Nick Schuenemann

🚨 New FDA Draft Guidance Alert! 🚨 The FDA has released a draft guidance document titled "Considerations for Complying with 21 CFR 211.110". This guidance provides crucial insights into ensuring batch uniformity and drug product integrity, especially for those utilizing advanced manufacturing techniques. 🔍 Key Highlights: Ensuring batch uniformity and drug product integrity Incorporating process models into commercial manufacturing control strategies Quality considerations for advanced manufacturing 📄 Read the Draft Guidance Document: https://lnkd.in/ei2GZv87 At MMS, we understand the complexities of regulatory compliance and are here to help you navigate these requirements seamlessly. Our team of experts can assist you in implementing the necessary controls and strategies to ensure compliance with 21 CFR 211.110. 💡 How MMS Can Help: Comprehensive compliance assessments Customized control strategy development Advanced manufacturing support Let's work together to ensure your manufacturing processes meet the highest standards of quality and compliance. Contact us today to learn more about how we can support your compliance journey! #FDA #Compliance #Pharmaceuticals #AdvancedManufacturing #QualityAssurance #OneMMS

10

Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

3

Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

4

FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

1

FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

2

FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

1

Aligning with GMP Annex 1 updates can be overwhelming—but it doesn’t have to be. From risk management to contamination control, ensuring compliance while maintaining efficiency is no small task. Falling behind these new guidelines isn’t just a regulatory risk—it could compromise product safety and quality. 🔍 Ellab - Validation & Monitoring Solutions offers innovative tools designed to simplify Annex 1 compliance, helping you meet regulatory demands while ensuring exceptional product quality and safety. 👉 Read our blog now: https://lnkd.in/eP4SDc44) #Annex1 #RiskManagement #Compliance #Quality #Ellab

42

💡 Final version of FDA's Guidance "Advanced Manufacturing Technologies Designation Program" This guidance provides information about the process to request that an innovative pharmaceutical approach or technology that has the potential to improve the reliability and robustness of the manufacturing process and supply chain can be designated as an Advanced Manufacturing Technology (AMT)

1

Discover how Six Sigma transforms process validation for FDA compliance in our latest blog. Gain insights into effective strategies for life sciences companies to ensure product quality and operational efficiency. Read now for expert advice from...

1

Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities. 

290

10 Comments

The FDA's Center for Drug Evaluation and Research has released its latest report on the state of pharmaceutical quality. This report is a comprehensive overview that sheds light on the agency's efforts to ensure the safety, efficacy, and quality of drugs available to patients. In the report you can find topics including: -Trends in manufacturing quality and compliance. -Efforts to modernize manufacturing technologies. -Strategies to address challenges in global drug supply chains. Check out the full report below #PharmaceuticalQuality | #FDA | #DrugSafety | #RegulatoryCompliance #Healthcare | #CDER | #QualityAssurance | #IndustryInsights

6

Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

2

We live and breathe regulatory compliance. Azzur Group's GMP consultants are immersed in the standards set forth by the FDA, EMA, and other regulatory bodies including: ✅ 21 CFR Parts 11 and 820 ✅ FDA 2011 Process Validation Guideline ✅ Eudralex Volume 4 (EU cGMP Guideline) Have questions about your quality and compliance? Get your answers here: https://azzur.co/3xbIL8H #Compliance #GxPConsulting #LifeScience

20

Excited to share Chrissy Manley's insightful perspectives on the REMS logic model! Her expertise sheds light on the critical aspects of Risk Evaluation and Mitigation Strategies (REMS) and their impact on patient safety and regulatory compliance. If you’re navigating the REMS landscape and need expert support, reach out to MMS. We’re here to help you succeed in the REMS space! #REMS #RegulatoryCompliance #PatientSafety #MMSExcellence

1

ICYMI! 📢 Chrissy Manley recently shared insightful updates on the REMS Logic Model. This framework is essential for enhancing our understanding and implementation of risk management strategies. Don't miss out on these valuable insights that can drive better decision-making and outcomes. #RiskManagement #REMS #Innovation #MMS

3

Did you miss our latest blog outlining the differences between the new ICH M12 Guidelines and the 2020 FDA DDI Guidance? Read all about it here: https://hubs.ly/Q02DSm4M0 You can always browse our comprehensive catalogue of publications on our Science Pool: https://hubs.ly/Q02DSwXF0 Find everything you need in the Science Pool, including our webinars, case studies, posters and publications from across Evotec, Cyprotex, and Just Evotec Biologics. #Cyprotex #Pharma #DrugDevelopment #ClinicalResearch #ICHM12

3