GxP Lifeline

 

Showing items tagged as Pharma

  • A Risk-Based Approach to Validation

    December 30, 2020 By Peter Knauer, Managing Partner and Co-Founder, Sage BioPartners

    Updated guidances for process validation suggest using a risk-based life cycle management approach with relevant scientific rationale and evidence in lieu of a traditional top-down comprehensive approach. This article presents an approach to risk management for successfully meeting the regulatory guidelines for validation.

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  • Five Best Practices for Ensuring Supplier Quality

    December 21, 2020 By David Jensen, Staff Writer, MasterControl

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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  • What Is Pharmaceutical Quality by Design?

    November 24, 2020 by Beth Pedersen, Technical Writer, MasterControl

    Approximately one out of every 10 drug products make it to market. Pharma companies are striving to improve that statistic by implementing more effective quality and risk management measures. Quality by Design (QbD) is one of those measures and it’s becoming more widely adopted by manufacturers in the life sciences industry.

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

    November 5, 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.

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  • 5 Helpful Quality Event Management Tips From a CAPA Pro

    July 22, 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.”

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  • 4 Steps to Integrate Technology Into Your Pharma Supply Chain

    May 28, 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.

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  • Top 5 Pharmaceutical Manufacturing Trends in 2020

    February 20, 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.

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

    December 11, 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.

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

    October 15, 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.

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  • Pharma Companies See Measurable ROI With Digitized Manufacturing

    September 24, 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.

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  • Study: Effluvial Lodging for Mice Negatively Impacts Data Quality

    June 20, 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.

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  • A Guide to Pharmaceutical Quality by Design

    May 16, 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.

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

    April 30, 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.

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

    April 30, 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.

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  • EBR: Good for What Ails Your Batch Record Process

    February 21, 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.

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

    December 4, 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.

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  • What's Hiding in Your Labeling Artwork?

    October 23, 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.

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

    August 21, 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.

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  • Regulatory Barriers to Innovation for Startups

    July 31, 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.

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  • Best Practices for Supplier Evaluation and Rationalization

    July 26, 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.

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