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🔬 Why Characterize Subvisible Particles? 🛡️ Patient Safety: Ensuring the absence of harmful particles is crucial to safeguarding patient health. 📜 Regulatory Compliance: Agencies like the FDA and EMA mandate strict testing for subvisible particles to meet quality and safety standards. 🏭 Product Quality: Analyzing particle sources and formation mechanisms leads to improved manufacturing processes and higher product quality. ⚠️ Risk Mitigation: Proactively identifying and mitigating particle risks can prevent costly recalls and protect your brand's reputation. Characterizing subvisible particles isn't just about meeting regulations - it's about delivering safer, higher-quality products. ✅ #SubvisibleParticles #CoriolisPharma #DrugDevelopment #Pharma #Biotechnology #RiskMitigation #PharmaceuticalManufacturing #ProductSafety #FDA #EMA #QualityControl #Biopharma #GMP #PharmaInnovation

The cost of the excipient will change... The cost of API will change... The cost of drugs will change... Policies will change... Regulations will change... But the Cost of life will never change... Do you agree with me? www.drrupaliparanjape.com #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #cgmp, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityculture, #quality, #manufacturing, #ceomindset, #ceoinsights, #traininganddevelopment ;  #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape

"As a professional in Quality Assurance, embrace the profound impact of your work. Every test, every validation, and every standard you uphold is a step towards a healthier world. Remember the words of Albert Einstein, 'Only a life lived for others is a life worthwhile.' Your dedication to ensuring the safety and efficacy of medications is a testament to your commitment to humanity, reflecting a life of purpose and positive influence." #Pharma #Pharmaceuticals #Biotech #Biotechnology #MedicalDevices #MedTech #Healthcare #HealthTech #LifeSciences #ClinicalResearch #DrugDevelopment #PharmaIndustry #MedDevice #QA #QualityAssurance #QualityControl #QC #RegulatoryAffair #RegulatoryCompliance #FDA #CECompliance #GMP #ISO13485 #Compliance #PatientSafety #DrugSafety

Stay Ahead of Regulatory Changes – Insights That’s the topic for inaugural keynote session at 6th Annual Pharma Packaging, Labelling, Serialization, Track & Trace and Supply Chain 2024, 24th July 2024, by Virtue Insight Some points we may discuss from - Packaging & labelling - How the pharma industry is keeping up with changing regulations and compliance? Updates - Latest regulations in Packaging and Labelling, Track & Trace Streamlining compliance processes with best possible regulatory practices The near future such as Drug Supply Chain Security Act (DSCSA). Weighing the advantages and regulatory guidelines for digital and e-labelling vs paper labels Gearing yourself up for upcoming regulations to stay competitive and relevant Where are we heading and what’s the way forward? Look forward to listen to the insights from experts Dr. Satya Babu Loganathan S Lokesh Patel Ram Balani SRIDHAR REDDY BADDURI #VIpplst #TrackTrace #Traceability #Anticounterfeiting #smartpackaging #packaginginnovation #pharmalabelling #artwork #pharmalabels #scm #anticounterfeit #barcode #Counterfeit #Healthcare #medicines #Drugregulatory #Pharmaceuticals #clinicaltrials #Qualitycontrol #RegulatoryAffairs #pharmanews #regulatory #pharmaceuticalindustry #biotec Fen Castro #packagingaroundtheworld #wpoaroundtheworld

Unlock cleaner operations with the SSPM Scrubber Machine! By choosing our machine it aligns with legal standards. So you are not only safeguarding your business but also playing a vital role in promoting environmental sustainability. . . [Scrubber Machine, Environmental Compliance, Sustainable Operations, Industrial Cleaning Solutions, SSPM] #scrubbermachine #pharmaceutical #pharmacy #pharma #medicine #healthcare #india #pharmaindustry #SSPM #ahmedabad #SSPMSystemsEngineers #drygranulation #wetgranulation #pharmaceuticalindustry

In this video we will get to know the process of development of pharmaceutical regulations and some tragic events that lead to development of GMP. #pharmaceuticalindustry #qualityassurance #qa #interview #qualitymanagementsystem #naukri #theindianpharmacist #pharmaceuticalindustry : #Development of regulations #processvalidation #pharmacy #pharmaindustry #pharmaceuticalindustry #Theindianpharmacist #india #pharmacian #pharmacy #pharmaindustry #pharmacists #QA #QMS #Quality_Assurance #Quality_Management_System #Pharmaceutical #industry #pharmaceuticalindustry #pharmacian #viral #popular https://lnkd.in/gKnrQGwf

My latest blog with my good friends at @pharmacyu. Check it out! Registration is required to view the article, but it is free! There is a world of difference between compliance and adherence....

Been thinking a lot about #proactive vs reaction. Pharma is still reacting. Joel Russo is calling for still more cops on the beat. Is that the solution? It sounds logical. Katherine Eban is calling us out on data integrity and counterfeit drugs which are both plagues of the kind Joel is so rightly upset about. Ever notice that #provocative contains the word (well letters) of #proactive? This post is intended to be #provocative. Regulator and industry have failed. The “Pharmaceutical”Quality System envisaged in 2008 when ICH Q10 was finalized just slapped some more layers on the GMP - the addition of CAPA muddied the waters rather than clarifying because now we just do “CAPAs” and obviously write how effective these (re)actions are because that’s what the regulator wants to see. What will it take to change the model? Does anyone really believe FDA’s QMM will do it? When and how can we move to a new and effective QMS which #proactively puts effective #preventive measures in place to ensure an uninterrupted supply of quality medicines? Want to join a think tank? email me at karen@pcipharma.com and let’s get our heads around this. Comments, replies, thoughts here - welcome. Or shall we just keep plodding along…

🔍 Regulatory compliance in biopharma is no easy task. The complexities of navigating ever-evolving regulations can seem overwhelming, but they are essential to ensure patient safety and maintaining high-quality standards. For companies like #mAbxience, the challenge goes beyond mere compliance—it’s about turning these complexities into opportunities for growth. 💊🌍 In our latest blog, we dive into the intricate relationship between biopharma manufacturing and regulations, exploring how compliance isn't just a challenge but a strategic advantage. Want to learn how we navigate local and global regulatory requirements to facilitate access to affordable medicines? Click here to read more! https://lnkd.in/d9hh3X6Z #Biopharma #Regulations #Compliance #Biosimilars #CDMO

Debunking Pharma Myths: Revalidation Simplified ✅ Think once a process is validated, it’s set in stone? Myth busted! 💡 Revalidation is a must after significant changes or as per regulatory guidelines. It's not just a box-ticking exercise—it's about ensuring quality, safety, and compliance in pharma manufacturing. 🌟 Fact: Revalidation keeps your operations robust, adaptive, and aligned with industry standards. #PharmaIndustry #Revalidation #ManufacturingExcellence #ComplianceMatters #PharmaInnovation #QualityFirst #EngineeringForPharma #RegulatoryGuidelines #PharmaProjectManagement