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PQRI: Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular)

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The Product Quality Research Institute (PQRI) Leachables and Extractables (L&E) Working Group provided recommendations to the US Food and Drug Administration in 2006 on safety thresholds and best demonstrated practices for orally inhaled and nasal drug products (OINDP). The published PQRI E&L recommendations for OINDP have been globally referenced by regulatory authorities. Risk for package-product interaction is highest in OINDP; however, there is a high risk of package-product interaction in parenteral drug products (PDP) and subsequently safety thresholds and best practices specific for PDP were developed. Threshold concepts introduced by OINDP were extrapolated for PDP, are based on daily dose, and include the safety concern threshold (SCT), the analytical evaluation threshold (AET) for compound identification, and the qualification threshold (QT) for identified non mutagenic compounds. This document describes the E&L strategy for PDP and provides examples for small and large volume parenterals with additional considerations for biological products. Studies to support characterization of materials and simulation for intended use are described with justification for solvent selection, exposure conditions, extract concentrations and analyses. Contributions were made by over ninety individuals who are highly experienced scientists including toxicologists, analytical chemists, and others from industry, and government. It is the hope and intent of the Working Group that the recommendations contained within this document will serve to guide the pharmaceutical development process for PDP and facilitate the approval and manufacture of safe, effective, and quality medicines. The members of the PDP E&L Working Group acknowledge PQRI and its member organizations for providing this forum to make this collaboration possible and the dedicated scientists and regulators that provided the essential information to make these recommendations possible.

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Table of Contents:

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Part 1. Introduction and Summary of Recommendations
Part 2. Justification of Thresholds for Leachables in PDP
Part 3. Best Practices for Extractables and Leachables Assessment in PDP
Part 4. Special Topics: Considerations for Biological Products
Part 5. Appendices
List of Tables
List of Figures

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