elm-plastic GmbH’s Post

Hi Ashwini Deshpande, 𝗖𝗼𝗻𝗴𝗿𝗮𝘁𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀, 𝗮𝗻𝗱 𝘄𝗲𝗹𝗹 𝗱𝗼𝗻𝗲 𝗼𝗻 𝘁𝗵𝗶𝘀. Ashwini covered the following areas on this programme: - Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation - Industry regulations and guidelines for GMPs – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation - FDA medical device rules – medical device regulations & and guidelines - GMPs vs ISO 9001:2015 – what’s the difference and why we use both - Process validation and documentation – design and verification of manufacturing systems - Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic and sterile manufacturing - Supporting technologies  – such as purified water generation, storage and distribution, clean steam, water for injection, storage and distribution - Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application - Working in a cleanroom environment – layout, classification, gowning and monitoring - Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry For an end-of-module assignment, Ashwini completed a 1200-word report on the cGMPs that are required to consistently manufacture safe medicines, vaccines and medical devices for patients. It included: - The key requirements of a quality management system - The cleaning validation sequence and how to determine cleanliness levels - The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk. - The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients - The generation, storage and distribution of pharmacopoeia grade Purified Water (PUW). - The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment Well done again.

Navigating the world of FDA-approved specifications and ISO standards can feel like a maze. But imagine having a label and packaging partner by your side, guiding you through each requirement and ensuring you meet all regulatory standards effortlessly. The right partner can give you peace of mind knowing your labels and packaging are compliant and safe. Learn more: https://bit.ly/4dMPWnU #RLGHealthcare #Pharmaceuticals #LabelSolutions #PackagingSolutions

📢Explore our blog post "𝐇𝐨𝐰 𝐚𝐫𝐞 𝐃𝐫𝐮𝐠/𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐢𝐧 𝐭𝐡𝐞 𝐔𝐒𝐀 𝐛𝐲 𝐭𝐡𝐞 𝐅𝐃𝐀?" and discover the regulatory landscape governing these crucial products. Read it here 👉https://lnkd.in/eCyTEjDy Stay informed and navigate the complexities of FDA regulations with ease. #FDA #Pharmaceuticals #MedicalDevices DrugDeviceCombinationProducts

This Video is self explainatory. After watching this Video, please ask yourself. Have you evaluated the cGXP computerised system by independant agency? #pharma #pharmaceuticals #compliance #CSV #computerisedsystem

"Delighted to announce my completion of the Drug Recalls course! 🎓 Exploring the FDA's role, recall classes, and historical cases has been eye-opening. Excited to apply this knowledge as I embark on my journey in pharmacy. PharmaState.Academy #DrugRecalls #FDA #Pharmaceuticals #SafetyFirst #HealthcareCompliance #DrugSafety #MedicalRegulation #ProfessionalDevelopment "

📢 Exciting News! The US FDA has released a new guidance document detailing recommendations for adequate reporting categories and the content of postapproval change submissions related to Container Closure System and Component Changes (Vials and Stoppers). This comprehensive guidance aims to streamline regulatory submissions and ensure product quality and safety. Stay informed and ensure compliance with the latest FDA recommendations! #FDA #Pharmaceuticals #RegulatoryAffairs #QualityControl #Healthcare 🔗 [https://lnkd.in/dedZaNAv]

Navigating DSCSA exceptions has never been easier! With TrackTraceIT, maintaining accurate documentation and staying aligned with FDA regulations is a breeze. Our solution ensures compliance with DSCSA requirements and the FD&C Act, helping you manage exceptions effectively. Trust TrackTraceIT for reliable, seamless, and efficient handling of your pharmaceutical documentation needs. #DSCSA #PharmaceuticalCompliance #FDARegulations #TrackTraceIT #ComplianceSolutions

To guarantee safety, pharmaceutical labels must contain essential information and clear consumer instructions. Alongside our stringent adherence to FDA regulations and Good Manufacturing Practices (cGMP), Oliver offers anti-counterfeiting designs to protect the integrity of your products. Ensure peace of mind for both you and your customers. Learn More About Pharma Labels and Packaging-https://hubs.li/Q02zlmLC0 #PharmaceuticalSafety #LabelingStandards #FDACompliance #cGMP #AntiCounterfeiting #ProductIntegrity #PharmaLabels #OliverSolutions #RegulatoryCompliance #PharmaceuticalQuality #OliverPharma

This Video is self explainatory. After watching this Video, please ask yourself. Have you evaluated the cGXP computerised system by independant agency? #pharma #pharmaceuticals #compliance #CSV #computerisedsystem

From Compliance to Lifesaving: The Importance of Optimizing Artwork Approval Processes in Pharma and Med Device Efficient artwork approval processes are crucial in various industries, especially in pharmaceutical and medical device sectors. By implementing efficient workflows and ensuring compliance with cGMP, companies can reap numerous benefits such as successful product submissions, timely launches, improved patient health and safety, minimized risks of recalls, and prolonged product lifecycles. Go deeper into the significance of efficient artwork approval processes for Pharma and Med Device here: https://lnkd.in/dNxwZkwH