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由Smithers主辦的第八屆E&L亞洲年會將于2025年6月26-27日在新加坡舉行。在年會召開之前，Smithers采訪了 USP 藥物科學(xué)通則與復(fù)雜仿制藥部門總監(jiān) Prabhakar Reddy 博士以及高級首席科學(xué)家 Ravi Kiran Kaja 博士，提前了解他們即將在大會上聯(lián)合分享的演講內(nèi)容——《Updates on the Finalized System Suitability Standards Proposal from USP for the analysis of Organic Extractables & Leachables》。詳細(xì)問答如下，請以英文為準(zhǔn)，中文翻譯僅供參考。

Questions 提問 &Answers 解答

Q1: Why is this message particularly critical for industry professionals to hear right now?

這條信息為何對于行業(yè)專業(yè)人士而言在當(dāng)下尤為重要？

A1: Currently, there are no compendial or regulatory system suitability standards specifically designed for Extractables and Leachables (E&L) screening studies. This gap has led to inconsistencies in data quality, method performance, and regulatory compliance across laboratories worldwide. Given the complexity of analytical platforms like GC-MS and LC-MS, ensuring that instruments are functioning optimally before screening is essential. Without standardized system suitability checks, critical compounds may go undetected—posing potential safety risks to patients.

目前，并沒有專門為提取物和浸出物(E&L) 篩選研究設(shè)計(jì)的藥典或法規(guī)系統(tǒng)適用性標(biāo)準(zhǔn)。這一缺失導(dǎo)致全球?qū)嶒?yàn)室之間的數(shù)據(jù)質(zhì)量、方法性能和法規(guī)合規(guī)性存在不一致性。鑒于像GC-MS 和 LC-MS 這樣的分析平臺的復(fù)雜性，在篩選之前確保儀器正常運(yùn)作是至關(guān)重要的。沒有標(biāo)準(zhǔn)化的系統(tǒng)適用性檢查，關(guān)鍵化合物可能會未被檢測到——這對患者構(gòu)成潛在的安全風(fēng)險(xiǎn)。

Recognizing this need, USP initiated a global effort in 2021 to develop robust, scientifically justified system suitability standards. This initiative was strongly supported by stakeholders through multiple surveys and culminated in a comprehensive round robin study involving 15+ global labs. The finalized set of standards now includes chemically diverse mixtures tailored for key analytical methods (Direct and Headspace GC-MS, LC-MS with ESI and APCI), with compounds selected to assess sensitivity, specificity, linearity, and chromatographic performance.

鑒于這一需求，美國藥典委員會(USP) 于2021年發(fā)起了一項(xiàng)全球性努力，以制定強(qiáng)有力且科學(xué)合理的系統(tǒng)適用性標(biāo)準(zhǔn)。該倡議得到了利益相關(guān)者的大力支持，經(jīng)過多次調(diào)查，最終在包括超過15個(gè)全球?qū)嶒?yàn)室的綜合循環(huán)試驗(yàn)中圓滿完成。最終制定的標(biāo)準(zhǔn)包括專為關(guān)鍵分析方法（直接和頂空GC-MS、帶ESI和APCI的LC-MS）量身定制的化學(xué)多樣化混合物，這些化合物被選用來評估靈敏度、特異性、線性和色譜性能。

This message is especially timely as USP prepares to publish a second stimuli article and considers integrating these standards into General Chapter <1663>. For industry professionals, adopting these standards will not only enhance confidence in E&L data but also support global harmonization, regulatory acceptance, and ultimately, patient safety.

這條信息尤其及時(shí)，因?yàn)槊绹幍湮瘑T會(USP) 正準(zhǔn)備發(fā)布第二篇刺激性文章，并考慮將這些標(biāo)準(zhǔn)整合到章節(jié)<1663> 中。對于行業(yè)專業(yè)人士來說，采用這些標(biāo)準(zhǔn)不僅會提升對E&L 數(shù)據(jù)的信心，還將支持全球協(xié)調(diào)、法規(guī)認(rèn)可，并最終保障患者安全。

Q2: With evolving guidelines like USP <1663> and ICH Q3E, how do you foresee the regulatory landscape for E&L testing changing in the short future?

隨著 USP <1663> 和 ICH Q3E 等指導(dǎo)原則的發(fā)展，您如何預(yù)見 E&L 測試的法規(guī)環(huán)境在不久的將來會發(fā)生怎樣的變化？

A2: The regulatory landscape for E&L testing is on the cusp of significant transformation. While ICH Q3E is still under development, its eventual release is expected to bring global alignment and clarity to extractables and leachables testing and reporting, especially for complex drug products and delivery systems. In parallel, USP has proactively engaged the global scientific community through a comprehensive stakeholder survey to evaluate the relevance and scope of its current chapters, <1663> and <1664>. The feedback was clear: there is a strong demand to modernize these chapters to reflect recent scientific advances and to broaden their applicability to emerging modalities and complex materials.

E&L 測試的法規(guī)環(huán)境正處于重大變革的邊緣。雖然ICH Q3E 仍在開發(fā)中，但其最終發(fā)布預(yù)計(jì)將帶來全球一致性和明確性，特別是在復(fù)雜藥物產(chǎn)品和遞送系統(tǒng)的提取物和浸出物測試及報(bào)告方面。與此同時(shí)，USP積極通過全面的利益相關(guān)者調(diào)查，與全球科學(xué)界合作，以評估其當(dāng)前章節(jié)<1663> 和<1664> 的相關(guān)性和范圍。反饋意見明確：迫切需要對這些章節(jié)進(jìn)行現(xiàn)代化改造，以反映最新的科學(xué)進(jìn)展，并擴(kuò)大其在新興模式和復(fù)雜材料方面的適用性。

In response, USP plans to initiate a major revision of these chapters starting in early 2026, following the formation of a new expert committee as part of the next revision cycle. These updates are expected to integrate new system suitability standards, address complex product categories, and align more closely with evolving international expectations.

作為回應(yīng)，USP 計(jì)劃在2026年初啟動這些章節(jié)的重大修訂，這將由新的專家委員會在下一次修訂周期中進(jìn)行。這些更新預(yù)計(jì)將整合新的系統(tǒng)適用性標(biāo)準(zhǔn)，解決復(fù)雜產(chǎn)品類別問題，并更緊密地與不斷發(fā)展的國際期望保持一致。

In short, we are entering a pivotal era where harmonized, science-driven standards will elevate consistency, reliability, and regulatory confidence in E&L testing worldwide.

簡而言之，我們正進(jìn)入一個(gè)關(guān)鍵時(shí)期，其中和諧的、科學(xué)驅(qū)動的標(biāo)準(zhǔn)將提升全球E&L 測試的一致性、可靠性和法規(guī)信心。

Q3: In resource-limited settings, how can companies prioritize E&L testing without compromising compliance?

在資源有限的環(huán)境中，公司如何優(yōu)先考慮E&L測試而不影響合規(guī)性？

A3: In environments where resources are constrained, maintaining compliance with E&L testing can be particularly challenging, but not impossible. USP’s proposed system suitability standards are designed to be practical, reproducible, and globally applicable, helping laboratories of all sizes ensure their analytical systems are functioning correctly before screening begins. These standards offer a cost-effective way to verify method performance without the need for extensive in-house development.

在資源受限的環(huán)境中，保持對E&L測試的合規(guī)性確實(shí)具有挑戰(zhàn)性，但并非不可能。USP提出的系統(tǒng)適用性標(biāo)準(zhǔn)旨在實(shí)用、可重復(fù)并具有全球適用性，幫助各類規(guī)模的實(shí)驗(yàn)室在篩選開始前確保其分析系統(tǒng)正常運(yùn)作。這些標(biāo)準(zhǔn)提供了一種經(jīng)濟(jì)有效的方法來驗(yàn)證方法性能，而無需進(jìn)行廣泛的內(nèi)部開發(fā)。

Moreover, USP is expanding its suite of General Chapters to include targeted guidance for leachable assessments across a range of dosage forms—including oral, ophthalmic, parenteral, topical, and transdermal products. These upcoming chapters, along with associated analytical reference materials (ARMs), will provide scientifically validated tools and methods that can streamline testing and reduce the burden on individual labs to develop their own protocols from scratch.

此外，USP正在擴(kuò)展其一般章節(jié)，以涵蓋范圍廣泛的劑型——包括口服、眼用、注射、局部和透皮產(chǎn)品的浸出物評估，從而提供針對性指導(dǎo)。這些即將發(fā)布的章節(jié)以及相關(guān)的分析參考材料(ARMs)將提供科學(xué)驗(yàn)證的工具和方法，可以簡化測試過程，并減少單個(gè)實(shí)驗(yàn)室從頭開發(fā)其自身協(xié)議的負(fù)擔(dān)。

By leveraging USP’s standardized tools and evolving guidance, even resource-limited labs can uphold high standards of quality and compliance—ensuring patient safety without overextending operational capacity.

通過利用USP的標(biāo)準(zhǔn)化工具和不斷發(fā)展的指導(dǎo)，即使是資源有限的實(shí)驗(yàn)室也能保持高質(zhì)量和合規(guī)標(biāo)準(zhǔn)——從而在確?；颊甙踩耐瑫r(shí)，不會超出運(yùn)營能力。

Q4: How does the shift toward sustainable/biodegradable packaging materials complicate E&L profiling?

向可持續(xù)/可生物降解包裝材料的轉(zhuǎn)變?nèi)绾问笶&L分析復(fù)雜化？

A4: The transition to sustainable and biodegradable packaging materials introduces a new layer of complexity to extractables and leachables (E&L) profiling. While adoption in the pharmaceutical and biopharmaceutical sectors is still limited, the momentum is growing driven by environmental responsibility and regulatory encouragement. However, these novel materials often have less well-characterized chemical compositions and degradation pathways compared to traditional polymers.

向可持續(xù)和可生物降解包裝材料的過渡為提取物和浸出物（E&L）分析引入了新的復(fù)雜層次。盡管在制藥和生物制藥領(lǐng)域的應(yīng)用仍然有限，但隨著環(huán)境責(zé)任和監(jiān)管鼓勵的推動，這一趨勢正在增長。然而，與傳統(tǒng)聚合物相比，這些新型材料往往具有較少的已知化學(xué)成分和降解途徑。

This lack of historical data and standardized testing protocols makes it challenging to predict and assess potential leachables, especially under various storage and stress conditions. As these materials become more prevalent, the industry will need to develop new analytical strategies and expand existing guidance to ensure patient safety is not compromised.

缺乏歷史數(shù)據(jù)和標(biāo)準(zhǔn)化測試協(xié)議使得在各種儲存和應(yīng)力條件下預(yù)測和評估潛在的浸出物變得具有挑戰(zhàn)性。隨著這些材料的日益普及，行業(yè)將需要開發(fā)新的分析策略并擴(kuò)展現(xiàn)有的指導(dǎo)方針，以確保不損害患者安全。

In essence, the push for sustainability must be matched with scientific rigor—requiring proactive research, method development, and regulatory collaboration to ensure that greener packaging doesn’t come at the cost of product integrity or patient safety.

本質(zhì)上，可持續(xù)發(fā)展的推動必須與科學(xué)嚴(yán)謹(jǐn)性相匹配——這需要積極的研究、方法開發(fā)和法規(guī)協(xié)作，以確保環(huán)保包裝不會以產(chǎn)品完整性或患者安全為代價(jià)。

Q5: If you could propose one industry-wide initiative to tackle E&L challenges, what would it be?

如果您可以提出一項(xiàng)行業(yè)范圍的倡議來應(yīng)對E&L挑戰(zhàn)，那會是什么？

A5: If there were one initiative to unify and elevate the industry’s approach to E&L testing, it would be the global adoption of standardized system suitability protocols for extractables and leachables analysis. The greatest challenge facing the pharmaceutical and biotech sectors today is the generation of consistent, reproducible, and scientifically defensible E&L data across diverse labs, instruments, and methodologies.

如果要統(tǒng)一和提升整個(gè)行業(yè)對于E&L測試的方式，我會推進(jìn)全球采納標(biāo)準(zhǔn)化系統(tǒng)適用性方案，用于提取物和浸出物分析。當(dāng)今制藥和生物技術(shù)領(lǐng)域面臨的最大挑戰(zhàn)是在不同實(shí)驗(yàn)室、儀器和方法中生成一致、可重復(fù)和科學(xué)上可辯護(hù)的E&L數(shù)據(jù)。

Recognizing this, USP has invested over four years—guided by extensive stakeholder engagement and rigorous scientific evaluation—to develop comprehensive system suitability standards for GC-MS and LC-MS methods. This initiative is not just about instrument suitability,  it’s about building a foundation of trust in the data that drives regulatory decisions and protects patient safety.

為此，USP投入了四年多的時(shí)間——在廣泛的利益相關(guān)者參與和嚴(yán)格的科學(xué)評估指導(dǎo)下，發(fā)展了適用于GC-MS和LC-MS方法的綜合系統(tǒng)適用性標(biāo)準(zhǔn)。這項(xiàng)倡議不僅關(guān)乎儀器的適合性，更在于建立對驅(qū)動監(jiān)管決策和保護(hù)患者安全的數(shù)據(jù)的信任基礎(chǔ)。

A harmonized, industry-wide commitment to system suitability would transform E&L testing from a fragmented practice into a globally aligned, quality-driven discipline—ensuring that no matter where or how testing is performed, the results are reliable, reproducible, and regulatory-ready.

一個(gè)統(tǒng)一、行業(yè)范圍內(nèi)對系統(tǒng)適用性的承諾將把E&L測試從一個(gè)零散的實(shí)踐轉(zhuǎn)變?yōu)槿蛞恢?、質(zhì)量驅(qū)動的學(xué)科——確保無論測試在何地或如何進(jìn)行，結(jié)果都是可靠、可重復(fù)且符合監(jiān)管要求的。