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GxP Lifeline
  • 2023-bl-gxp-lifeline-contract-manufacturing-industry-trends_132x132

    Upgrade to Digital Supplier Management and Streamline Processes

    The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.

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  • 3 Tips for Effective Risk Analysis in the Medical Device Industry featured by MasterControl

    3 Tips for an Effective Medical Device Risk Analysis

    Medical device manufacturers need to manage risk from the beginning of product design and continue throughout the full product lifecycle - anything less jeopardizes product quality. Connected risk analysis is essential because it gives you a holistic view of risks and their potential impact. Having this level of visibility requires a digital quality management system.

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  • Supply chain best practices for the medical device industry

    Medical Device Supply Chain Backup

    It pays to have backup plans, and the supply chain is no different. Constantly fluctuating COVID-19 protocols and transportation issues continue to plague the medical device industry, but there are steps that can be taken to deal with these problems.

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  • 2021-bl-risk-based-approach-suppliers_132x132

    The Role of Supply Agreements in Life Sciences Manufacturing

    In light of the COVID-19 pandemic’s disruption to the global supply chain and the urgency around manufacturers quickly delivering life-saving products, it makes sense that manufacturing organizations and their supply partners might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners.

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  • 2021-bl-supplier-quality-agreements_132x132

    Supplier Quality Agreements 101: What, Who, and Why?

    Medical device manufacturers are ultimately responsible for the products they make and sell, even if they outsource some or all of their manufacturing or other operations. To ensure that products are safe and meet the claims made for them, regulatory bodies are looking to the companies that sell the product to have sufficient control over their suppliers. Quality agreements can go a long way to demonstrating the kinds of control that manufacturers have over their suppliers.

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  • 2021-bl-key-questions-quality-agreements_132x132

    5 Key Questions About Quality Agreements

    Quality agreements between organizations and contract manufacturing organizations (CMO), particularly in pharma, can be crucial to increasing ROI for a manufacturer. But there is a right way and a wrong way to approach quality agreements. Learn some best practices on how to produce more efficient and effective quality agreements.

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  • 2021-bl-qa-cupply-chain_132x132

    Supply Chains Q&A: What to Consider Before Making Changes

    If manufacturers want to move business away from China, or elsewhere, there are important considerations to take into account. Cynthia Kalina-Kaminsky, Ph.D. and owner and consultant for Process & Strategy Solutions, working with Quality Support Group, explains more in this Q&A.

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  • 2020-bl-thumb-spc-sqc

    SPC vs SQC: The Strategic Difference

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • 2020-bl-thumb-how-to-increase-the-value-of-your-supplier-audits

    How to Increase the Value of Your Supplier Audits

    A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely on its suppliers’ own quality-related activities. Leveraged correctly, supplier audits can be an important tool that gives manufacturers greater visibility into these activities, according to Quality Support Group CEO Angelo Scangas.

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  • 2020-bl-thumb-cmos-and-accenture-study

    Disruptive Outsourcing Means Life Sciences Are Relying on CMOs More Than Ever

    Life sciences manufacturers’ reliance on outsourcing is on an upward trajectory. However, recent disruptions to how and why companies turn to contract manufacturing organizations (CMOs) and related contract services are changing the playing field. To maintain quality and control of products in this more dynamic outsourcing ecosystem, companies should seek greater collaboration.

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  • 2019-bl-thumb-blockchain-technologys-role-in-manufacturing

    How Blockchain May Affect Manufacturing

    Although it’s a relatively new technology, blockchain has many promising use cases for manufacturers, and new applications of the technology are being introduced at an accelerated pace. Just as digital and cloud technology have caused a major disruption for paper-based enterprises, blockchain has emerged as the next-gen technology disruptor, meaning manufacturers must acknowledge and prepare for the transformation ahead.

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  • 2018-bl-thumb-top-5-nutraceutical-trends-qualifying-suppliers

    Using an Integrated QMS to Qualify Your Suppliers

    Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

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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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  • Supplier Qualification: An Important - and Often Neglected - Validation Component

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  • mc-logo-220x25

    Grid Analysis for Simplified Supplier Selection

    The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable.  Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs.  Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.

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  • mc-logo-220x25

    Elements of Effective Quality Agreements

    Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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