Rusken Packaging, Inc.’s Post

🚀 GMP: The Superhero of Pharma Manufacturing!🚀 Ever wonder how your medicines are always safe and effective? Enter GMP - Good Manufacturing Practices! Think of GMP as the superhero in the pharma world, ensuring every pill and potion is top-notch and trustworthy. 🌟💊 Good Manufacturing Practice is all about quality from start to finish. It's not just a rulebook but a commitment to making sure that what you take for your health, really does its job. And the best part? It keeps innovating, making medicines better and safer as science zooms forward. 🛠️🔬 So, next time you pick up your medicine, remember there's a hero behind the scenes - GMP, making sure your health is in good hands! 🦸♂️🦸♀️ #GMPHeroes #QualityCare #GMP

From this news post from RAPS, it appears the FDA inspection compliance OUS is improving/Improved. In May 2020, 93% of drug manufacturing facilities in the US had “acceptable” final outcomes following an inspection. In Europe, the acceptable compliance rate was 98%, 91% for China and 86% for India.   Yet by May 2023, the number of firms found compliant with GMPs in US dropped slightly to 92%. In Europe the percentage of firms with acceptable GMP compliance remained at 98%, in China the rate of acceptable outcomes rose to 95% and in India the rate rose to 97%. #compliance #enforcement #fdainspections #RAPS

As the cannabis landscape changes, so do regulations and because of this there has been an uptick in GMP projects and standards. We see this starting to dramatically increase in North America and as the rest of the world comes online for cannabis in some form of legalization, most are moving to GMP regulations of sorts. Whistler Technologies has designed equipment from DAY ONE to meet these standards. There have been many solventless extraction companies claiming they can meet these demands from GMP customers, but are being steered very wrong, costing time and money as well as failing to meet project deadlines. Whistler Technologies has delivered many GMP projects across the globe, including GACP, GMP, euGMP, and pharmaceutical niche projects and as far as I am aware, is the only solventless company to do so. (I would love to know if anyone else has delivered?) We are becoming both experts and the standard when it comes to delivering these projects. If you are currently working on upgrading your facility or building out for the GMP model, we would love to make sure you are set up properly for success. Pictured is our WT-CRAFT+ standard in all 316 stainless, washdown rated, sanitary and ready to go into a GMP facility. I would love to chat with anyone looking to deliver these sort of projects, please don't hesitate to ask questions! #gmp #sanitary #quality

FDA Insights: GMP Compliance Challenges and Enforcement Clarity Hand Sanitizer Impact: Hand sanitizer manufacturing during the pandemic lowered GMP compliance in the US, while other regions improved. Compliance Rates & Tools: US compliance dropped to 92%, while Europe, China, and India remained steady or improved. FDA relied on import alerts more than inspections. Enforcement Clarification: Warning letters and Form 483 reports aren't signs of failure. They signal potential GMP issues. Prepare for inspections with equipment and supplier qualifications, validated methods, and the right personnel. https://lnkd.in/gpkf_sS5) #FDACompliance #GMP #Pharmaceuticals #RegulatoryAffairs #QualityControl #Manufacturing #Healthcare #PublicHealth #COVID19Response #SafetyStandards #HandSanitizer #ImportAlerts #IndustryInsights #ComplianceMatters #FDAInspections #QualityAssurance #HealthcareRegulations #GlobalCompliance #DrugSafety #FDAUpdates

Pharma shipping-Key aspects 1. Packaging is crucial 2. Maintaining and tracking pharmaceutical temperatures as required 3. Choosing the right shipping mode(air, road or ocean) 4. Understand the laws and regulations 5. Keep proper licensing 6. Documentation is important  7. Stay insured while on transit 8. Hygiene and handling procedure a must 9. Security is paramount 10.Telematics for cold chain monitoring #freghtwayspharma #freightwayssolutions

#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!

EU GMP Annex 1 aims to enhance sterile medicinal product manufacturing. Learn more about the services that are required prior to final aseptic preparations and processes and how we can support you. Find out more here: https://rb.gy/xc6yfr #compliance #qualitymanagement #healthcare

In LogiCare3PL’s latest blog, read about the importance of regulatory compliance and how it impacts your supply chain. From understanding cGMP to navigating the intricacies of DSCSA, we provide expert insights and guidance to help you stay ahead. #DSCSA #LC3PL #supplychain #logistics https://lnkd.in/ezTqRdEz

Part of Annex 1 compliance, and in particular Contamination Control Strategy, can be executed successfully either internally or by partnering with external suppliers (or both!). #EUGMPAnnex1 #SteriPack

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