Syntegon’s Post

Great news - we’ll be moving forwards with adoption of PIC/S Guide to GMP version 16. The document includes changes to Annex 13 (IMPs) as well as adoption of Annex 16 Certification by the Authorised Person and batch release. It’s a document everyone involved in manufacturing and supply should be aware of. https://lnkd.in/gGQkHCPy

EU Experts Urge Sterile Drugmakers to Conduct Annex 1 Gap Assessment: Sterile drugmakers seeking to comply with new EU GMP guidelines introduced in August 2023 should consider an in-depth gap assessment in their facilities — working through the guidelines line by line, two EU regulatory experts advised. #fda #financial #lifesciences

Which role do companies like SKAN play in shaping the future of sterile medicinal products under the revised EU GMP Annex 1? 👉 Discover exclusive insights from two renowned former regulators in our interview. Watch the full video here: https://bit.ly/46MTGS3 #SKAN #Annex1 #SKANannex1 #ContaminationControl #MedicinalProducts

🎉 We're thrilled to share that our recorded webinar on EU GMP Annex 1 (draft 2020) and How it Affects Aseptic Manufacturing is now available for your viewing convenience. Given the significant changes outlined in the 2020 draft of EU GMP Annex 1, it's crucial for pharmaceutical professionals to stay informed and adaptable. Our webinar provides valuable insights into navigating these changes effectively. 🔗 Access the recorded webinar here: https://lnkd.in/gbMJr5JV By watching, you'll learn about: 🧪 The essential personnel involved in preparing an Environmental Monitoring (EM) program and their roles in risk management. 🔄 How recent manufacturing trends in sterile products will impact your EM practices. 📊 Effective strategies for managing data, conducting analysis, and implementing predictive workflows to enhance EM program efficiency. Feel free to watch at a time that suits you best. We encourage you to seize this opportunity to equip yourself with the knowledge necessary for compliance in pharmaceutical operations.

In the highly regulated #pharmaceutical and medical device industries, even the smallest inconsistencies can lead to serious #product issues. As #weighing instruments and applications are present in almost every stage of a #manufacturing workflow, they can strongly influence the quality and integrity of the final product. Attend this knowledge sharing webinar to gain more insights. #mettlertoledo

#MettlerToledoWebinar | This webinar explains what calibration and qualification of weighing instruments are and why these related concepts are important for Good Manufacturing Practice. Register now!

Knock knock…. FDA here! How does your team prepare for audits amidst regulatory changes and evolving standards? Join us at the 4th Annual Pharma GMP and Quality Management 2024 for interactive sessions featuring 5 Scenarios + 5 Responses, equipping your team to face audits confidently! #eminencegroupventures #eminencebusinessmedia #ebmgmp4

A very important topic, especially for SMID companies - stage appropriate GMP is what is necessary, don't go for full blown cGMP for phase I studies, but at the same time do not neglect the basic requirements, otherwise you might run into issues at a later stage. My team of QMC experts is here to help you finding the happy middle ground!

#MettlerToledoWebinar | Make sure your weighing results are ✔️reliable while satisfying GMP requirements. Join our free webinar on #Calibration and #Qualification and learn how you can achieve it. Register now ❗ https://okt.to/BMF3Gb

#MettlerToledoWebinar | Make sure your weighing results are ✔️reliable while satisfying GMP requirements. Join our free webinar on #Calibration and #Qualification and learn how you can achieve it. Register now ❗ https://okt.to/dHEBDm