Loyal’s Post

FDA announcing the publishing CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles Country: US https://lnkd.in/ewSkcdfC #FDA #regulatoryaffairs #healthcareinnovation #publishing #guidance #manufacturing #healthandwellness #medicalproducts #US

RxLogix Integrated Drug Safety Platform, where the rubber meets the road, plain & simple.

⏰ USP <665> is on the way! Are you ready? 🤝 Join our free webinar on February 28, 2024 to ensure the road to compliance.   👉 In the effort to support patient safety, USP general chapters <665> and <1665> have been officially approved in 2022 - with effective date to entering into force in May 1, 2026. Although this deadline seems to be far, USP <665> compliance is nowadays a mandatory information to be provided to the regulatory bodies.   🎯 Time to prepare is now! 👉 Join our experts Simone Carrara and Davide Tartaglione from Eurofins Regulatory & Consultancy Services Italy to gain a clear overview of USP <665>. You will understand how E&L can be most effectively managed through timely and meticulous evaluation for a successful transition.   💡 Details of the standard assessment and testing approach for qualification of plastic components and systems used in drug manufacturing will be discussed.   📈 Thanks to our outstanding analytical and toxicology assessment experience on E&L, across the largest panel of products, we will provide insights to avoid product withdraw from the market.   For more details: https://lnkd.in/gEMJV5CV   Local contacts: [email protected]   #USP #extractables #leachables #testing #SUS  

On August 25, 2023, Annex 1 of The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use becomes effective. The annex specifically covers Manufacture of Sterile Medicinal Products and replaces a previous version of the document which was in place since March 2009. The purpose of the update is “to reflect changes in regulatory and manufacturing environments and to remove ambiguity and inconsistencies and will take account of advances in technologies.” The new version is approximately three-fold longer than its predecessor, much of which is regarding the equipment used in aseptic preparation and processing. Here, we delve into the crucial topic of Annex 1 and provide valuable insights into its impact on your industry. Gain a deeper understanding of the requirements, guidelines, and best practices for compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators. #annex1 #sterilemanufacturing #pharma #biologicalindicators #pharmamanufacturing Mesa Laboratories, Inc.

A brand new blog for this month with some “ food for thought” for the industry. Take a quick read and let me know what you think.

The FDA has released a draft guidance document titled "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products." This guidance helps to understand how a Use-Related Risk Analysis (URRA) can be utilized to determine human factors data needs during product development and to support a marketing application. The FDA is encouraging everyone to review and provide comments by 09/09/2024. For detailed information, please click the link below. 👇👇👇👇 #pharma #biopharma #biotech #qualityassurance

Optimizing #rawmaterial selection so that you maintain #quality is critical to help achieve reliable and efficient #biologics #production. #CGMP #largemolecule #smallmolecule #biopharma #processdevelopment #qualitytechnician #supplychain 

Explore the latest insights on the article "Cleaning Validation Increasingly Under the Regulatory Spotlight" published by BioProcess International. ⏱️ Reading Time: 10 Minutes In an industry where patient safety is paramount, cleaning validation plays a crucial role. Learn about the regulatory requirements, challenges, and future trends shaping this essential process. Main takeaways: ✅ Regulations and Guidelines ✅ Change Over Time ✅ Challenges ✅ The Future of Cleaning Validation Read here:🔗 https://lnkd.in/exZyhJ4e Don't miss out on valuable expertise from Mirian J. Alvarez Berrios, QMC Director at Cencora PharmaLex US. #Pharamlex #PharmaceuticalManufacturing #RegulatoryComplianceth

Explore the latest insights on the article "Cleaning Validation Increasingly Under the Regulatory Spotlight" published by BioProcess International. ⏱️ Reading Time: 10 Minutes In an industry where patient safety is paramount, cleaning validation plays a crucial role. Learn about the regulatory requirements, challenges, and future trends shaping this essential process. Main takeaways: ✅ Regulations and Guidelines ✅ Change Over Time ✅ Challenges ✅ The Future of Cleaning Validation Read here:🔗 https://lnkd.in/g6Sr6nsE Don't miss out on valuable expertise from Mirian J. Alvarez Berrios, QMC Director at Cencora PharmaLex US. #Pharamlex #PharmaceuticalManufacturing #RegulatoryComplianceth

https://lnkd.in/e6Fmzqzc Once in a while we are reminded just how bad "drug” manufacturing can get. No we are not in some shabby neighborhood in some third world country. We are in fact within driving distance of a FDA office. When you mention maggots in a Warning Letter you have entered a world not fit for food much less drugs. These conditions underscore how industry can run away with extreme noncompliance and high risk when not monitored. One has to keep in mind just how much production takes place before and even after the FDA issues a Warning Letter. How much product made in these terrible conditions is released to the consumer. At times its months even a year plus after the conditions are documented. Another year at times when the conditions are exposed and the public is notified. Even after these terrible conditions are documented the risk continues with all the product that has been distributed. This people are not held fully accountable, they are not barred from doing it again, they don’t suffer exposure to prosecution, they are basically free to do it again. This is our consumer protection system at its worst.