Recent PDA Technical Reports:
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This TR describes the proven, successful principles used and measures that can be taken to mitigate the risk of contamination by viruses. It also provides guidance in effective preparation and response should such an event occur in manufacturing processes using in vitro mammalian or other eukaryotic cell cultures to produce biopharmaceutical products.
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This TR describes the underlying mechanisms and contributing factors of low endotoxin recovery (LER), summarizes the potential clinical impact of the LER phenomenon, presents guidelines for developing LER hold-time study design, and provides strategies for the mitigation of LER.
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This TR focuses on the development of a risk-based control strategy adapted to cell-based therapy that can mitigate the risks of generating a product of poor quality.
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Gain the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the laboratory. This TR outlines regulatory requirements and expectations and best industry practices to ensure data integrity, to highlight common gaps in laboratory data management practices, and to recommend methods of remediation.
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This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.
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