FEATURE ARTICLES
Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.
- Chugai Accelerates Automation To Boost Operational Efficiency
- The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process
- CDMO Selection: Start With The Relationship, Not The RFP
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- What Reliance, Annex 1, And AI Mean For The Future Of GMP
- Applying Contamination Control By Design: A Practical Guide For CDMOs
- Navigating Rough Pharma Seas With Collaboration
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1462147534 manufacturing]( "5 Steps To Design A Microbiological Performance Qualification For Facilities")
5 Steps To Design A Microbiological Performance Qualification For FacilitiesExplore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
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Normalized Data In Microbial Continuous Monitoring7/24/2025
Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.
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Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?4/20/2026
Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.
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Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization12/2/2024
Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
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Is Sustainability The Key To Agile Biopharma Manufacturing?3/18/2025
In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines1/9/2026
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 06.11.26 -- USP And Fill/Finish Insights
- 06.11.26 -- Future Outlook: Technology And Innovation
- 06.11.26 -- STREAM Edition: Quality Control Failures And Solutions
- 06.10.26 -- New Insights Into ADC Analytical Strategies And Payload Innovation
- 06.10.26 -- Control Contamination In Material Transfer Process
INDUSTRY NEWS
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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.
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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
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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Veranova Appoints Dr. Bob Huang Vice President And General Manager Of West Deptford Site6/3/2026
Veranova today announced the appointment of Dr. Bob Huang as Vice President and General Manager for its West Deptford, New Jersey facility. He will lead site operations, advance strategic growth initiatives, and strengthen manufacturing excellence and customer delivery.
