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Successfully Navigating Opportunities With On-Body Delivery Systems – Common Questions And Answers
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Container Closure Integrity (CCI) is essential to ensure sterile drug products remain safe, effective, and contamination-free throughout their shelf life. USP <1207> recommends evaluating package integrity from development through commercialization by defining the Maximum Allowable Leakage Limit (MALL) and selecting validated, application-specific test methods. The guidance favors quantitative deterministic methods over probabilistic approaches and emphasizes integrating CCI testing, seal quality assessment, stability studies, and lifecycle management to maintain product quality.
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By Gunjan Bagla, Amritt Inc.
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India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten manufacturing license timelines while preserving quality, safety, and performance requirements.
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2026 Manufacturing Trends Reshaping Life Sciences
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Webinar | MasterControl, Inc.
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Explore the manufacturing trends shaping 2026, from AI in validated environments to connected systems and digital workforce readiness that are building more agile, resilient, and compliant operations.
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Webinar: AI-Readiness In A Regulated World: A Practical Playbook For Life Sciences
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Learn how to build an AI-ready quality strategy without compromising compliance. In this webinar, MasterControl shares practical guidance for implementing AI governance in regulated life sciences, including human-in-the-loop design, AI-specific SOPs, change control, ISO 42001 certification, and evolving regulatory expectations. Gain actionable recommendations to strengthen compliance, audit readiness, and responsible AI adoption across your organization with confidence. Click here to learn more.
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