• 2019-bl-thumb-proposed-ratings-system-measure-drugmakers

    The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

    A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.

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  • 2019-bl-thumb-no-1-fda-gmp-inspection-citation

    Different Year, Same Results: QA the No. 1 FDA Drug GMP Inspection Lapse for FY2019

    The latest statistics from U.S. Food and Drug Administration drug GMP inspection citations for FY2019 are making the headlines, and the most common cited reason for manufacturer receiving a warning letter is a familiar one. This article looks at how technology and the latest tools available to pharma manufacturers can significantly increase quality and compliance levels and reduce the likelihood of regulatory warnings.

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  • 2019-bl-thumb-ispe-and-mx

    Pharma Companies See Measurable ROI With Digitized Manufacturing

    Pharmaceutical manufacturing typically functions in a constant flurry of hard-to-satisfy demands, ranging from stringent compliance requirements and production schedules to developing strategies for continuous improvement. One of the presentations at the 2019 ISPE Annual Meeting and Expo, Oct. 27-30 in Las Vegas, will provide attendees with insight on how pharmaceutical companies are using digital technologies to avoid manufacturing obstacles while strengthening their competitive posture in the industry.

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  • 2019-bl-thumb-mice-habitat-impact-pharma

    Study: Effluvial Lodging for Mice Negatively Impacts Data Quality

    Researchers at the University of British Columbia (UBC) discovered that laboratory mice are not only biologically similar to humans, they also have similar aesthetic attributes. A recent study revealed that mice actually don’t like to sleep in sewage waste. Aside from affirming that mice might have some level of dignity and social grace, the study suggests that consistently exposing mice to “chronic averse stimuli” can negatively affect research data.

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  • 2020-bl-manufacturing-excellence-06_132x132

    A Guide to Pharmaceutical Quality by Design

    Quality by Design (QbD) continues to be a hot topic across the life sciences industries. As more of the pharma sector implements pharmaceutical QbD, regulatory bodies work to further develop a common understanding of key concepts, terminology and expectations.

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  • greater-operational-compliance-thumb

    Achieve Greater Operational Compliance and Efficiencies in Pharma Through IDMP Implementation

    The Identification of Medicinal Products (IDMP) is a set of ISO data standards that will help ensure that pharma organizations around the world speak the same language when it comes to product information and definitions. Find out how IDMP can also help improve your company’s internal quality processes.

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  • 2019-bl-thumb-3d-printing-of-pharmaceuticals

    3D Printing of Pharma Dosage Forms a Promising New Tech for Discovery

    Pharmaceutical manufacturers depend on innovation and new technologies to find new cost-effective ways of speeding up the drug development process. 3D printing (3DP) allows greater flexibility during the discovery process through rapid prototyping formulations and the potential for on-demand production of clinical samples. Learn how 3DP may change the way pharma does business.

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  • 2019-bl-thumb-manufacturing-batch-records-pains-v2

    EBR: Good for What Ails Your Batch Record Process

    Let’s face it, winter is a euphemism for cold and flu season. Much like these inconvenient and disruptive viral infections wreak havoc on the human body, paper-based batch record processes can infect a manufacturing floor, slowing and compromising an otherwise healthy operation. Fortunately, an electronic batch record (EBR) solution can cure the disease.

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  • 2018-bl-thumb-know-what-you-dont-know-about-drug-development

    The Importance of Knowing What You Don’t Know About Drug Development

    New drug development is Sunday drive, especially for startups. There can be costly mistakes and unanticipated roadblocks that pop up when you least expect it. Learn how to steer clear of hazards, what to do and who to talk to.

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  • 2018-bl-thumb-whats-hiding-in-your-labeling-artwork

    What's Hiding in Your Labeling Artwork?

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

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  • 2018-bl-thumb-ai-on-the-cusp-of-revolutionizing-pharmaceuticals

    Artificial Intelligence: Is It on the Cusp of Revolutionizing Pharmaceuticals?

    One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.

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  • 2018-bl-thumb-regulatory-barriers-for-biotech-medtech-startups-europe

    Regulatory Barriers to Innovation for Startups

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • 2018-bl-thumb-best-practices-supplier-evaluation-and-rationalization

    Best Practices for Supplier Evaluation and Rationalization

    Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.

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  • 2018-bl-thumb-how-ai-tools-transform-quality-mgt-in-life-sciences-part-2

    How AI Tools Will Transform Quality Management in the Life Sciences, Part 2

    The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers. Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.

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  • 2018-bl-thumb-how-ai-tools-transform-quality-mgt-in-life-sciences-part-1

    How AI Tools Will Transform Quality Management in the Life Sciences, Part 1

    FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.

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  • 2017-bl-thumb-what-is-doc-control-system

    What Biotech Startups Need to Do to Slay the Competition

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • 2018-bl-thumb-mc-top-clinical-pharma-bio-trends-to-date

    2018’s Top Clinical Pharma/Bio Trends to Date

    Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.

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  • 2020-bl-manufacturing-excellence-03_132x132

    Building a Vendor Qualification Program for FDA-Regulated Industries

    A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.

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  • 2018-bl-thumb-fda-back-cannabis

    FDA Backs Cannabis-Based Drug to Treat Kids With Epilepsy

    Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.

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  • 2018-bl-thumb-fda-top-10-gmp-inspection-citations-2017-part2

    FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

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