Giovanni Curotto

Understanding ICH Quality Guidelines: A Quick Overview 🌍⚙️ The International Council for Harmonisation (ICH) Quality Guidelines are essential for ensuring the safety, efficacy, and quality of pharmaceuticals worldwide. Here's a quick summary to keep you informed: Watch NOW PHARMATALKS FULL Podcast HERE👉💯🔗😎 https://lnkd.in/dpCnEC7k Understanding ICH Quality Guidelines: A Quick Overview 🌍⚙️ The International Council for Harmonisation (ICH) Quality Guidelines are essential for ensuring the safety, efficacy, and quality of pharmaceuticals worldwide. Here's a quick summary to keep you informed: 1. Q1 Series (Stability Testing) 🧪 Focuses on stability testing protocols to determine shelf life and storage conditions. 2. Q2(R1) (Analytical Validation) 🔬 Provides guidance on validating analytical procedures to ensure accuracy and reliability. 3. Q3A/B (Impurities) 💊 Addresses impurities in drug substances and products, emphasizing control strategies. 4. Q4B (Pharmacopoeial Harmonization) 📚 Facilitates harmonization of monographs across different pharmacopoeias. 5. Q5 Series (Quality of Biotechnological/ Biological Products) 🧬 Covers quality considerations specific to biotech and biological products. 6. Q6A (Specifications for New Drugs) ✅ Sets standards for defining product specifications during development. 7. Q7 (Good Manufacturing Practice - GMP for APIs) 🏭 Guides manufacturing practices for active pharmaceutical ingredients. 8. Q8-Q11 (Pharmaceutical Development & Lifecycle Management) 🔄 Encompasses principles of quality by design, lifecycle management, and continuous improvement.

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Are Process Deviations Slowing You Down? Process deviations can derail production, trigger regulatory findings, and lead to costly delays. But with the right strategies, you can detect, classify, and prevent them like a pro. 👇 Here’s your quick checklist for GMP success: ✅ Understand the difference: deviation vs. variation ✅ Classify issues as minor, major, or critical ✅ Use tools for real-time detection and analysis ✅ Investigate thoroughly and apply strong CAPA ✅ Train staff and update SOPs regularly ✅ Involve Regulatory Affairs in deviation documentation ✅ Review deviation trends to prevent recurrence 📊 Stay audit-ready and quality-focused by mastering the full deviation workflow. 🎓 Want to upskill in deviation handling and compliance? 👉 Start here: Pharmuni’s Introduction to Regulatory Affairs https://lnkd.in/gQVnY8H4

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The FDA has finalized its new Quality Management System Regulation (QMSR) — fully harmonized with ISO 13485:2016 — with an effective date of February 2, 2026. ✅ One Quality System for FDA + international markets ✅ Streamlined global market access ✅ FDA inspections aligned with ISO 13485 While 2026 may feel distant, the time to act is now. Transitioning early ensures your organization is inspection-ready and positioned for global compliance success. At Nemko, we’re here to support with ISO 13485 certification audits, gap assessments, supplier audits, and integrated certification services. 🔗 Read the full blog to learn what this shift means for your business: https://lnkd.in/evAmF4Qf #MedicalDevices #FDA #ISO13485 #QMSR #GlobalMarketAccess #RegulatoryCompliance #Nemko

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Pharma manufacturing can’t afford inefficiencies. That’s where LabVantage Pharma LIMS transforms the game: ✅ Built-in compliance with FDA 21 CFR Part 11, EudraLex Annex 11 & global GxPs ✅ 75% faster implementation & 85% lower deployment costs ✅ Pre-validated & pharma-specific — ready to go live in as little as 90 days ✅ Automated batch release with instant CoAs & audit-ready reports ✅ Enterprise-grade security with encryption, access controls & audit trails From ensuring data integrity to accelerating batch release, LabVantage Pharma empowers manufacturers to deliver safe, high-quality products - faster and smarter. 📄 Download the whitepaper to know more: https://lnkd.in/gUfQYdYd #LabVantage #LIMS #PharmaManufacturing #LabInformatics #PharmaLIMS

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Pass Your First GMP Audit in QC Nail the basics. Show control. Prove data integrity. 🚀 Your 7-step playbook Prep: Current SOPs, training matrix, clear RACI. Records: ALCOA+ docs, real-time entries, version control. Methods & Equipment: Validations, IQ/OQ/PQ, calibration logs, standards traceability. Data Integrity: Audit trails, access control, backups, e-signatures, change control. Training & CAPA: Role-based refreshers, tight CAPA timelines. Mock Audit: Risk-based self-inspection, doc room, SME brief, evidence index. Audit Day: One voice, fast retrieval, clean narratives, calm execution. CTA — Get audit-ready now 📚 Build your GMP skills HERE: https://lnkd.in/dK5xJRd2

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