FEATURE ARTICLES
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
- Controls For Retrieval-Augmented Generation In GxP
- FDA Issues New Guidance On Therapeutic Equivalence
- July 2026 — CDMO Opportunities And Threats Report
- ADC CDMO Selection For Small Biotech
- Implementing AI Solutions In GMP While Managing Risk
- Can U.S. Policy Bring Generic Drug Manufacturing Back Home?
- Implementing And Optimizing Your eQMS
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1287845246-laboratory-bottles-mask-scientist-gloves-coat]( "Advances In Regulations For Viable Environmental Monitoring")
Advances In Regulations For Viable Environmental MonitoringViable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
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Building Excellence In Pharma Manufacturing Through Rigor8/16/2025
A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. Learn how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.
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When To Consider Material And Personnel Airlocks For Downflow Booths3/20/2026
Strategic use of airlocks in downflow booth design enhances pressure stability and containment. A risk-based approach ensures facility integration meets rigorous safety and compliance standards.
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Digital Maturity In Life Sciences Quality And Manufacturing6/17/2025
Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.
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Quality: The Link Between Platform, Processes, And Patients2/18/2025
Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.
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Handling Protocols: Key Considerations In The Highly Potent API Market5/12/2025
Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 09.01.26 -- Implementing And Optimizing Your eQMS
- 08.30.26 -- AI Needs Human Oversight To Better GMP Documentation
- 08.28.26 -- Capabilities For Choosing The Right CDMO For Cell Line Development Success
- 08.28.26 -- A Much-Improved Approach For Understanding And Managing Safety Risks
- 08.27.26 -- Meeting Modern Challenges In Ophthalmic Drug Delivery
INDUSTRY NEWS
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![white coupon banner, great topic-GettyImages-2271702407]( "Let Your Voice Help Shape Pharma Manufacturing")
Let Your Voice Help Shape Pharma ManufacturingPharmaceutical Online hosts live virtual panels with industry experts on important topics and challenges, and we want to know what topics are important to you. Please consider taking a few minutes of your time to tell us what they are.
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![rating service, satisfaction-GettyImages-2221603596]( "ISPE Announces 2026 FOYA Winners")
ISPE Announces 2026 FOYA WinnersThese awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
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![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.
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![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.
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![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough North America led the market with a 38.32% market share of $3.15 billion in 2024, Asia Pacific is expected to have the fastest growth in the upcoming years.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Explore how sterility assurance, including sterilization validation and environmental monitoring, is essential for controlling microbial contamination in mammalian cell production to ensure patient safety. Check out the latest e-book from Pharmaceutical Online.
More Content CollectionsSUPPLIER NEWS
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JHS And Altoura Selected For BioTools Innovator VANGUARD Level Up-XR Program8/28/2026
Jubilant HollisterStier(JHS) and Altoura will be of only three company-CDMO pairs participating in the BioTools Innovator VANGUARD Level Up-XR Program.
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Syntegon Launches New Pilot Scale Tablet Coater For Small Batches8/26/2026
Syntegon, a strategic lifecycle partner to the pharmaceutical and biotech industry has expanded its Oral Solid Dosage (OSD) processing portfolio with the Sepion 75. The new pilot-scale tablet coater designed to support manufacturers and CDMOs in handling growing product diversity, smaller and more variable batch sizes, and stricter containment requirements for highly potent active ingredients. The new coater completes the established Sepion series and supports consistent scale-up, faster flexible batch processing, and containment-oriented manufacturing.
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Cambrex High Point Completes FDA, PMDA And TGA PreApproval Inspections, Advancing Commercial Manufacturing Capabilities8/25/2026
Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced the successful completion of three Pre-Approval Inspections (PAIs) at its High Point, North Carolina facility by the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA). The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia, establishing the facility as the newest commercial manufacturing site within the Cambrex global network.
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CleanSpace Names Pharma Industry Veteran Will Knapp Midwest Sales Director8/25/2026
Will Knapp joins CleanSpace as Director of Sales for the Midwest, bringing morethan 25 years of pharma facility design, construction, and validation expertise.
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METTLER TOLEDO Introduces LightningBuild Program For Four-Week Delivery8/13/2026
METTLER TOLEDO Product Inspection Group introduces its LightningBuild program, which delivers select product inspection systems from purchase order to the customer’s dock within four weeks. The program is launching with the X12 LightningBuild x-ray inspection system and the C31 LightningBuild checkweigher, both on exhibit for the first time at Pack Expo in booth 2122. Available at no additional charge, LightningBuild is designed for food and pharmaceutical manufacturers that need to start, expand or adapt operations quickly.
