药明康德如何能始终做到高质量交付？他说“真金就要经得起千锤百炼” | 逐梦者说 | Bilingual

编者按：“让天下没有难做的药，难治的病”，是初心，更是愿景。自成立以来，药明康德步履不停：从一间实验室，到覆盖亚洲、欧洲和北美的全球网络。从早期的化学合成服务，到贯穿研究（R）、开发（D）和生产（M）的一体化平台。从第一位客户，到全球三十多个国家的数千合作伙伴。不断发展的，是规模与能力；始终坚守的，是梦想与承诺。

致敬来时路，共谱新篇章！在这一系列访谈中，我们以“逐梦者”视角，回顾药明康德成长发展的峥嵘岁月，回望赋能客户创新的并肩往事，更以独特的“药明精神”展望未来新篇章。

每到周末，当邮件减少，办公室灯光渐暗，德克·托曼斯（Dirk Tormans）常会寻一处静谧之地独自散步。

不管是走在蜿蜒的公园小径里，还是走在开阔的河畔步道上，对他来说既是难得的放松方式，也是换一种心情思考问题的宝贵机会。

经常是走着走着，萦绕在心中的问题就会迎刃而解，对未来的各种设想也涌上心头。

不散步的时候，德克会在电脑上玩策略游戏。他坦诚地笑了笑说，这个爱好在很多方面都与他在工作中秉持的理念不谋而合——两者都需要总览全局、关注细节、预判风险、见招拆招、有勇有谋地采取行动，并从经验中不断学习。

回望德克30年来的职业生涯，他的工作内容基本离不开这九个字——质量管理与质量控制。

在医药行业，质量尤其具有不可撼动的地位，既是企业长远稳健发展的根基，更是关乎患者健康安全的“生命线”。

而“高质量交付”之所以能成为药明康德的一张名片，背后是药明康德质量管理团队对上述工作理念长年累月的传承与坚守，以及由此打造出的一套高标准、成熟庞大并不断完善的质量体系。

图片来源：123RF

自成立以来，这套坚实的质量体系已深深根植于药明康德全球各个基地的土壤之中，守护着世界各地数千家创新者的新疗法从萌芽到开花结果、来到患者身边。

每一天，高标准已成习惯

作为药明康德化学业务平台全球质量保证（QA）负责人，用德克自己的话说，他的角色“就像是质量的推动者”。

他经常向团队强调的一句话是，质量管理不能只在有人监督时才去执行，不能因为会有检查才去准备，而是要自发融入每一天的日常工作习惯。

谈到这一点，他回想起了药明康德在去年经历的一次检查。

那是一个早晨，在没有事先通知、毫无准备时间的情况下，美国食品药品监督管理局（FDA）的检查人员突然造访了药明康德的一家生产基地，并开始了质量审查。

在业内，这种不预先告知的突击检查方式被称为“飞行检查”（简称“飞检”），是监管机构为确保药品在研制、生产、经营、使用等环节符合质量管理规范的常见做法，从而保障药品质量、保护公众健康。

在检查过程中，当地团队并没有暂停手头的任务，也没有为了应对检查临时进行特别的调整，而是一如既往地按照既定流程工作着。

之后，检查顺利结束，FDA未发现任何不符合项。这验证了一个事实——药明康德能顺利地通过检查，不是靠“临阵磨枪”的准备就能做到的，而是因为每一天的日常工作都经得起检验。

以往的记录也证明了这一点。仅在2024年，药明康德就接受了各类质量审计共计802次，包括69次来自监管机构的审计、719次来自全球客户的审计，以及14次来自独立第三方的审计；就在2025年3月，常州及泰兴的两个原料药基地相继成功通过美国FDA检查。

回望药明康德的来时路，你会发现，从创立伊始，药明康德就严格遵循来自客户和监管部门的高标准、严要求，通过了来自美国、欧盟、中国、日本、瑞士、澳大利亚、加拿大、新西兰等国家地区监管机构的数百次审计。

在德克看来，这些“零缺陷”、“全通过”的记录，不是靠“救火队员”的力挽狂澜，而是靠每一个成员都将高标准、严要求铭记在心，将这个习惯渗透到投料控制、实验记录保存、偏差处理等日常操作的方方面面。

以药明康德的化学业务为例，从原料的资质认证、供应商管理，到生产执行、设备校验，再到分析验证、包装、存储和运输全流程，公司早已建立起了一个系统化、结构化的质量体系。

德克指出，这个质量体系之所以能不断完善，不只是靠QA团队对流程的推动，更依赖于各业务团队每一位同事的智慧与汗水。

他经常向大家强调，“全员都是质量的责任人，为保障患者的安全，从高层管理人员到每一个执行环节的同事，都要共同遵守质量体系、共同守护对客户的质量承诺”。

图片来源：123RF

德克还特别提到了一点：自成立以来，药明康德从来没有因质量问题经历过一次重大监管投诉或执法行动，也没有卷入过一次召回事件。

说到这里，德克百感交集，因为他深知要做到这样有多难，更清楚失守的危害有多大——一旦出现质量问题，就可能造成药品供应中断或短缺，最终受到冲击的还是患者。

尤其对于一些重症患者而言，失去了一款为数不多的有效药物，就可能失去了延续生命的机会。

在这一背景下，药明康德自成立以来，始终保持着良好的记录，既是对技术与诚信兼顾并重的自我约束，更是对患者生命健康的珍视与守护。

每一个基地，高质量始终如一

德克表示，药明康德为客户提供高质量服务的承诺，不仅仅是时间上的“每天始终如一”，还在于空间上的“每个基地都始终如一”。

自成立以来，为了更好地为当地和全球客户提供灵活、高效和高质量的赋能服务，药明康德的全球发展足迹跨越亚洲、欧洲和北美，建立起了20多个研发和生产基地，涵盖新药研究（R）、开发（D）和生产（M）的各个环节。

很多人会问，这么多的全球基地，人员跨越国界、跨越不同时区与文化，质量管理能统一吗？

这也是德克和他的团队一直在做的事情。他们的工作任务之一，就是为公司的化学业务平台建立全球统一的质量体系，并担负起各基地之间“桥梁”的角色。

他们要确保无论在哪个基地，质量标准都能保持高度一致，并能在工作中有效实施，既能符合全球监管机构的法规和要求，也能满足全球客户的需求。

德克坦言，为实现这一目标，在计算机和网络技术不甚发达的时期，团队曾经非常依赖纸质文档。

而如今，公司早已建立了全球化的信息技术系统，每一个实验记录、检验与合规记录等都纳入了严密的内部信息管理系统，包含严格的权限管控、完善的审计追踪功能与信息安全防护，各基地人员可以高效地查阅权限范围内与自己业务相关的决策与文件。它推动了全球各个基地使用同一套“质量术语”，减少了理解和执行上的分歧，也避免了很多中间环节与重复工作，同时也是强化数字与知识产权（IP）保护的“护城河”。

德克设想，未来或许还会有更高效的系统来管理信息、并进行预测分析，以及统一的系统来实现流程实时监控甚至实时发布，这是行业的大趋势。

略作沉思之后，他又谈到更深一层的感悟：“技术升级、打通信息系统固然重要，但背后始终要有人的参与”。

用他的话说，这叫做“让知识跟着人流动起来”。

首先是自上而下的统一培训。他的团队会根据需要请各业务领域专家制定并更新相关流程，流程一经批准，就会在公司内部开展标准化培训，确保所有参与的人员都训练有素、对齐标准。

其次是同事之间的相互学习交流。新基地投产前，新的QA负责人会前往其他基地“取经”；其他基地的QA负责人以及有经验的团队成员也会出差前往新基地，协助当地“复制”规范与经验。以公司正在建设的美国米德尔顿基地为例，拟任当地QA负责人的同事曾到中国其他基地“取经”数周，这样明年年底启动运营后就能快速开展工作。

“要让客户在不同基地体验到始终如一的优质服务”，这种精神也得到了客户高度一致的认可。

不少客户会使用药明康德多个基地的服务，他们常常会给德克这样的反馈：“感觉一切都整合得非常好”。

不止于“做对、做好”，而是“做得更好”

在德克看来，这套高标准、严要求的质量体系，也是公司质量文化的体现，它源于一条深深刻在药明康德基因里的价值观——“做对的事，把事做好”。

而且在公司的质量文化中，不止满足于“把事做好”，还会鼓励大家不断思考“如何做得更好”。

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在质量团队的工作中，如何才能做到更好呢？

德克给出了一个简洁而又令人深思的答案：要保持积极、开放的态度。

他表示，大家理想中的状态是万无一失。但现实的情况是，事前规划、准备得再好，也难免会有意想不到的问题出现。

面对这些问题，一味地掩盖或抱怨并不能让人成长，更重要的是开诚布公地拿出来积极讨论，发现问题、解决问题。

当然，保持开放的态度并不意味着问题可以改了又犯，这会严重影响成本与速度。要吸取教训、杜绝类似的事情再次发生。

首先，“开放”体现在对待客户审计的态度上。

每年数百次的客户审计，德克与他的团队每一次都以非常积极、开放、透明的态度去面对，从来不会将其视为“负担”、或是带有“如临大敌”的疏远回避心态。

在外人看来，这是“真金不怕火炼”，是对公司质量体系信心十足的体现；而在他们眼中，“真金就要经得起千锤百炼”，这恰恰是一个让公司质量体系从不同视角接受检验的机会。

当客户提出一些小建议时，团队总是会认真地对待，或是为其提供合理的解释与说明，或是与业务同事一起思考如何真正改进、做好风险预警。

每一处提升质量的细微改进，也如同恰到好处的炼金之火，日积月累，将质量体系锤炼得越发精细、完善。

这一点也深受客户赞赏。客户们在审计完成后常常会表示“药明康德的质量体系非常成熟”，并对质量体系的执行充满信心。

其次，“开放”还体现在公司内部的沟通上。

有时不同业务团队会发生意见不一致的情况，比如测试同一个产品时，结果却有所不同，双方就会开始各抒己见。

遇到这样的情况，德克与他的团队会鼓励大家倾听并尊重彼此的观点，共同找到更好的解决方案，并把问题写进培训案例，让不同基地的同事一起学习，合作共赢。

在QA团队内部，德克也常常强调开放与合作的重要性：“不要认为你们是某个基地的QA团队、他们又是另一个基地的QA团队。要记住，我们是同一个QA团队，每个人都要相互支持。”

正如中文“人”字的写法——两笔相互支撑，才能形成一个稳定的结构。

而三“人”成“众”的稳定，来自每一个人都朝着同一个方向的勇往直前。

这个共同的方向，是药明康德“让天下没有难做的药，难治的病”的愿景。

如果说药明康德是护送新药到达治疗疾病彼岸的航船，其质量体系就是船上每一根牢固的钉，每一块坚实的板。

历经26年风浪，它们穿越时间，成了药明康德坚守不变的厚重积淀，行稳方能致远。

Building Systems That Protect Patients Around the World

Editor’s Note: “Every drug can be made and every disease can be treated”. Since 2000, from a single laboratory to a global network spanning Asia, Europe, and North America; from early chemical synthesis services to an integrated platform that connects Research (R), Development (D), and Manufacturing (M); from its very first customer to thousands of partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision.

In tribute to the journey, we look back through the eyes of our “dream-makers”: revisiting the stories of partnership that empowered global innovation, and the unique spirit that continues to guide us toward the next chapter.

On weekends, when the emails slow and the lights dim in the office, you might find Dirk Tormans doing something unhurried: walking. Long stretches of trails and quiet city paths give him time to reflect, to unwind, to think several steps ahead. And when he is not walking, he immerses himself in strategy games. He smiles when he explains this hobby, and it makes perfect sense. Strategy games require planning, discipline, anticipation, and the willingness to learn from experience. In many ways, they echo the mindset that guides his work.

Over the past three decades, that mindset has shaped a quality system that supports innovators around the world as they develop new medicines, advance regulatory submissions, and move therapies from discovery to patients. It is a system defined not only by compliance, but by consistency, transparency, trust, and shared purpose.

A System Built to Be Inspection-Ready, Every Day

When a regulatory authority or a client walks into a WuXi AppTec site, the system they encounter is not assembled for a single audit; it is designed for daily execution. This principle has shaped the company’s approach to quality under the leadership of Dirk, Head of QA, who describes his role as less about directing and more about facilitating a system in which quality is part of how people work every day. He often notes thatquality cannot be something performed only when someone is watching; it must be embedded in routine practice, in how records are kept, how deviations are handled, and how teams understand procedures, and the reasons behind them.

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This philosophy was evident during a recent unannounced FDA inspection, a common practice to ensure GMP quality, at one of WuXi AppTec’s manufacturing sites. Investigators arrived without prior notification and began their review. The teams did not need to adjust or prepare; they continued operating under their established systems. The inspection concluded with no observations. For Dirk, the significance was not the result itself, but what it confirmed:a system in which readiness is the everyday state, not a special event.

The foundation for this readiness is a structured quality framework that spans the full arc of pharmaceutical manufacturing: from raw-material qualification and supplier oversight, through production execution and equipment calibration, to analytical verification, packaging, storage, and shipment. Dirk emphasizes that this framework is strengthened by people, not just procedures.He frequently points to the dedication of site teams, describing quality as “a total company responsibility,” upheld through collaboration and shared accountability.

In more than two decades of global operations, this framework has been examined in hundreds of regulatory inspections across agencies worldwide. During this period, WuXi AppTec reports no critical regulatory findings, no enforcement actions, and no product recalls. In a landscape where a single recall can disrupt patient access to essential therapies, this sustained history reflects not only technical rigor, but the shared commitment of thousands of people to protect patient safety.

One Global Quality System, Consistency Across Continents

As WuXi AppTec’s platform has expanded across regions and time zones, Dirk has focused on ensuring that quality feels familiar wherever work is done. This effort, years in the making, began with global growth in mind and centered on a practical aim:people at different sites should follow comparable ways of working and understand why those practices matter. This approach led to the One Global Quality System, a unified framework that aligns expectations across locations.

A key step in making this possible was transitioning from paper-based processes to global computerized systems. This shift did more than digitize records; it allowed decisions and quality documentation to be interpreted consistently across the network. It helped sites speak the same “quality language,” reduced ambiguity, and supported oversight without duplication.

Within this framework are global quality procedures: standardized GMP and best-practice requirements co-developed by subject-matter experts across the network. Once approved, these procedures are implemented through standardized training, ensuring that teams understand not only what to do, but how their work will be evaluated across the organization.

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The integration of the Couvet, Switzerland, manufacturing site demonstrates how the One Global Quality System is implemented. Rather than building a new local system, Couvet is connected to the established global framework; adopting the same global quality procedures, computerized systems, and standardized training used across the network. QA leaders from other sites spent time in Couvet to understand routines, explain expectations, and map local processes to the global framework. Subsequent inspections by Swissmedic, the FDA, and Brazil’s ANVISA proceeded without interrupting production, indicating that the site had fully aligned to the global system as intended.

The same approach guides newer sites in Middletown, Delaware, and Singapore. Dirk notes that leaders are being embedded early, and quality systems are established before operations begin. In Dirk’s words,the work is about “building bridges” among sites so that knowledge moves with people and questions are resolved consistently and transparently.Consistency, in his view, is not identical facilities; it is a shared standard, supported by common systems, procedures, and training, that allows work to be understood and improved across the network.

Dirk confirms that clients repeatedly validate the impact of this approach. “Very often I get feedback that they experience a consistent quality of service across the sites,” he says. In practice, that consistency saves time and costs: for example, a qualification audit at an API site often lets them limit audit time at a downstream drug-product site because the procedures, computerized systems, and training are the same.

Quality Culture: the Human Foundation that Creates Client Experience

Yet the strongest systems in the world cannot function without the right culture. For Dirk, culture is where quality truly lives.He believes that WuXi AppTec’s quality culture aligns with its simple, but meaningful principle: “Doing the right thing; Doing it right.”Doing the right thing reflects intent: acting in the interest of patient safety and scientific integrity. Doing it right speaks to discipline: carrying out the work with rigor and clarity, so that decisions stand up to scrutiny.

This mindset shapes daily actions.Quality is not the responsibility of one department; it is the responsibility of everyone.This shared ownership means deviations are not hidden or minimized but openly examined.Mistakes are treated not as failures to be punished, but as opportunities to understand, learn, and prevent recurrence.Teams support each other across functions and sites when challenges arise, reflecting a belief that success and improvement belong to the whole organization.

Clients also experience this culture during their own audits. WuXi AppTec hosts hundreds of client audits each year, and the tone is consistent: transparent, welcoming, collaborative.Instead of treating audits as disruptions, teams treat them as opportunities to strengthen the system, demonstrate confidence in practice, and learn from external perspectives.

Clients frequently describe the experience as reassuring: not because everything is perfect, but because the organization approaches both strengths and challenges with maturity and openness.As Dirk explains, clients consistently share the same takeaway after an audit: The quality system is very mature, and they feel very confident in how it is executed. They may offer recommendations, and these are always welcomed. What clients see in the closeout discussions is a commitment to take every observation seriously, evaluate it carefully, and use it to drive continuous improvement.

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For many emerging biotechnology companies, WuXi AppTec’s quality infrastructure becomes more than a service. It serves as a cornerstone of regulatory credibility, an enabler of INDs and marketing submissions, and ultimately, a safeguard for the patients they hope to reach.

Looking Ahead, Preparing for the Next Era

The future of quality assurance is evolving. Advanced therapeutic modalities will demand deeper integration between analytical development and manufacturing control. Regulatory oversight is shifting toward real-time evaluation, continuous monitoring, and data-driven assessment of quality maturity. Predictive analytics, digital batch records, and eventually real-time release will reshape how manufacturing and quality teams interact.

Dirk is preparing for that future now: strengthening infrastructure, developing cross-site leadership, and ensuring that every new site is not just compliant, but capable of sustaining excellence from Day One.

When asked what WuXi AppTec’s vision — “Every drug can be made and every disease can be treated” — means to him, Dirk answers with quiet clarity:

“It means we work hard every day to make sure patients can receive high quality and new medicines they need.”

And then, when the workday ends, he walks again, steady, thoughtful, and deliberate. Because quality is not a destination. It is a journey. And Dirk is still walking it.

免责声明：本文 仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗 方案指导，请前往正规医院就诊。

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