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樂朗小課堂 | PQRI與藥包材相容性E&L

PQRI（Product Quality Research Institute，產品質量研究所）成立于 1999 年，是一家非營利性組織聯盟，致力于及時、相關、有影響力的信息生成與共享，以提高全球藥品質量、制造和監管。

2023-09-12 08:55:34樂朗檢測763

PQRI與藥包材相容性E&L

PQRI（Product Quality Research Institute，產品質量研究所）成立于 1999 年，是一家非營利性組織聯盟，致力于及時、相關、有影響力的信息生成與共享，以提高全球藥品質量、制造和監管。（The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances global drug product quality, manufacturing and regulation.）

其成員主要有FDA / CDER（U.S. Food and Drug Administration, Center for Drug Evaluation and Research，美國食品藥品監督局/藥物評價研究中心）、USP（United States Pharmacopeia，美國藥典委員會）、PDA（Parenteral Drug Association，美國注射劑協會）、ELSIE（Extractables and Leachables Safety Information Exchange，可提取物與浸出物安全信息交換聯盟）等。

PQRI的口服吸入和鼻用藥物(OINDP)工作組于 2000年率先提出并于2006年率先公布了藥包材相容E&L的研究的重要安全閾值SCT、最佳實踐和試驗依據，包括基于安全性閾值的分析評估閾值AET、界定閾值QT等內容。之后，OINDP中E&L的閾值概念被外推至與非腸道和眼用藥物產品(PODP)相關的特定特征。

藥包材相容性E&L研究流程與PQRI的研究內容如下：

PQRI關于藥包材相容性E&L的相關文獻如下：

Time	Content
2006	Safety Thresholds and Best Practices for Extractables & Leachables in Orally Inhaled and Nasal Drug Products（OINDP）.
2007	Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug Product Evaluation.
2008	Best practices for extractables and leachables in orally inhaled and nasal drug products: an overview of the PQRI recommendations
2012	Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
2013	Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables
2013	Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
2013	Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
2013	Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
2016	Simulated Leaching (Migration) Study for a Model Container-closure System Applicable to Parenteral and Ophthalmic Drug Products (PODPs)
2021	Safety Thresholds and Best Demonstrated Practices for Extractables and Leachablesin Parenteral Drug Products (Intravenous, Subcutaneous,and Intramuscular)