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30 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook February 2024 PharmTech.com Qualit y erence standard qualification process is and how long it will last in line with stability plans. Assays are such a critical component of quality be- cause they are used to guide process development, re- lease the product, inform stability, and to demonstrate process robustness. Too much variability in the assay will result in sub-optimal decisions and may result in a lower yielding process and longer-term operational costs. A process with narrow critical quality attributes (CQAs) and high variability in the analytical method is one that will have a high rate of batch deviations and pos- sibly batch rejections. Generally, if the variability within the assay is 70% of the CQA range, good batches can be expected to fail on a regular basis. This is a problem that is easily avoided by better planning early in the process. Conclusion Confidence in a CDMO can mean the difference be- tween a positive experience and wasting a lot of effort providing oversight to either have product delays or need to find a new vendor. When setting this relation- ship up, think about whether the CDMO has the experi- ence needed and people you want to work with. Ensure that they have the bandwidth to support the project for the life of the product. And look for partners that un- derstand process needs and have a similar ethos when planning for and meeting regulatory compliance. Open dialogue with a CDMO that is like minded is the best way to keep processes running smoothly. These are long-term relationships that need to be clearly defined and mutually beneficial to get ad- vanced therapies to where they are needed so people can live better and longer lives. ■ Somnath Mishra, President, Shabas Solutions LLC FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations In this episode of the Drug Solutions Podcast, Chris Spivey interviews ex- ecutives at Shabas Solutions LLC, who ran the overseas QMM pilot project. FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for cur- rent good manufacturing practice (CGMP) compliance. In this podcast, learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabas Solutions LLC, who ran the overseas pilot program. Shabas Solutions provides bio-medical scientific and technical services, management advisory services, medical logistics and supply chain management support, financial management support, technology integration, and training, and communication and outreach to federal government agencies. Shabas is a large-scale, departmental level mission- support operation with expertise in policy, operations, and systems. The company offers pharmaceutical consulting across drug discovery and development (small molecules and biologics), pharmaceutical manufacturing QMM, pharmaceutical products storage and distribution, and regulatory affairs. The company maintains an ISO 9001:2015 certified quality management system and a DCAA-approved accounting system. For more podcast episodes, visit our website! Zachary Royal, Senior Consultant, Shabas Solutions LLC Robert Michalik, Advisor, Quality and Corporate Compliance, Shabas Solutions LLC William Hauck, Senior Associate, Shabas Solutions LLC Clyde Schultz, Senior Associate, Shabas Solutions LLC Open dialogue with a CDMO that is like minded is the best way to keep processes running smoothly. About the Drug Solutions Podcast Pharmaceutical Technology presents the Drug Solutions podcast, where the editors chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the tech- nologies, to strategies, to regulations related to the development and manu- facture of drug products.