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Meet Regulation Requirements With RTU Vials And Cartridges Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment. Quality Management Fundamentals For Modern Compliance Manual quality processes can’t keep up with today’s compliance demands.
By Grant Mordue This article is the second in a two-part series about demonstrating cGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here, in Part 2, we turn our attention to the input data for an effective quality management review (QMR).
By Erich H. Bozenhardt and Herman F. Bozenhardt Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies. Sutro Biopharma CTO Shabbir Anik has contributed to 15 INDs and 10 NDAs over the course of his distinguished career.
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