Search results for " pharmaceutical"
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Operational Excellence: More Than Just Process Improvement
FDA Commissioner Margaret Hamburg told participants at the Annual Meeting of the Generic Pharmaceutical Manufacturers Association that the agency will increasingly focus on GMPs to improve drug qualit…
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Essentials in Quality Risk Management
ICH Q6, Q8, Q9, Q10, and Q11 detail the pharmaceutical development process and how to set limits (1-5). The QRM process is linked to product and process CQAs because they are the quality attributes of…
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Quality Considerations for Using AI in Bio/Pharma
Schneipp is distinguished fellow at Regulatory Compliance Associates and a member of Pharmaceutical Technology®'s Editorial Advisory Board.
Siegfried Schmitt is vice president, Technical at Parexe…
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Eliminating Residual Impurities Starts with a Strategic Plan
…ation agents, inorganic or organic contaminants from permanent and single-use process equipment, the pharmaceutical formulation, and/or a breach of sterility. “A strategy for the control of residual …
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Based on this forecast, the industry expects cell and gene therapy products to surge in the market and remain a prominent part of the pharmaceutical industry for years to come (2).
FDA has devel…
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An Analytical Approach to Biosimilar Drug Development
Although analytical scientists have long been immersed in the traditional field of small-molecule pharmaceuticals, they are increasingly required to shift focus to large-molecule characterization and …
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Understanding Validation and Technical Transfer, Part 3
ICH Q9 provides a comprehensive discussion of quality risk management and risk management tools that apply to pharmaceutical and biopharmaceutical quality (9).
Maintaining the validated state o…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Yu, deputy director of the Office of Pharmaceutical Quality in FDA’s Center for Drug Evaluation and Research, talked about the future of pharmaceutical quality—and the challenges of achieving quality …
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Industry Adoption of Single-Use Systems Remains Low
Conservative attitude
Conservative attitudes tend to dominate the pharmaceutical and biopharmaceutical industries, which have traditionally resulted in slow adoption of newer manufacturing tec…
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Transformative Medicines Challenge FDA and Manufacturers
Biopharma manufacturers thus face additional challenges in working with device makers to devise, test, and produce reliable and efficient combination products, commented Bret Coldren, director of phar…