We're excited to be exhibiting at ISPE Singapore, one of the premier pharmaceutical manufacturing shows in Singapore for pharmaceutical and biomanufacturing professionals happening at the Suntec City Convention Center on August 29-30, 2024. Ensuring compliance with Good Manufacturing Practices (GMP) is crucial in the pharmaceutical and other regulated industries. Don't miss our Lunch & Learn session where we'll be sharing on the Best Practices for GMP Compliant Monitoring of Compressed Air Systems in Pharmaceutical Industry. Our oil-free compressors are designed to meet these strict standards, offering a reliable and clean source of air for your critical processes. Secure your complimentary trade visitor pass here 👉 https://lnkd.in/d-4GXhM4 #IngersollRand #ISPESingapore24 #OilFreeCompressors #GMPCompliance #GMP #aircompressors #pharmaceutical #GMP #manufacturing
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Key Requirements for Metal Detection in the Pharmaceutical Industry Metal detection plays a crucial role in ensuring the safety and quality of pharmaceutical products. The pharmaceutical industry demands stringent controls to comply with regulatory standards and protect consumers from potential hazards. Implementing effective metal detection systems is essential to identify and eliminate metal contaminants throughout the manufacturing process. This article discusses the key requirements for metal detection in the pharmaceutical industry, focusing on equipment specifications, regulatory compliance, and best practices. Read the full article: https://loom.ly/ceOuZ2I #pharmaindustry #metaldetection #pharmaprocess #qualitycontrol
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Key Requirements for Metal Detection in the Pharmaceutical Industry Metal detection plays a crucial role in ensuring the safety and quality of pharmaceutical products. The pharmaceutical industry demands stringent controls to comply with regulatory standards and protect consumers from potential hazards. Implementing effective metal detection systems is essential to identify and eliminate metal contaminants throughout the manufacturing process. This article discusses the key requirements for metal detection in the pharmaceutical industry, focusing on equipment specifications, regulatory compliance, and best practices. Read the full article: https://loom.ly/ceOuZ2I #pharmaindustry #metaldetection #pharmaprocess #qualitycontrol
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How can pharmaceutical companies benefit from data-driven optimization strategies? When dealing with legacy processes that lack comprehensive development data, pharmaceutical companies can face significant challenges such as low process capability, high costs, and insufficient data for optimization. This was the case for a pharmaceutical company facing withdrawal of their GMP license due to significant batch variability. To tackle this challenge, our R&D team developed a comprehensive strategy, ultimately yielding tangible results: A close to 100% reduction of API content variation and a reduction of batch scrap rate from 40% to 10%. The efforts of our R&D team demonstrated the importance of data-driven optimization strategies in the pharmaceutical industry. Want to see the breakdown of our approach? Read the full case article here: https://lnkd.in/dqDQzfZw #Pharma #GMP #DataDriven
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This comprehensive guide offers valuable insights into the best practices for excipient development and distribution. It's an essential resource for pharmaceutical manufacturers, distributors, and users, aiming to harmonize international excipient standards. The guide is globally applicable, and provides a useful tool for companies auditing the supply chain of pharmaceutical excipients. It's an indispensable tool for achieving an equivalent level of assurance for excipient quality. #PharmaceuticalIndustry #Excipients #GoodDistributionPractices #AuditGuide #PharmaceuticalManufacturing #PharmaceuticalDistribution #QualityAssurance #IPEC #PharmaceuticalStandards #SupplyChain #QualityControl #CommercialQuality #QualityManagement #PharmaSupplyChain #PharmaQuality
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🔍Explore Expert Resources: Extractables & leachables testing in accordance with USP 1663 and USP 1664. Dive deeper into these assessments and discover their impact on drug safety. In the realm of pharmaceutical safety, extractables and leachables assessments are essential for both development and regulatory submissions. Guidelines such as <1663> and USP <1664> are key documents governing extractables testing and assessment of leachables, ensuring the safety of pharmaceutical packaging and delivery systems. This requires rigorous assessment of potential interactions between drug formulations and the materials used in packaging. By identifying and quantifying potentially harmful substances that can migrate from packaging materials into drug products, manufacturers can mitigate risks associated with product contamination, stability issues, and patient safety concerns. Learn more: https://lnkd.in/e-2i8CMS #USP1663 #USP1664 #extractables #leachables #Intertek
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A comprehensive Standard Operating Procedure (SOP) on Distribution and Transport Validation in the pharmaceutical industry. This SOP provides detailed steps for conducting transport validation, evaluating product integrity, and assessing the impact of environmental conditions on the quality of finished pharmaceutical products. It covers everything from the objective and scope to the responsibilities of different departments, revalidation criteria, and acceptance criteria. A must-read for professionals involved in the pharmaceutical supply chain. #PharmaceuticalIndustry #SupplyChain #TransportValidation #QualityAssurance #CommercialQuality #GoodDistributionPractices #GoodStoragePractices #TemperatureMonitoring
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Commercial Lead @ OneSC (One Supply Chain) | Pharmaceutical Supply Chain Expert @ AssureBio - Recruiting Quality Assurance & QP Professionals - Pharma & Biotech
Excited to share the Certificate in Pharmaceutical Quality program, which follows the US FDA's six systems approach to quality. Tailored for professionals in pharmaceutical operations, particularly quality departments, this program consists of nine virtual instructor-led courses. To earn the Certificate, participants must complete one course from each system. #NSF #PharmaceuticalQuality #ProfessionalDevelopment
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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.
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of May 1, 2024. Source Link: https://lnkd.in/d5gh4M-u #regulatoryaffairs #ra #pharma #pharmaceuticalindustry #guidanceforindustry #cep #edqm
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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.
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of May 1, 2024. Source Link: https://lnkd.in/dDDZyDFE #regulatoryaffairs #ra #pharma #pharmaceuticalindustry #guidanceforindustry #cep #edqm
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Commercial Lead @ OneSC (One Supply Chain) | Pharmaceutical Supply Chain Expert @ AssureBio - Recruiting Quality Assurance & QP Professionals - Pharma & Biotech
Excited to share the Certificate in Pharmaceutical Quality program, which follows the US FDA's six systems approach to quality. Tailored for professionals in pharmaceutical operations, particularly quality departments, this program consists of nine virtual instructor-led courses. To earn the Certificate, participants must complete one course from each system. #NSF #PharmaceuticalQuality #ProfessionalDevelopment
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