GxP Lifeline

 

Showing items tagged as Pharma

  • The Platform Advantage: Keys to Keeping Up With Pharma’s Top 4 Trends

    29 July 2020 By James Jardine, Staff Writer, MasterControl

    Software platforms are revolutionizing the quality function. What was once a guardrail for pharmaceutical and biotech companies is rapidly becoming a business accelerator that provides quantifiable competitive advantages. Discover how game-changing platforms are empowering leading companies to adapt to four predominant pharma industry trends by streamlining the management of data and quality processes.

    Full story

  • 5 Helpful Quality Event Management Tips From a CAPA Pro

    22 July 2020 By James Jardine, Staff Writer, MasterControl

    Expert consultant, Ken Peterson, offers best practices for quality event management systems (QMS) that will help you avoid “death by CAPA.”

    Full story

  • 4 Steps to Integrate Technology Into Your Pharma Supply Chain

    28 May 2020 by Mukul Dakwale, Principal Consultant, Luceats Consulting

    An array of advanced technology and digitization are rapidly changing the landscape of pharmaceutical manufacturers and their supply chains. Mukul Dakwale, principal consultant at Luceats, explains how formulating a digitization strategy and implementation plan can help your pharma company transition from disparate, manual data systems toward end-to-end automation.

    Full story

  • Top 5 Pharmaceutical Manufacturing Trends in 2020

    20 February 2020 by David Jensen, Staff Writer, MasterControl

    The pharma industry has been gathering no moss going into 2020. New pharmaceutical manufacturing trends have been rapidly emerging, accompanied by regulatory initiatives to help mainstream the innovations. A new trend brief from MasterControl discusses how the new trends will impact the pharma industry.

    Full story

  • The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

    11 December 2019 by Mike Rigert, Staff Writer, MasterControl

    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.

    Full story

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

    15 October 2019 by Mike Rigert, Staff Writer, MasterControl

    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.

    Full story

  • Pharma Companies See Measurable ROI With Digitized Manufacturing

    24 September 2019 by David Jensen, Staff Writer, MasterControl

    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.

    Full story

  • Novartis’ Data Manipulation Case a Cautionary Tale for Transparency Through Digitization

    12 September 2019 by Mike Rigert, Staff Writer, MasterControl

    Poor data integrity and data mismanagement can be costly for life science companies, delaying their products from getting to market, and in some cases, resulting in civil and criminal penalties. The Swiss pharmaceutical manufacturer Novartis is currently under fire after the FDA said the company falsified testing data prior to the release of its drug Zolgensma. It’s a cautionary note about why now, perhaps more than ever, greater transparency is needed in data management.

    Full story

  • Study: Effluvial Lodging for Mice Negatively Impacts Data Quality

    20 June 2019 by David Jensen, Staff Writer, MasterControl

    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.

    Full story

  • A Guide to Pharmaceutical Quality by Design

    16 May 2019 by Beth Pedersen, Staff Writer, MasterControl

    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.

    Full story

  • Achieve Greater Operational Compliance and Efficiencies in Pharma Through IDMP Implementation

    30 April 2019 by Frits Stulp, Managing Director, Iperion Life Sciences Consultancy

    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.

    Full story

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

    30 April 2019 by Jae D. Yoo, PhD, MBA, Chief Technology Officer, Aprecia Pharmaceuticals

    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.

    Full story

  • EBR: Good for What Ails Your Batch Record Process

    21 February 2019 by Beth Pedersen, Staff Writer, MasterControl

    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.

    Full story

  • Need Help With Vendor Selection? Don’t Pick Up the Phone Until You Answer 3 Simple Questions

    8 January 2019 by Ray Sison, VP of Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting

    Vendor selection in pharmaceutical manufacturing and related life sciences sectors is never an easy process. But incorporating comprehensive SOPs that answer three key questions can make for much smoother discussions during the selection process and contract negotiations.

    Full story

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

    4 December 2018 by Arvilla Trag, RAC, Consultant, BioProcess Technology

    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.

    Full story

  • What's Hiding in Your Labeling Artwork?

    23 October 2018 by Dan Vuksanovich, Regional Sales Manager, Schlafender Hase

    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.

    Full story

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

    21 August 2018 by Mike Rigert, Staff Writer, MasterControl

    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.

    Full story

  • Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 2

    15 August 2018 by Carla Frances Reed, President, New Creed

    A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

    Full story

  • Regulatory Barriers to Innovation for Startups

    31 July 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    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.

    Full story

  • Best Practices for Supplier Evaluation and Rationalization

    26 July 2018 by Carla Frances Reed, President, New Creed

    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.

    Full story