Featured Pharma Online Editorial
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How Is Your Glass Supplier Adapting To Europe's Energy Crisis?
11/3/2026
Europe's glass manufacturers, including those making pharmaceutical lab glassware, have experienced a series of energy shocks. Many have adopted sustainability practices.
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Is Your Supply Chain Ready For The End Of Class VI?
10/21/2026
Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
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Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
10/2/2026
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
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FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
10/1/2026
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
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FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
3/19/2026
FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.
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Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
3/17/2026
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
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The Transition To E-Labeling Is More Than Uploading PDFs
10/31/2025
Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.
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New Guide Aims To Build Robust Framework For Digital Validation Tools
10/22/2025
The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.
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The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma
9/15/2025
As the industry faces increasing pressure to align with environmental, social, and governance (ESG) standards, companies must evaluate how to integrate supply chain management with these initiatives to drive sustainability and mitigate risks.
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Managing Extractables And Leachables In HPAPI Manufacturing
7/10/2025
These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.