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Follow the link below to learn more from RCA"s pharmaceutical consultants about the basics of aseptic processing while maintaining product effectiveness & safety. https://ow.ly/Ffs650QsjNK
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OQ Chemicals for sale? According to a Bloomberg report, the Omani state-owned OQ is preparing a sales process for its subsidiary, the German oxo alcohols producer OQ Chemicals. Read more: https://buff.ly/4fddseD #OQChemicals #OxoAlcohols #BusinessNews #OQ #MergersAndAcquisitions #ChemicalIndustry #BloombergReport
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👉Very few of us are familiar with the exact process & steps of direct compression. 👉For which products do we use direct compression method? 👉Merits and demerits of direct compression? Read all in following 👇👇 https://lnkd.in/dUwiST7j
Direct Compression for tablets - Pharmainform
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Announcement! 🔊 The Dow Chemical Company - Effective March 1st will increase the price for the following products: Aminoethylethanolamine (AEEA) Amine DCT Diethylenetriamine (DETA) Ethylenediamine (EDA) 👉 For more information visit our website: https://lnkd.in/eyupP83A Be sure to reach out to your dedicated GreenChem Sales Rep for further insight on how the latest chemical news might affect you. #chemicalnews #Dowchemical #Dow #Ethylenediamine #chemicaldistribution #GreenChem #GreenChemIndustryNews #addgreentoyourbottomline
Dow Chemical Price Increases, March 1st, 2024
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Don’t miss our free #webinar on regulatory trends for #chemicals and chemical products in Europe, the Middle East and Africa. Join us on 6 February to hear from Enhesa Product analysts. We’ll share the most important regulatory updates affecting compliance in EMEA, explore 2024 trends and highlight the hottest chemicals management issues. Register now! https://hubs.li/Q02jhnjZ0
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We have now arrived at DMF section 3.2.S.4 - so we're halfway through the whole DMF! This section describes the quality control of the API, including its specification, methods, validations, batch analysis and justification of specification. Watch the video to find out what are the expectations for each of these subsections: https://lnkd.in/dg7f78R4
DMF section 3.2.S.4 - Control of drug substance
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IPM conducts courses in RA, QA & short courses in Literature search, Nitrosamines, Genotoxicity, eCTD, India, LATAM submissions. IPM provides consultancy for regulated & emerging markets.
Best practices guide for managing suppliers of API manufacturers - Version 2 - March 18, 2024 This document's objective is to provide guidance and suggest a harmonized approach within the API industry on how to manage suppliers of materials and services in an adequate and compliant manner. The intention is to establish a supplier management framework that is not only compliant with the official requirements, but also covers other supplier management related aspects that play a role in real life, e. g. when dealing with suppliers that are reluctant to sign quality agreements or to accept physical audits. Although these other aspects are important, little detail is covered in official guidances, a gap which this ‘best practices’ guide is aiming to fill. In scope of this document are all third parties from which an API manufacturer purchases material or services that have a potential impact on the quality of the resulting API. This includes suppliers of materials, such as e.g.: starting materials, intermediates, reagents, solvents, packaging materials, processing aids. The principles of the guide could also be used for other materials such as equipment, spare parts, certain product contact materials (e.g. equipment gaskets, seals), suppliers of quality-relevant software - even though this is not the primary focus of this guide. It also includes providers of services, such as e.g.: contract laboratories, contract manufacturing, transportation, warehousing, calibration or critical IT services. Source Link: https://lnkd.in/ddiCexmn #pharmaceuticalindustry #pharmaupdates #news #regulatoryaffairs #ra
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Follow the link below to learn from RCA's regulatory compliance consultants about internal compliance for managing remediation & quality assurance expenses. https://ow.ly/kx6m50TCKS2
Remediation | Regulatory Compliance Consulting | RCA®
rcainc.com
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PG Diploma in RA, QA & short courses in Literature search, Nitrosamines, Genotoxicity, eCTD, India, LATAM submissions...IPM provides regulatory consultancy of API & Formulations for regulated & emerging markets.
Best practices guide for managing suppliers of API manufacturers - Version 2 - March 18, 2024 This document's objective is to provide guidance and suggest a harmonized approach within the API industry on how to manage suppliers of materials and services in an adequate and compliant manner. The intention is to establish a supplier management framework that is not only compliant with the official requirements, but also covers other supplier management related aspects that play a role in real life, e. g. when dealing with suppliers that are reluctant to sign quality agreements or to accept physical audits. Although these other aspects are important, little detail is covered in official guidances, a gap which this ‘best practices’ guide is aiming to fill. In scope of this document are all third parties from which an API manufacturer purchases material or services that have a potential impact on the quality of the resulting API. This includes suppliers of materials, such as e.g.: starting materials, intermediates, reagents, solvents, packaging materials, processing aids. The principles of the guide could also be used for other materials such as equipment, spare parts, certain product contact materials (e.g. equipment gaskets, seals), suppliers of quality-relevant software - even though this is not the primary focus of this guide. It also includes providers of services, such as e.g.: contract laboratories, contract manufacturing, transportation, warehousing, calibration or critical IT services. Source Link: https://lnkd.in/dQ6-s4Zv #pharmaceuticalindustry #pharmaupdates #news #regulatoryaffairs #ra
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A tiered approach should be applied to screening #chemical compounds for risks. Our expert discusses this approach and how it can be differentiated from regulatory testing. Watch the full webinar to learn more on this approach to predictive screening and using it to identify red flags early. https://okt.to/ZePvEt
Strategic Screening for Your Chemical Development Pipeline
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