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Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps

Executive Summary

Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.

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...manufacturers are exploring how quality-by-design concepts apply in the context of the complexities of the drug/device interface. The challenges surrounding the control of leachables and extractables and how the supplier relationships fit into the QbD effort are particular focal points of attention. New industry guidances on L&Es and supplier GMPs from the Product Quality Research Institute and the International Pharmaceutical Aerosol Consortium on Regulation and Science, respectively, are helping move the dialogue forward and tighten the communication linkages. [Summary reports from three breakout sessions at a recent IPAC-RS conference – on supplier quality control, parametric tolerance interval testing and application of ISO standards – are provided.]

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