Q1 Scientific’s Post

Vital regulation updates for #pharmaceuticalindustry leaders! 🌡️   Dive into an insightful expert interview on the mandatory transition from the Italian Bollino security label for pharmaceutical products system (Bollino) to the European Union's Falsified Medicines Directive (EU-FMD) regulation by 2025. Top supply chain traceability and product serialization experts Ankit Singla and Uwe Rauschenberg from Engineering Industries eXcellence shed light on this critical shift in this critical industry for businesses, products and patients alike.   In this video, discover: ✅ What Bollino and EU-FMD are ✅ Key changes for Italian manufacturers ✅ Advantages of adopting EU-FMD ✅ The importance of GS1 standards ✅ How to ease your transition   Engineering Industries eXcellence is here to guide you through the transition process and transform the way you approach compliance and product tracking. Together, we can elevate pharmaceutical safety and efficiency.   👉 Watch the full video here: https://lnkd.in/eddND6uK   #pharma #digitaltransformation #supplychainmanagement European Union GS1 Engineering Ingegneria Informatica Spa Engineering North America Engineering Brasil Giada Necci Sophie Molle Ettore Soldi Fabio Sala Sandro Buso Stefan Hockenberger Nishant Gupta Marc Blekkink Dieter Laevers Fabio Raffo Enrico Fossati

Announcing the results of our headline poll, Sterilisation vs Sterilization 🦠. We were amazed to have so many pharmaceutical manufacturing professionals from all over the globe take part in our survey. We never imagined that it would result in a 50-50 split. There seems to be passionate people on both sides, and we have learned multiple interesting facts that corroborate one position over another. Participants geographical location influenced voting, with most of Europe (and one of Australia) voting for 's' and the rest of the world voting for 'z'. For us, a business mainly serving the European market, it makes sense to continue using 's' in our communications, given that over 85% of European participants voted this way. However, from the analysis of guidance documents such as Annex 1 and HTM-2010, it is clear that there is a lack of consistency in published guidelines. As quality-focused people, we must reflect on why this is... #Annex1 #HTM2010 European Commission NHS

Are you interested in patient-centric differentiation through the USFDA 505(b)(2) pathway? Nanoform’s VP Strategic Insight, Jamie Unwin, discusses the commercial opportunities created by the 505(b)(2) regulatory pathway for drug approvals in our whitepaper. Discover how 505(b)(2) brands can compete successfully here: https://lnkd.in/eUeRD2we

Keeping you informed on upcoming industry news! Check out this webinar happening next month with the FDA and the CDER. Scroll for more info ... Topics covered will be: ▶ FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generics/Hybrid Products ▶ Generic Drug Cluster ▶ International Collaboration Among Regulatory Agencies Info & registration link 👉 https://lnkd.in/gTWNUXcX #QRxPartners #QRxInforms #fda #cder #smallbusiness #fdacompliance #genericdrugs #webinar #ogc #mlv #regulatory

"Thrilled to have attended the #OneDaySymposium on #GMPCompliances Opportunities: On Export and Import’s Regulators' View at #JSSCollegeofPharmacy, Mysuru, on #April6th2024. A comprehensive exploration of crucial industry standards and regulatory perspectives, fostering invaluable insights for navigating global markets. Grateful for the opportunity to enhance my understanding of regulatory frameworks and trade dynamics in the pharmaceutical sector." #Importexport #GMPcompliance #Regulatorydevelopment

We're proud to announce that a global top-3 auditor has externally reviewed us and consistently revealed a temperature excursion rate of less than 0.05%. This signifies an exceptionally high level of precision and reliability in maintaining required temperatures throughout the entire pharmaceutical supply chain. It sets a new standard in the pharmaceutical industry, with a typical rate of between 1-5%. At SkyCell, our journey towards excellence is not a destination but a continuous pursuit. As our company grows and our operations extend, we steadfastly uphold our unwavering quality standards, ensuring they not only endure but also evolve in tandem with our progress. Curious to learn more about our achievement? Click the link below! 👇 https://lnkd.in/ebXVCEAJ #quality #pharmaceuticalindustry #supplychain #hybridcontainer #supplychainmanagement Source: https://lnkd.in/e94kWkA

Exploring the evolution of regulations! The 21 CFR timeline vividly depicts the journey towards safer, more effective products. From the early days of basic standards to today's sophisticated regulatory landscape, each milestone reflects a commitment to consumer safety and innovation. Understanding this timeline is crucial for anyone involved in the pharmaceutical, medical device, or food industries. Stay updated, stay compliant, and ensure the safety and efficacy of products hitting the market! Connect with our experts - www.biotech.com/contact-us #21cfrpart11 #RegulatoryEvolution #safetyfirst #innovationjourney #RegulatoryJourney #compliancematters #FDA #healthcareevolution #pscbiotech

Exploring the evolution of regulations! The 21 CFR timeline vividly depicts the journey towards safer, more effective products. From the early days of basic standards to today's sophisticated regulatory landscape, each milestone reflects a commitment to consumer safety and innovation. Understanding this timeline is crucial for anyone involved in the pharmaceutical, medical device, or food industries. Stay updated, stay compliant, and ensure the safety and efficacy of products hitting the market! Connect with our experts - www.biotech.com/contact-us #21cfrpart11 #RegulatoryEvolution #safetyfirst #innovationjourney #RegulatoryJourney #compliancematters #FDA #healthcareevolution #pscbiotech

Do you know - Why are so many Cleanroom classes existed? There are total of 9 cleanroom class under ISO 14644-1 standards, whereas FED STD 209E register 6 cleanroom class in maximum and EU GMP standard choose to classified with 4 cleanroom classes. Why would the need to have so many different standards for cleanroom ? Well, in general, it was started for all different reason. Cleanroom classification set by ISO (International Organization for Standardization) is from an independent, NGO dedicated to provide world standards in a variety of industries. Should the companies required USA certification - Federal Standard 209 which is established in 1963 by IEST would be the choice to go. In another hand, pharmaceutical industries would prefer to use EU GMP as their choice. Though the very first EU GMP guidelines were published on the 3rd May, 1989, But, the historical event of drug production can be traced back as early as 1937. Do let me know - which standards that your company is adhering to in your company currently ? #pharmacy #pharmacist #healthcare #research #hospital #biopharma #pharmasales #pharma #pharmaceuticalindustry #healthcaresupplier #medicalsupplier #pharmasales #ammi #mida #miti #medtech #sustainability #carbonreduction #carbonfootprint #supplychain #biodegradable #BiodegradableSupplies #lifesciences #laboratory #LaboratorySupplies #cleanroom #gmp #asepticprocessing #CleanroomSupplies #oilandgas #oilgas #oilandgasindustry

Are you preparing for upcoming inspections? Don't miss out on the invaluable insights and knowledge-sharing opportunities at the #Annex 1 event hosted by Cencora PharmaLex and NIBRT National Institute for Bioprocessing Research and Training! Taking place on May 9th, 2024, at NIBRT, this event will provide you with the latest updates and best practices regarding #Annex 1 compliance. Expert-led sessions on #Annex 1 compliance and interpretation, practical insights and strategies to streamline your inspection processes, networking opportunities with industry peers and regulatory experts, and Q&A sessions to address your specific queries and concerns are just some of the benefits you can expect. Secure your place today and be a part of this unique opportunity to stay up-to-date with the latest regulatory standards in the pharmaceutical industry. Please note places are limited to this event, so don't wait too long to register. View the agenda and register on Eventbrite - to navigate the road to a successful inspection. https://lnkd.in/dHx7ECJR #Annex1 #PharmaceuticalIndustry #Compliance #ProfessionalDevelopment #RegulatoryStandards #Inspections