Amalia Technologies

Join us to discover how adopting CSV can elevate your organization to the next level. In the pharmaceutical industry, meeting regulatory standards is more than compliance—it's a pathway to business excellence. By implementing Computerized System Validation (CSV), you not only ensure the integrity and safety of your products but also enhance operational efficiency, mitigate risks, and drive long-term cost savings. ✅ Like ✅ Repost ✅ Comment 👉 Follow us for more insights in the Life Sciences industry! #LifeSciences #CSV #Compliance #Regulations #QualityControl #RegulatoryCompliance #Efficiency #CostSavings #PharmaTech #BusinessGrowth #AmaliaTech #AmaliaTechnologies   Amalia Technologies Life Sciences, Simplified

Greetings from our dynamic summer locations! ☀️ This season, the Amalia Technologies team is drawing inspiration from all corners of the globe. Our summer setups, whether by the beach, in the mountains, or in the heart of the city, are sparking creativity and fresh ideas. What's the most interesting place you’ve found yourself this summer? Drop your stories in the comments! 🚀 Wishing you all beautiful summer moments! #AmaliaTech #RemoteLife #SummerVibes #TeamAmalia #ExploreAndCreate

Bruno Maciel is joining our team as a Junior TraceLink Administrator! Bruno will be supporting us with TraceLink Subject Matter Expert (SME) tasks. He has a strong background in Computer Science and brings valuable experience as a Cloud Support Engineer and Information Technology Analyst. Welcome aboard, Bruno! 🎉 #amaliatech #teamwork #CSV #quality #lifesciences #serialization

Join us as we break down global regulations and guidelines for Computerized Systems Validation (CSV) in the pharmaceutical industry. This carousel covers standards from major regulatory bodies including the USA, EU, UK, Brazil, India, Japan, and international organizations like PIC/S, ISPE, and WHO. ✅ Like ✅ Repost ✅ Comment 👉 Follow us for more insights in the Life Sciences industry! #LifeSciences #CSV #Pharma #GlobalStandards #Compliance #Regulations #GAMP #AmaliaTech #AmaliaTechnologies Amalia Technologies Life Sciences, Simplified

𝘿𝙞𝙙 𝙮𝙤𝙪 𝙠𝙣𝙤𝙬 about the Evolution of Quality Assurance (QA) in Life Sciences? 🏥💡 The Life Sciences sector has experienced significant changes in Quality Assurance (QA) methodologies, with Computerized System Validation (CSV) and Computerized System Assurance (CSA) being the most recent developments. This history demonstrates how QA methodologies have adapted to meet the complex requirements of the Life Sciences sector, ensuring safety, compliance, and innovation. Are you intrigued by these developments? If this resonates with you, you can just hit that like, Repost or Comment button. ✅ Like ✅ Repost ✅ Comment 👉 Follow us for more insights in the Life Sciences industry! #DidYouKnow #QualityAssurance #LifeSciences #CSV #CSA #Regulations #GAMP #ISO #ICH #ScientificManagement #AmaliaTech #QualityAssurance #AmaliaTechnologies Amalia Technologies Life Sciences, Simplified

🚀 Transforming Drug Substance Development and Manufacture with ICH Guideline Q11 The pharmaceutical landscape is evolving rapidly, and at the heart of this evolution lies ICH Guideline Q11, shaping the development and manufacture of drug substances. Let's delve into the insights this guideline offers for optimizing processes and ensuring regulatory compliance. Embracing the principles outlined in ICH Guideline Q11 is crucial as the industry progresses, fostering innovation, maintaining quality standards, and ultimately enhancing patient outcomes. Examples of Implementation in ICH Guideline Q11: 🔍 Chemical Entities: Development and manufacture of chemical entities, including synthetic drugs, with a focus on optimizing synthetic routes and controlling impurities. 🔍 Biotechnological/Biological Entities: Guidelines for the development and manufacture of biotechnological and biological entities, including recombinant proteins and monoclonal antibodies, emphasizing process control and characterization. #DrugSubstanceDevelopment #ICHQ11 #PharmaInnovation #RegulatoryCompliance #ProcessOptimization #QualityManagement #AmaliaTech ✅ Like ✅ Repost ✅ Comment ☑ Follow us for more! Engaged in drug substance development? 💬Share your experiences and insights in the comments below! Seeking expert advice? 🤝Reach out to Niki Sorogas, PhD and Dimitra Kourtidou for tailored solutions!

𝘿𝙞𝙙 𝙮𝙤𝙪 𝙠𝙣𝙤𝙬 about the evolution of medical device regulations? 🏥💡A two-thousand-year journey through medical device regulation history shows constant innovation and exacting regulatory standards, all in the name of patient safety. Exciting, isn't it? Hit that like, repost or comment button if this resonated with you. ✅ Like ✅ Repost ✅ Comment ☑ Follow us for more captivating stories in the Life Sciences! Stay tuned! #DidYouKnow #MedicalDevices #Regulation #PatientSafety #Innovation #HealthcareTechnology #AmaliaTech

🚀 Revolutionizing Drug Manufacturing with Continuous Processes: A Deep Dive into ICH Guideline Q13 🌐💊 The pharmaceutical industry is at the forefront of a paradigm shift, embracing continuous manufacturing (CM) to redefine how drugs are produced. ICH Guideline Q13 offers profound insights into the scientific and regulatory facets of CM. As CM technology matures, its adoption promises to revolutionize the pharmaceutical industry—enhancing efficiency, elevating product quality, and improving patient outcomes. ICH Guideline Q13 stands as a roadmap. Embrace the transformative power of CM and contribute to shaping the future of pharmaceutical manufacturing. 🚀🌐💊 🌐 Examples of CM Processes in ICH Guideline Q13: 🔍 Continuous Direct Compression: Tablets produced continuously by feeding powders into a press, compressing them, and removing the tablets. 🔍 Continuous Crystallization: Crystals produced continuously by feeding a solution into a crystallization unit, allowing crystallization, and separating the crystals. 🔍 Continuous Solvent Evaporation: Solvents removed from a solution continuously by feeding it into an evaporator, extracting the solvent, and collecting the concentrated solution. #QSeriesSimplified #PharmaceuticalManufacturing #ContinuousManufacturing #ICHQ13 #RegulatoryCompliance #DrugDevelopment #AmaliaTech ✅ Like ✅ Repost ✅ Comment ☑ Follow us for more! Engaged in the pharma landscape? 💬 Let's discuss the innovations and results you've witnessed! Need guidance? 🤝 Reach out to Niki Sorogas, MSc, PhD and Dimitra Kourtidou for expert advice and solutions!

Let's Talk About Upcoming Deadlines in the Regulatory Landscape of EU 🔍 🌟 Regulation 2023/607: Key Requirements 🌟 By May 26, 2024, submit your application with a notified body designated for MDR for legacy devices. By September 26, 2024, establish a quality management system and agreement with the notified body. 🕒 Deadlines Approaching: The first deadline for Regulation 2023/607 is rapidly approaching. Manufacturers of legacy medical devices in the EU market will benefit from a regulatory reprieve if they meet certain conditions. 📅 Extended Timeframes for Legacy Devices: If compliant, legacy devices enjoy extended deadlines: December 31, 2027, for all class III devices and certain class IIb implantable devices. December 31, 2028, for class IIb non-implantable devices, class IIa devices, and class I Sterile/Measurement/Reusable surgical instruments. 📚 Resources: The European Commission has organized relevant documents under the "New Regulations" section, including Regulation 2023/607, EC Q&A, and templates for notified bodies. ⏳ Proposal for Legacy IVD Devices: The EC proposes to delay compliance for legacy In Vitro Diagnostic Devices (IVDs) and to roll out EUDAMED modules. Economic operators must notify competent authorities of device shortages. Remember: Application with a notified body is crucial for continued market placement. Compliance with deadlines is essential for legacy devices. 🔍 Clinical Trials' Transition to New EU System - One Year Left By 31 January 2025, all ongoing clinical trials in the EU must transition to the Clinical Trials Information System (CTIS), marking the end of a three-year transition period since the Clinical Trials Regulation (CTR) became applicable. Stay informed and ensure compliance with EU regulations! 💼 #MedicalDevices #EURegulations #ComplianceDeadline #ClinicalTrialsTransition ✅ Like ✅ Repost ✅ Comment ☑ Follow us for more!   Wondering how to handle the upcoming EU regulatory deadlines? Let's chat! We’re here to help! #AmaliaTech

🌐 Managing Compliance within the Evolving Landscape of the Drug Supply Chain Security Act (DSCSA) 🌐 The DSCSA is a critical initiative 📚 designed to safeguard 🛡️ the U.S. pharmaceutical supply chain from counterfeit, stolen, or contaminated drugs 💊. With a focus on enhancing traceability 🔎, the DSCSA timeline sets forth key milestones and requirements to establish an interoperable electronic 🖥️ system for the identification and tracing of prescription drugs across the nation 🗺️. 📅 DSCSA Timeline Highlights: - November 27, 2013: DSCSA Enacted - November 27, 2014: 3PLs Report Licensure Information Annually - November 27, 2015: Manufacturers Print Lot Numbers on Packaging - November 27, 2017: Manufacturers Serialize and Verify Products - November 27, 2018: Repackagers Serialize Products - September 23, 2019: FDA Delays Saleable Returns Requirement Enforcement - November 27, 2019: Wholesalers/Distributors Receive and Distribute Serialized Products - August 25, 2023: FDA Announces Extended Stabilization Period - November 27, 2024: Full Interoperable Electronic Unit-Level Traceability 🚀 The End Game - Full Interoperable Traceability: The ultimate objective of the DSCSA is achieving full interoperable electronic unit-level traceability for every regulated drug in the United States by November 27, 2024 ✅. Stakeholders, including manufacturers, wholesale distributors, dispensers, repackagers, and 3PLs, must have interoperable systems in place to share and verify package-level product identifier data electronically by this date. 🔍 Understanding DSCSA Compliance Requirements: The DSCSA compliance requirements vary based on stakeholder roles, and it's crucial to comprehend how these regulations impact you and your trading partners. The "four cornerstones" of DSCSA compliance encompass: 1️⃣ Product Identification (Serialization): Unique product identifiers (PI), like barcodes, must be electronically readable on certain prescription drug packages. 2️⃣ Product Tracing: Stakeholders must provide transaction information (TI) and transaction statements (TS) each time a drug is sold, outlining details like product name, strength, NDC, lot number, and more. 3️⃣ Verification: Systems and processes are required to verify PIs for specific prescription drug packages, with Verification Router Service (VRS) for saleable returns. 4️⃣ Authorized Trading Partners (ATPs): All stakeholders must be ATPs, meeting registration, licensing, and reporting requirements, while also ensuring the electronic verification of trading partners. Embrace these changes, understand your responsibilities, and collaborate with your trading partners to ensure seamless compliance with the evolving landscape of DSCSA regulations. 🤝💊 👇 Drop a comment below to share how you're preparing for DSCSA 2024, or hit 'like' to show support for a secure pharma supply chain. #DSCSA #PharmaCompliance #trackandtrace #Serialization #SupplyChainSecurity FDA #AmaliaTech