ValSource Inc.’s Post

What's your Contamination Control Strategy (CCS)? Meeting the stringent requirements of the EU GMP Annex 1 can be a significant challenge. Reducing particle contamination is crucial for maintaining the highest standards in sterile medicinal product manufacturing. The updated EU GMP Annex 1 places a strong emphasis on environmental and process monitoring for both viable and non-viable particles. It mandates that risk assessments be thorough and scientifically justified, ensuring quality control through comprehensive monitoring systems and a robust Contamination Control Strategy (CCS). This strategy must be an active, evolving document, continuously updated to reflect the latest risk assessments and monitoring results. To help navigate these requirements, SCHOTT Pharma offers an insightful guide on the five essential steps for reducing particle contamination in RTU packaging. This blog post from my colleague Robert Lindner is a must-read for anyone looking to comply with the stringent EU standards and ensure the safety and efficacy of their products. Check out the full article here: https://lnkd.in/esRqM76W "5 Steps for Particle Reduction in RTU Packaging" and download the whitepaper. #SCHOTTpharma #adaptiQ #RtU

🔍 Spotlight on FDA Observations: Contamination/Aseptic Processing and Personnel 🔬 Three of the top ten areas with the most FDA observations are contamination, aseptic processing, and personnel. Key issues identified include: 📢 No Established Procedure: It is vital to have well-defined procedures to maintain aseptic conditions and ensure product safety. 📢 Inadequate Procedure: Procedures must be thorough and comprehensive to address all potential risks of contamination. 📢 Procedure Not Followed: Strict adherence to established protocols is crucial. Deviations can compromise the sterility and safety of the products. 📢 Inadequate or Missing Personnel Monitoring Data: Regular and precise monitoring of personnel involved in aseptic processes is necessary to prevent contamination. 📢 Lack of Controls Around Sterile Environments: Robust control measures must be in place to maintain the integrity of sterile environments. 🔬 Addressing these areas is not just about compliance but ensuring the highest standards of safety and efficacy in products. Let's commit to excellence in aseptic processing by: ✅ Establishing and continually refining comprehensive procedures. ✅ Ensuring strict adherence to protocols. ✅ Implementing rigorous personnel monitoring and training. ✅ Enhancing control measures around sterile environments. Together, we can meet and exceed regulatory expectations, safeguarding public health and maintaining trust in our industry. 🌟 I invite you to share your insights or questions on how to effectively address these challenges! 💬👇 #Pharmaceuticals #AsepticProcessing #QualitySystems #ContaminationControl #GMP 

Are you facing challenges in meeting the requirements outlined in Annex 1 for your early phase drug products? Dive into our whitepaper to discover how our sterile fill/finish services are designed to ensure compliance and precision. From Contamination Control Strategies to Pre-Use Post Sterilization Integrity Testing, we provide the expertise and technology to navigate the complexities of Annex 1. #eurofins #testingforlife #sterilefill #smallbatch #earlyphase

Last day to register is Friday, March 15. You don't want to miss this 2-hour virtual course. You will receive practical guidance on the requirements for the new Annex 1 2020 draft, with an emphasis on common testing errors. FDA 483 observations and case studies will highlight real-world risk scenarios and their impact on both products and patients. This course is part of a series of training to prepare a Contamination Control Strategy (CCS) for medicinal products that will comply with current regulatory thinking. The goal is to identify risks, spot gaps, and develop a mitigation strategy that will optimize contamination control. #contaminationcontrol #virtualclasses #CCS #pharma #regulatorycompliance #qualitycontrol #annex1 #FDA483 #riskmitigation

Don’t let environmental distractions impact #patientsafety in your pharmacy! Get expert advice on creating a safety net that will help all staff handle even the most stressful situations! Register today for our inaugural Safety Series webinar. Pharmapod Safety Series Ep 1: Creating Your Own Safety Net 🗓️ Wednesday, March 27 ⏰ 12 PM EST Hosted by: Carla Beaton Rhonda Kollenborn REGISTER HERE: https://ow.ly/yBr750R037v #PharmacySafety #MedicationSafety #MedicationReporting #Pharmacy #Pharmacists

Data visualization definitely makes a difference. Accessing it live is a game changer.

FDA Webinar: OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites

Calling all GMP Contamination Control Strategy experts!!!! I see plenty (99% +) of discussion for contamination control strategies for aseptic processes (especially in light of #annex1) but I rarely see discussions, webinars, or courses solely for non-sterile drug manufacturing. I only see the occasional mention of non-steriles (like the couple of lines in Annex1), but CCS is becoming an expectation for non-sterile manufacturers as well. I'd love to see an entire publication/course/webinar devoted SOLELY to non-steriles. Anyone out there setting one up? I have plenty of clients that would love to see this. Marsha Steed Jim Polarine Jim Agalloco Tony Cundell Marc Glogovsky Thierry Bonnevay Ziva Abraham Ulrich Herber Tim Sandle, Ph.D., CBiol, FIScT Karen Ginsbury Michael J. Miller, Ph.D. (sorry if I missed tagging anyone). #CCS #contaminationcontrolstrategy #nonsterilemicrobiology #gmp #pharmaceuticalmicrobiology #FDA #GMP

🔍 Spotlight on FDA Observations: Contamination/Aseptic Processing and Personnel 🔬 Three of the top ten areas with the most FDA observations are contamination, aseptic processing, and personnel. Key issues identified include: 📢 No Established Procedure: It is vital to have well-defined procedures to maintain aseptic conditions and ensure product safety. 📢 Inadequate Procedure: Procedures must be thorough and comprehensive to address all potential risks of contamination. 📢 Procedure Not Followed: Strict adherence to established protocols is crucial. Deviations can compromise the sterility and safety of the products. 📢 Inadequate or Missing Personnel Monitoring Data: Regular and precise monitoring of personnel involved in aseptic processes is necessary to prevent contamination. 📢 Lack of Controls Around Sterile Environments: Robust control measures must be in place to maintain the integrity of sterile environments. 🔬 Addressing these areas is not just about compliance but ensuring the highest standards of safety and efficacy in products. Let's commit to excellence in aseptic processing by: ✅ Establishing and continually refining comprehensive procedures. ✅ Ensuring strict adherence to protocols. ✅ Implementing rigorous personnel monitoring and training. ✅ Enhancing control measures around sterile environments. Together, we can meet and exceed regulatory expectations, safeguarding public health and maintaining trust in our industry. 🌟 I invite you to share your insights or questions on how to effectively address these challenges! 💬👇 #Pharmaceuticals #AsepticProcessing #QualitySystems #ContaminationControl #GMP 

You've reported an error or good catch in your pharmacy - what happens next? How can you leverage the data to prevent the situation from reoccurring? Join us NEXT WEDNESDAY for ep. 2 of our Safety Series webinars, as our experts Carla Beaton and Rhonda Kollenborn review Pharmapod’s powerful post-event analysis tools that will help you identify (and fix!) risks in your pharmacy. Register today! https://ow.ly/8ciM50S2bn0 📼 Can't make it live? Register to receive a recording. #PharmacySafety #Webinar #RootCause #CQI #Pharmacy #MedicationSafety #Pharmacists