚨 Attention pharmaceutical professionals! 🚨 Don't miss the Genotoxic Impurities Summit: Nitrosamines & Beyond, where experts will tackle the latest challenges in detecting, assessing, and controlling genotoxic impurities—especially nitrosamines. With evolving regulations and heightened safety standards, this summit is a must-attend for anyone involved in drug development, regulatory affairs, and quality assurance. Join us for key insights, practical strategies, and networking opportunities to stay ahead in the fight against impurities that pose a risk to patient safety. 🔗 https://lnkd.in/gQRnEBeX #Genotoxic #Nitrosamines #Pharma #Regulatory #Pharmaceutical #Innovation #NDSRI #Mutagenic #Impurities #Drug #Quality #Safety #Risk #Beyond #Analytical #Science #Toxicology #Chemical #Biotech

🌟 Exciting News for the Pharma Community! 🌟 We are thrilled to announce our #latest #newsletter: #Fujicalin®: Your Partner in #Mitigating #Nitrosamine #Impurities in Drug Products." 📄 ✨In this edition, we deep dive into how #Fujicalin® can help you navigate the challenges of #nitrosamines in #pharmaceuticals. With our robust nitrosamine risk assessments and #rigorous #testing #protocols, Fujicalin® stands out as a #lowrisk #excipient that ensures #regulatory #compliance and enhances #product #safety🛡️💊 🔍 What’s Inside? 💫 Comprehensive nitrosamine risk assessments tailored for Fujicalin® 💫Insights on regulatory compliance and the latest industry standards 💫Expert guidance to optimize Fujicalin® use in sensitive formulations With levels of #nitrites detected at only 0.004ppm in water used for Fujicalin®'s manufacturing process, our commitment to quality is evident! Let's prioritize safety together. 🙌📥 Don't miss out!  Check out the newsletter for valuable insights and strategies to enhance your formulations. Megha Marwah, Ph.D (Tech.) Jeffrey Langa Mark Plunkett Pankaj Negi #Fujicalin #FujiChemicalIndustries #Excipients #Nitrosamine #Pharmaceuticals #DrugSafety #RegulatoryCompliance #PharmaInnovation #PatientSafety #QualityAssurance Feel free to share this with your network! Let's work together to create safer pharmaceutical products! 🤝💙