Eurofins BioPharma Product Testing North America’s Post

Interested in the pending release of PDA - Parenteral Drug Association's Technical Report 22 on Process Simulation for Aseptically Filled Products? Check out this Q&A from some of the committee members who helped developed this critical document. Our top focus was modernization of risk based approaches and alignment with EU Annex 1 but a lot was changed since original release of this document back in 2011. Take a look at some of the changes articulated in our PDA letter article, and as soon as we have a release date - I will share that too! Link here: https://lnkd.in/eDVA7B8k #PDATR22 #ProcessSimulation #ContaminationControl

Stay Informed and Contact Us for Sterilization Guidance and Support 📞 (763) 639-7111 🌐 https://wix.to/AqcCnlx Information provided by the EPA regarding ethylene oxide regulation and emissions control can influence various aspects of the medical device industry, from sterilization practices to regulatory compliance and risk management. Manufacturers and other stakeholders in the medical device industry can use this information to inform their sterilization practices, ensure regulatory compliance, and uphold safety and quality standards. "What EPA Is Doing to Address Ethylene Oxide (EtO) and to Learn More About the Chemical" https://lnkd.in/grnnYDaz "FDA Review of EPA Final Rule, “Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review” " https://lnkd.in/gBWyBudA #EPA #FDA #EthyleneOxide #EtO #Sterilization #Medical Devices #Safety #Quality #Standards #Regulations #Guidance #Rule #April9 #MicroBioConsulting

Between 2011 and 2021, 188 endotoxin-related FDA Form 483s were issued to drug and device manufacturers. The FDA requires that endotoxin testing is performed for API and raw materials, container closure equipment, process intermediates, finished drug product, devices, and manufacturing equipment. Furthermore, the product must be validated to demonstrate that the product and matrix do not interfere with the endotoxin test. The Hyde Analytical Laboratory has introduced routine endotoxin, TOC, and HPLC analysis to help our clients reduce QC testing bottlenecks, making it easy to establish routine testing protocols that are compliant, risk-based, and put the patient first. Get to know our lab and reach out to an expert!: https://lnkd.in/gxG4yGri Michael Lund Nicole Collier Linda Long Keith Bader John Hyde #hydeanalyticallaboratory #endotoxin #qualitycontrol #483 #laboratory #cleaningvalidation #drugsafety

⬇️ Download our latest technical poster: https://okt.to/Gkd5f9 We collaborated with Waters Corporation to develop a reliable UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in drug products, utilizing their mass spectrometry technology alongside LGC reference standards. With increasing regulatory scrutiny from the FDA and EMA, this case study reveals how our method can help ensure your products meet the highest safety standards. #PharmaQuality #Nitrosamines #AnalyticalExcellence #AnalyticalChemistry

💉Creating a control strategy centered around cleanroom behaviors is paramount. Solely relying on retraining won't sufficiently address the widespread issue. Explore this approach grounded in behavioral research: https://lnkd.in/g8Zpxm7U #Pharmaceuticals #CleanroomExcellence #CleanroomManagement #RABS #Aseptic SATISH JOSHI Dr. Ajay Babu Pazhayattil Marzena Ingram Mava Fakoori American Pharmaceutical Review

⬇️ Download our latest technical poster: https://okt.to/LoRAz3 We collaborated with Waters Corporation to develop a reliable UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in drug products, utilising their mass spectrometry technology alongside LGC reference standards. With increasing regulatory scrutiny from the FDA and EMA, this case study reveals how our method can help ensure your products meet the highest safety standards. #PharmaQuality #Nitrosamines #AnalyticalExcellence #AnalyticalChemistry

⬇️ Download our latest technical poster: https://okt.to/k5xFXm We collaborated with Waters Corporation to develop a reliable UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in drug products, utilising their mass spectrometry technology alongside LGC reference standards. With increasing regulatory scrutiny from the FDA and EMA, this case study reveals how our method can help ensure your products meet the highest safety standards. #PharmaQuality #Nitrosamines #AnalyticalExcellence #AnalyticalChemistry

⬇️ Download our latest technical poster: https://okt.to/qYuFyb We collaborated with Waters Corporation to develop a reliable UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in drug products, utilising their mass spectrometry technology alongside LGC reference standards. With increasing regulatory scrutiny from the FDA and EMA, this case study reveals how our method can help ensure your products meet the highest safety standards. #PharmaQuality #Nitrosamines #AnalyticalExcellence #AnalyticalChemistry

⬇️ Download our latest technical poster: https://okt.to/X0galT We collaborated with Waters Corporation to develop a reliable UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in drug products, utilizing their mass spectrometry technology alongside LGC reference standards. With increasing regulatory scrutiny from the FDA and EMA, this case study reveals how our method can help ensure your products meet the highest safety standards. #PharmaQuality #Nitrosamines #AnalyticalExcellence #AnalyticalChemistry

The market for complex generics in oral solid dosage (OSD) forms is expanding swiftly, yet it brings distinct challenges. 💊 Tackling complicated formulations and adhering to stringent regulatory requirements demands that drug sponsors secure a partnership with an adept CDMO to surmount these obstacles. Our most recent blog delves deeper into these issues and offers perspectives on how choosing the appropriate CDMO partner can be crucial for project triumph. 🗝️ Discover more by clicking below. 👇 https://gag.gl/eDHMce #OSD #ComplexGenerics #CDMO #Alcami