Chirag Patel

Your QC lab’s resources are limited, and the expected output is higher than ever. Failed chromatographic runs cost you valuable time and effort. The Alliance iS HPLC System reduces errors so you can have peace of mind that your samples will run correctly. Learn more at https://bit.ly/3VvAV2Z

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"🚨 Quality Over Correction: The FDA's Wake-Up Call in 2024 🚨 In 2024 alone, the FDA has issued a staggering 15 cease decrees, a testament to the urgent need for proactive quality assurance (QA). As professionals, especially from the east coast to all across the US, we're witnessing the pivotal role QA plays - not just as a fix-it tool but as a prevention powerhouse. The decrees are clear indicators that it's time to shift our focus. 🛑✋ 1) Integrating QA from the get-go is critical. Implementing robust quality controls at each production stage can be the difference between a product's success and a costly recall. Real-time monitoring and risk assessments are no longer optional; they're the lynchpins of trust in our industry. 2) Leveraging QA as a continual process, rather than a final checkpoint, transforms our mindset. It's about embedding a culture of excellence within teams. Embrace QA as the heart of operations, not the ambulance at the bottom of the cliff. 3) The statistics don't just urge, they scream for a change. With the right QA practices, not only do we safeguard consumer health, but we also bolster industry credibility and our own bottom lines. It's a win-win that calls for immediate action and commitment. Leaders, it's time we ask ourselves—is our QA proactive or merely reactive? 🤔 Join the movement towards a safer, more reliable future. Share your thoughts below. ⬇️ #QualityAssurance #FDACompliance #ProactiveChange"

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🌟 Exciting News from Diasorin! 🌟 DiaSorin has just received FDA 510(k) clearance for its updated NxTag Respiratory Pathogen Panel v2, now including SARS-CoV-2 detection! 🎉 This advanced multiplex PCR assay can detect 19 viral and 2 bacterial targets, offering comprehensive insights into respiratory infections. With improvements in test accuracy and ease of use, this panel ensures top-notch performance on the high-throughput Luminex Magpix instrument, which can process 96 specimens per run. 💪🔬 Thanks to support from the U.S. Department of Health and Human Services (HHS) and Human Services' BARDA, DiaSorin has enhanced its capabilities to meet the ongoing challenges of respiratory pathogens. 🤝 Key Highlights: ✅ Includes SARS-CoV-2 along with other coronaviruses, flu A/B, RSV, and more. ✅ Enhanced accuracy and user-friendly design. ✅ Ready-to-use lyophilized reagent wells for convenience. This advancement represents a significant step forward in diagnostic precision and support for public health. 🌍💙 #DiaSorin #FDAApproval #PCR #Diagnostics #SARSCoV2 #HealthcareInnovation #RespiratoryHealth #PublicHealth #BARDA #MedicalResearch #LaboratoryScience #HighThroughputTesting

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🌼 Spring into new beginnings with our Regulatory Affairs opportunities blooming in the Northeast!   Whether you're a Regulatory Affairs professional or seeking talent, connect with us today and let's grow together! 🌱 #SpringIntoOpportunities #Partnership #RegulatoryAffairs

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𝐄𝐱𝐩𝐥𝐨𝐫𝐞 𝐤𝐞𝐲 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐛𝐞𝐡𝐢𝐧𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 (𝐐𝐂) 𝐬𝐚𝐦𝐩𝐥𝐞𝐬 𝐢𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐛𝐢𝐨𝐚𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐫𝐞𝐩𝐨𝐫𝐭𝐬 𝐢𝐧 𝐨𝐮𝐫 𝐥𝐚𝐭𝐞𝐬𝐭 𝐛𝐥𝐨𝐠! 📰 Dive into the nuances of their presentation, accuracy, and precision. 👉 https://lnkd.in/g8jNF5Hc Celegence unites a team of seasoned #medicalwriters and #regulatory consultants, specializing in the intricate world of regulated bioanalysis. Our diverse expertise ensures meticulous attention to detail in every client program, with a focus on the critical role of QC samples ensuring accuracy, precision, and compliance. 📧 Are you prepared to enhance your bioanalytical processes? Let's connect: https://lnkd.in/g9bGxh6U #clinicaltrials #biotech #bioanalysis #clinicalresearch #CRO #drugs #bioanalyticalexpertise #drugdevelopment #drugdiscovery #pharma #regulatedbioanalysis #lifesciences #regulatorycompliance

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Quality Assurance in 200 Words or Less SOPs Set Boundaries SOPs should be written to clearly define the boundaries under which an activity is to be performed. We all know there are going to be the exceptions. Don’t fall in the trap of trying to cover the exceptions in the SOP directions. Write the SOP to cover the expected actions in such a way that Quality Assurance can audit for compliance. We live in a world of deviations – use deviations to document the exceptions. A common example is the requirement for reading and documenting new or revised controlled documents where the SOP is written that the individual must read and document by the effective date, but if they don’t, they just must read it and document before they use the SOP. This is an impossible situation for Quality Assurance to audit for compliance. It also sets a poor expectation for how individuals understand the importance of staying up to date in their training. If a person is sick, or on vacation/leave – when they return just have them document their training and issue a deviation – it is as simple as that.

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Get ready for Episode 7 of the GxPodcast! 🎙️ This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma. Tune in to hear us discuss quality culture and excellence in life sciences. We look at cell and gene manufacturing, the connection between innovation and purpose, and the importance of data management in our industry. Tune in to the full episode here: 🔗 https://lnkd.in/exW4jkBB #GXPodcast #iPharmGxP

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🚀 Exciting collaboration announcement! Kincell Bio and Imugene Limited have unveiled a strategic manufacturing and process development partnership, featuring the sale of Imugene's North Carolina CGMP manufacturing facility and the transfer of process and analytical development activities to Kincell. 💼 The strategic alliance includes a manufacturing supply agreement wherein Kincell will manufacture Imugene's Azer-cel to support ongoing clinical trials. Additionally, Kincell will take over the process and analytical development of Azer-cel to optimize its readiness for commercial production. 🏭 The acquisition of Imugene's 32,800-square-foot CGMP-compliant facility marks a significant milestone for Kincell, enabling them to evolve site capabilities and manufacture a broad portfolio of autologous and allogeneic products. The facility's location in Research Triangle Park (RTP) will facilitate access to talent in the fast-growing biotech hub. 🌍 This partnership underscores the commitment of both Imugene and Kincell to advancing immunocellular therapies and addressing significant unmet medical needs for patients worldwide. 🌐 #PharmaceuticalIndustry #Partnership #TherapeuticInnovation #ImmunocellularTherapies #Biotech #CDMO #Collaboration

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Expanded Oral Dosage Formulation Capabilities…

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Interesting inphographic highlighting the technologies used by 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗗𝗠𝗢𝘀 who develop and manufacture 𝗙𝗶𝗻𝗶𝘀𝗵𝗲𝗱 𝗗𝗼𝘀𝗮𝗴𝗲 𝗙𝗼𝗿𝗺𝘀 of small molecules. 𝗧𝗢𝗣 𝟯! 🥇 Tablets (218 companies) 🥈 Capsules (192 companies) 🥉 Liquids (163 companies) 𝗞𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀: 🧪 Increasing availability of CDMOs offering sterile glass vials over glass ampoules. 💉 Growing trend of CDMOs providing pre-filled syringes. 💊 Rise in CDMOs offering high-potency solids for Oral Solid Dosage forms. 🗜 Some CDMOs offer less common technologies such as blow fill seal amps, sterile bags, and cartridges. Full article by PharmaSource in comments... #CDMO #SmallMolecules #Pharma

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🔬 Big News Alert! 🔬 🌟 FDA, EPA, and USDA join forces to streamline regulation for biotech products! 🌟 Interesting times ahead for the biotech industry as these agencies collaborate to simplify pathways to market while maintaining rigorous safety standards. How do you think this will shape the future of biotech? 💥 #Biotech #Regulation #Innovation #FDA #EPA #USDA

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Ready to be a leader in multi-attribute methods (MAM) workflows? Check out the Waters MAM Resource Center for guidance. Resources such as application notes, on-demand webinars, & much more now at your fingertips in one simple hub. Find out more: https://bit.ly/48mlugQ #MAM #Biopharmaceutical

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