Daniel Taylor

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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Have your say on updates to Good Manufacturing Practice (GMP) Guidelines. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’. These updates have been developed by a joint PIC/S and European Medicines Agency Inspectors Working Group, with input from the Therapeutic Goods Administration (TGA). If you’re an Australian manufacturer affected by these updates, your input is important. The PIC/S Guide to GMP is embedded in Australian law under the Therapeutic Goods Act 1989. It is the mandated standard for manufacturing therapeutic goods. Find out more: https://lnkd.in/gGeXyKMP

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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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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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Almac Group’s new GMP-qualified analytical stability chambers have officially opened at our Souderton, PA site! This $2 million investment builds on the multi-million-dollar expansion of global analytical services and reinforces Almac’s commitment to meeting growing client demand. Read more: https://hubs.li/Q03zWzQJ0 #cdmo #analyticaltesting #stabilitytesting #expansion

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“We’ve got audits under control.” That’s exactly what Alpex Pharma SA thought. 1. They had a skilled QA team. 2. A system that worked. 3. Processes they trusted. But then they looked closer: - Time lost chasing suppliers - Manual tracking of CAPAs - Stress during peak audit seasons After partnering with Qualifyze, they didn’t just improve. They transformed. ✔ 30% audit cost reduction ✔ 300+ hours of QA time freed up ✔ 90% of audits outsourced with full visibility and control ✔ A digital platform that removed admin friction entirely This isn’t about fixing something. It’s about raising the bar for quality management. 📥 Read the case study here: https://hubs.ly/Q03Bk6dS0 #AuditManagement #GMP #QualityAssurance #Pharma #CDMO #SupplierAudits #DigitalQA #OperationalExcellence #Qualifyze

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EU GMP Annex 11 Draft Revision 2025: A milestone for CSV projects? After more than a decade without change, Annex 11 is now facing a comprehensive revision. 🔎 What’s new in Annex 11: ✅ Expanded scope (from approx. 1.500 to over 10.000 words) ✅ New focus areas: Identity & Access Management and Cybersecurity ✅ Stronger emphasis on Audit Trails & Data Integrity ✅ More binding Supplier Management & Qualification / Validation activities At VTU, we believe: Annex 11 remains the cornerstone of CSV and the 2025 draft revision delivers valuable updates to enhance security, transparency, and reliability in complex system landscapes. But paper alone is not enough! By transforming requirements into practical solutions, we ensure CSV is not only compliant but also a catalyst for business success. 🚀 👉 Need a plan to implement Annex 11 updates? Use the link https://lnkd.in/d2ek4jCm to schedule a meeting with us. 💬 What are your expectations for the Annex 11 revision? #CSV #GAMP5 #Annex11 #Pharma #MedTech #Compliance #VTU

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