Rebecca Waterbury’s Post

The value of a thorough manufacturing record review is undeniable! Manufacturing records are not only a record of the manufacturing process, but also the official record of compliance to Good Manufacturing Practices, GMPs... Read more here: https://lnkd.in/gTYACUC3 #BatchWize #GMPManufacturing #MedTech #HealthTech #BatchRecordReview #QualityConsulting #FDARegulations #LifeScience

Today, Judy will host the "Good Manufacturing Practices Training | cGMP Course” for The Center for Professional Innovation & Education (CfPIE). Last chance to sign up. The course examines the ‘why’ of #cGMP principles along with valuable insights that will assist attendees in their quality decision-making, as well as demonstrating ways to make their present systems more effective. Learn more and find out why that it's one of CfPIE's most popular courses. https://lnkd.in/ebbRMUz4 #GMP #Compliance #Quality #Pharma

𝗥𝗲𝘃𝗶𝘀𝗲𝗱 𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲 𝗠 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 Application for grant of extension of compliance with Revised GMP under Schedule-M till 31 December, 2025 Small and medium manufacturers with turnover of or less than two hundred may seek extension of the timeline for implementation and for that purpose shall make an Central Licence Approving Authority in Form 'A' annexed to this notification within a period from the date of publication of this notification along with the plan of upgradation. For such timeline for implementation shall be extended till 31 December, 2025.

🌟 Your Guide To Pharmaceutical Excellence 🌟 Ever wondered what keeps the pharma world running smoothly behind the scenes? Here’s a peek into how CST VAL Consulting makes it happen: 🔍 Validation: We hunt down issues in processes, equipment, and systems to make sure everything is working smoothly 💧 Cleanroom Design and Construction: Cleanrooms are the VIP lounges of the pharmaceutical world. We help you build contamination-free spaces that keep products pristine and patients/ end users safe. ✅ Quality Assurance: From raw materials to manufacturing, we’re there every step of the way to make sure your products meet the highest standards. 🏆 🎓 Training Programs: We take training to a whole new level! Our interactive, hands-on sessions make learning exciting and transformative. (Register now for our upcoming Warehouse GMP, GDP, and GSP training ) Curious about how we can elevate your operations? Slide into our DMs or contact us today—because every great product needs an even greater process! 🚀 #PharmaFriday #Cleanroom #Validation #QualityAssurance #BehindTheScenesScience

Implementing Good Manufacturing Practice (GMP) regulations without compromising operational efficiency can be very challenging. Learn more about best practices and how to overcome common roadblocks. #gmp #lifesciences #biopharma

🌟 Behind Every Biogen Product: GMP Compliance You Can Trust! 💊 At Biogen, quality isn’t optional—it’s a promise. ✅ Our dedication to GMP (Good Manufacturing Practice) compliance ensures that every product is made with the highest standards of safety, quality, and efficacy. Here’s how we do it: ✨ Rigorous Testing: Every step of the process, from research to production, is carefully controlled. ✨ Expert Training: Our team stays up-to-date on GMP guidelines to deliver excellence. ✨ State-of-the-Art Facilities: Advanced manufacturing ensures consistent, reliable results. Why does this matter? 💡 GMP compliance guarantees that patients receive medications they can trust—safe, effective, and always reliable. Because your health deserves nothing less. 💪 Got questions about GMP or our practices? Drop them below! 👇 #GMPCompliance #BiogenQuality #PatientFirst #PharmaceuticalExcellence #TrustBiogen

It is best practice to assess and set a requalification schedule for facilities, systems, and process equipment. Regulations for drug product 21CFR211 as discussed in the blog below tells us to "assure proper performance". Guidance within ICH Q7a, Process Validation: General Principals and Practices, and other guidance documents note the need for evaluating the need for facilities, systems, and equipment to be maintained on a periodic basis. The periodic basis can be different from company to company based on their own evaluation and assessment of risk. Check out this blog. https://lnkd.in/eFzJGnUx

Scopri GMP - Good Manufacturing Practices, vantaggi e benefici. Scarica il white paper!📄 https://eh.digital/41fB1iE #gmp #QualityByDesign #EndressHauserItalia

EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol and other excipients at high-risk of DEG/EG contamination Updated Q&A - April 2024: 1. What is the background regarding international incidents of contamination of drug components with diethylene glycol (DEG) and ethylene glycol (EG)? H+V April 2024 2. How is the EU patient protected from similar contamination occurring in EU products? H+V April 2024 3. Can I use the derogations of Annex 8 of the GMP to sample only a portion of incoming containers of for glycerol, propylene glycol and macrogols (polyethylene glycol) with a relative molecular mass below 1000? H+V April 2024 4. What steps are expected of manufacturers and importers when purchasing excipients at high-risk of DEG/EG contamination? H+V April 2024 5. The European Pharmacopoeia limit test for DEG/EG involves a gas chromatographic method, which may be difficult to perform on a large number of containers. H+V April 2024 6. Are there any considerations applicable to the pharmaceutical assessment of marketing authorisation applications? H+V April 2024 7. My company manufactures products for external use. Does this guidance apply? H+V April 2024 #medicinalproducts #produktylecznicze #gmp #ffp Link: https://lnkd.in/dume5H_u

Understand the FDAs role in guiding pharmaceutical and med device manufacturers through effective and safe manufacturing practices.