NNIT ’s Post

UPCOMING WEBINAR: #FHIR and the Pharmaceutical Quality Standard 📅 Date: July 12, 2024 🕐 Time: 1:00 pm EDT | 10:00 am PST Dive deeper into the future of #pharma innovation in session 3 of our FHIR-Side Chats Series with Craig Anderson, Director and R&D Lead of the International Labeling Group at Pfizer. In this illuminating session, Craig will share his insights on implementing the FHIR standard, along with its benefits and use cases. You'll also get an exclusive look at the cutting-edge FHIR-based Pharmaceutical Quality Data Standard and how it's setting new benchmarks for industry excellence. 🔗Register here: https://okt.to/ST8RpP Your Presenters: Craig Anderson, Director and R&D Lead of the International Labeling Group at Pfizer Kare Hyttel, Principal Consultant, Regulatory Affairs, NNIT What you'll gain: ✅ In-depth understanding of the FHIR standard and its applications ✅ Insights into the innovative FHIR-based Pharmaceutical Quality Data Standards ✅ A forward-looking vision for regulatory activities rooted in structured data standards #PharmaInnovation #FHIR #Webinar #LifeSciences #PharmaceuticalQuality #RegulatoryAffairs #DataStandards #PharmaLeaders

The recent Annex 1 revision by the European Medicines Agency’s Good Manufacturing Practices (EMA GMP) poses significant challenges for the pharmaceutical industry regarding particulate contamination in injectables drugs. Discover how Aptar Pharma's PremiumFill®, manufactured in ISO-classified cleanrooms, is helping our customers meet these challenges. A recent case study demonstrates how a partner reduced scrap levels by more than 20% by switching from a standard vial stopper to a to PremiumFill® vial stopper. In the latest issue of Drug Development & Delivery, Aptar Pharma’s Audrey Chardonnet discusses the implications of these industry shifts and how pharma manufacturers must adapt their supply chains by selecting better quality injectable closure components and switching to Ready-to-Use gamma sterilized components. Read the full article here: https://ow.ly/xvrp50PLFOZ #ContaminationControlStrategies #CCS #GMP #Annex1 #Pharma #PremiumFill #Vial #PFS #FillandFinish

𝗥𝗲𝗴𝘂𝗹𝗮��𝗼𝗿𝘆 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀 𝗨𝗽𝗱𝗮𝘁𝗲 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟬𝟱 𝗖𝗗𝗦𝗖𝗢 𝗿𝗲𝗹𝗲𝗮𝘀𝗲𝘀 𝗱𝗿𝗮𝗳𝘁 𝗚𝗗𝗣 𝗴𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 ✓ Distribution and storage are essential activity in the integrated supply-chain management of pharmaceutical products. Various individuals and entities are generally responsible for the handling, storage and distribution of such products. ✓ CDSCO had introduced guidelines on good distribution practices for biological products vide Document No: CDSCO/GDP.BP Ver.: 00 Effective Date: 08/10/2012.Later, the draft guidelines on Good Distribution Practices for Pharmaceutical products was published / circulated on 25/09/2018 through Notice vide F. No. 15-14/2018-DC ✓ This document prepared in line with WHO TRS on Good Storage and Distribution practices ( TRS 1025 - Annex 7: Good storage and distribution practices for medical products) for Pharmaceutical products sets out steps to assist in fulfilling the responsibilities involved in the different stages within the supply chain and to avoid the introduction of spurious, adulterated, misbranded and not of standard quality products into the market. ✓ This document elaborates the procedures to be followed in transportation, shipping, labelling, dispatch and receipt of the pharma products and documentation related to distribution. It also details the methods to file complaints, for recalls and returns, and the handling of spurious, misbranded, adulterated and NSQ pharma products, among others. #learning #gdp #cdsco #gmp #pharma #healthcare #gmp #qms #qa

Exciting to share a new certificate obtained from US Food and drugs FDA. Honored to have participated in the "Towards Global IDMP Implementation: A Focus on Global Use Cases" conference. Engaging with experts and discussing the vital role of IDMP in standardizing medicinal product information globally was enlightening. Grateful for the opportunity to contribute and learn about diverse use cases shaping the pharmaceutical landscape. Looking forward to continued collaboration in advancing IDMP implementation! #Pharma #GlobalHealth #IDMP #clinicaltrials #learningeveryday #foodasmedicine #fdaapproval #DataStandardization #certificationachievement

The pharmaceutical industry is rapidly evolving, and your auditing skills need to keep pace. From maintaining regulatory compliance to supply chain integrity, pharmaceutical supply chain auditing is challenging in many respects. But worry not, Scilife has organized another training session next month! 🎯Training: Achieve Excellence with Effective Auditing 🗓️ Date: 18/06/2023 ⏰ Time: 11:00H CEST Here’s what you'll learn: 🔹 Key stakeholders in the pharmaceutical supply chain & auditing 🔹 Essential auditor qualifications and skills 🔹 Insights from 4 practical case studies: API Manufacturer (GMP), Distributor/Carrier (GDP), Sterile FDF Manufacturer, Packaging Material Manufacturer In this insightful training session, industry experts will tackle the challenges of auditing in the pharmaceutical supply chain and provide you with all the best practices to enhance your auditing processes and ensure compliance. ➡ Don't miss out! Register now to secure your spot: https://hubs.li/Q02yXCjl0 #ScilifeTraining #PharmaceuticalAuditing #PharmaSupplyChain #ContinousLearning

Susan Schniepp talks about quality systems and how to handle audits - See the full interview here:https://lnkd.in/esQqPExM For advanced therapy medicinal products hashtag #atmps in particular, Schniepp emphasizes how fast-moving this sector is. “The regulations don't keep up with the ATMPs. That technology, and their way of thinking, is turning over quicker than the regulations,” she says. “The changes in the regulations that are going to come are going to be around quality culture and maintaining a robust quality management system,” she adds. Ensuring documentation and keeping equipment calibrated are important practices to apply to these new fast-moving ATMPs, she states. Schniepp does not necessarily expect to see many changes in the regulations around ATMP development and manufacturing but thinks that there will likely be more guidance documents issued in the future, with one of FDA’s focuses being its quality management maturity model. “There are some regulations out there that call out quality culture. In particular, the World Health Organization has one on data integrity. It has a definition and standard[s] on what quality culture is,” Schniepp says. She points out that a new aspect of her presentation at INTERPHEX this year is its interactive component, in which she sets up a scenario involving an audit where an incident occurs. She gives the audience three potential responses to discuss, but rather than simply asking them which response do they pick or which response is correct, she instead asks what does the chosen response say about that person or that company’s QMS and the maturity of that system? thanks also to INTERPHEX Global American Association of Pharmaceutical Scientists (AAPS) | @aapscomms PDA - Parenteral Drug Association Pharmaceutical Technology #fda #ema #regulations #QMS #pharmamanufacturing #regualtorycompliance #cGMP

Have you missed our recent Joint EDQM-USP Webinar on “Secondary standards - Considerations in traceability to pharmacopeial standards”? Pharmacopoeial Reference Standards are a cornerstone of pharmaceutical quality control. But what about secondary standards? In a brief 36-minute webinar, explore the intricacies of using secondary standards and ensuring precise metrological traceability. 📈 💡 Key takeaways: 🔹 Practical insights for pharmaceutical professionals 🔹 How to reduce risk and avoid common pitfalls 📽️ The recorded video is now available for free! Watch it now! 👇 https://lnkd.in/eAhRDDfH #WorldStandardsWeek

Embarking on a pharmaceutical venture with a CDMO? Ensure success by having these crucial documents ready! 1️⃣ MSDS Documents: Get Material Safety Data Sheets directly from your vendor to avoid delays and obstacles. 2️⃣ Safety Assessment Documents: Streamline the process by providing completed safety information on your API, including the preliminary OEB rating. 3️⃣ Regulatory Statements: Don't let regulatory hurdles slow you down. Ensure all necessary statements for your API are completed. 4️⃣ API Solubility: Provide solubility information on the API upfront to ensure a seamless progression through established timelines. 5️⃣ API Reference Standards: Hand over API reference standard documentation to eliminate any roadblocks. 6️⃣ Potential Daily Exposure Documents (PDEs): Share PDEs early to equip the CDMO to make informed decisions. Preparation is key to progress in pharmaceutical development. Keep these documents close, and you'll be one step closer to a successful partnership with your chosen CDMO. #PharmaManufacturing #Biopharmaceuticals #PharmaceuticalDevelopment

We are proud to announce the launch of our extensively updated and upgraded #OTCIngredientsDirectory ✨ ! Our free-access database allows users to compare the classification status (prescription vs. non-prescription) of active pharmaceutical ingredients (APIs) in Europe. It is a unique tool and an indispensable resource for industry professionals and regulators. Besides new functionalities, our updated directory provides: ⚕ Legal status of 269 APIs, highlighting recent switches and back switches across 30 EU markets 🗺 Expanded market coverage, including additions from Cyprus, Latvia, Luxembourg, and Malta 🔎 Detailed analysis of 2,520 products with non-prescription status across 48 ATC therapeutic areas Read our full press release here: https://lnkd.in/ePFGrwPP 📅 Save the date and join us for an #ExclusiveWebinar on 2 July to know more about the Directory: https://lnkd.in/eG2JVp9y