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出自识林

2015-01-10 FDA

FDA药品审评与研究中心制药科学办公室代理主任余煊强博士，讨论了FDA和制药企业在保证药品质量中的重要作用。

药品质量 – 共同的责任

消费者期望并值得获得安全、有效、高品质的药品。这取决于FDA和制造商共同确保药品质量。FDA的工作是制定标准，执行上市前审评和检查，实施上市后监测和调查，以保障所有美国上市药品的安全、有效和质量合格。制药企业有责任满足这些标准以确保患者能获得高品质的产品。

药品质量的失败使患者承担不必要的风险。当生产设施发现质量问题时，可能引起产品召回和工厂停产，往往导致药品短缺。到目前为止，药品短缺最常见的原因（大约65%）与生产和质量问题相关。这些质量问题主要发生在无菌注射剂，其范围从灭菌问题到产品被玻璃、金属或其它物料颗粒污染。

然而，在过去十年间，随着FDA和ICH在过程分析技术、药物研发、质量风险管理和药品质量体系方面指南的发布和采纳，我们看到了药品生产质量的进步。同时，我们也看到药品制造业不断增长的矛盾。目前工业界已经逐渐接受在产品开发和质量系统方面的新技术和改善。尽管如此，美国公众正在面临着前所未有的药品短缺和召回。工业界和FDA有共同的义务减少质量错误，为美国公众提供高品质的药品。

为履行这一责任，工业界和FDA需要质量文化。真正的质量文化是一种环境，在这种环境中整个机构不仅能遵守质量准则，还能集中注意力于持续改进。重要的是，要认识到经济激励并不总能减少错误。员工必须对减少出错富有激情，并将做好质量作为他们的驱动力。

进一步努力：CDER新的办公室专注于质量

无论患者在哪里购买产品，也不管这些药品是非处方药、处方药、创新药、仿制药或者由传统配药房或传统制造商生产的产品，患者都应有权获得优质药品。质量是保障药品疗效的基石，应作为监管者和制造商在药品生命周期的每一步中的重要考虑因素。

这些年，我一直在观察着制药行业的成长和改变。多年来，FDA从调整组织机构的角度积极应对日益复杂的行业和产品。将于2015年1月成立的药品质量办公室（OPQ），是针对不断变化的行业环境下健全质量监管计划需求的回应。OPQ计划成为药品质量监管的全球标杆。

OPQ将通过简化现在由CDER多个部分监管的药品质量工作，提供整个产品生命周期的无缝评估和监控，以努力达到FDA 21世纪质量倡议规划的目标。新办公室将紧密整合审评、检查、监测、政策和研究工作，努力在药品质量方面提供统一的观点。

作为CDER高度关注质量的一部分，OPQ将致力于在上市前审评和上市后监测方面平衡监管资源，将产品质量监管从定性转变为定量的以专业知识为基础的过程。OPQ将在监管审评、监测和检查中采用基于风险的方法，最大限度的利用时间、精力和资源。我们的目标是对原料药、制剂和设施提供一致的质量建议。

主动监管提升质量

我们发现仅靠制造商的临时处理是不够的，因为质量问题往往反映的是更广泛、组织范围的质量问题。当制药企业拥有稳健的质量监管计划时，我们看到其产品具有较少的质量问题。因此，我们的新的更加主动的监管将帮助我们迅速找出问题，并在问题加剧之前积极采取措施。

如上所述，我们正在努力建立基于风险的方法，更加迅速地查明质量问题，使得我们在这些问题升级为重大系统问题之前迅速做出反映。我们将使用绩效指标帮助我们了解设施和产品的当前质量状态。根据这些信息，如果一家企业显示出无法达到质量标准时，我们能更好地决定何时实施监测或采取监管行动。

致力于帮助保证患者安全

最后，依赖药品和遭受质量差的后果的是患者，这令人深感不安。为患者提供不合格的或被污染的药品是无法原谅的。作为监管者，我通过培养专注于质量的企业和制定法规，致力于帮助保证患者免受不必要的风险。这是患者应得的。

余煊强博士于1999年加入FDA作为CDER制药科学办公室（OPS）药品质量研究处的领导者，后晋升为仿制药办公室副主任。他目前担任OPS代理主任，密歇根大学制药工程系兼职教授，AAPS杂志副主编。余博士获得浙江理工大学化学工程学士学位；浙江大学化学工程硕士学位；密歇根大学药剂学博士学位。加入FDA之前，余博士曾在葛兰素和辉瑞（法玛西亚普强公司）工作。

翻译：识林-椒 2015-01-10

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From our perspective: Patients deserve quality medications

Lawrence X. Yu, Ph.D., Acting Director of FDA's Center for Drug Evaluation and Research's Office of Pharmaceutical Science, discusses the important roles of FDA and drug companies in ensuring quality drug products.

Drug quality -- a shared responsibility

Consumers expect and deserve access to safe, effective, high-quality drugs and it’s up to both the FDA and manufacturers to make sure that they are available. It is FDA’s job to establish standards, conduct pre-marketing reviews and inspections, and perform post-marketing surveillance and investigations to safeguard that all U.S. marketed drugs are safe, effective and of adequate quality. Drug companies have a responsibility to meet these standards to ensure that quality products reach patients.

One quality voice

Failures in drug quality put patients at unnecessary risk. When quality issues arise in manufacturing facilities, product recalls and plant shutdowns can follow, often resulting in drug shortages. By far, the most frequently cited reasons – approximately 65 percent – for drug shortages relate to manufacturing and quality issues. These quality issues mainly occurred in sterile injectable drug products and range from sterility problems to products contaminated with particles of glass, metal or other materials.

However, in the past decade, we have seen progress toward quality pharmaceutical manufacturing through the issuance and adoption of FDA and International Conference on Harmonisation guidances on Process Analytical Technology, Pharmaceutical Development, Quality Risk Management, and Pharmaceutical Quality Systems. Still, we see a growing dichotomy in pharmaceutical manufacturing. There has been gradual acceptance of new technologies and enhancements in both product development and quality systems. Nevertheless, the American public is facing unprecedented drug shortages and recalls. Industry and the FDA have the shared obligation to reduce quality errors and provide high quality medications to the American public.

To fulfill this responsibility, both industry and the FDA need a culture of quality. A true quality culture is an environment in which the entire organization not only follows quality guidelines but also is focused on continuous improvement. It is important to recognize that financial incentives don't always reduce errors. Employees must be passionate about eliminating mistakes and making quality their driving principle.

Stepping up our efforts: A new office at CDER focused exclusively on quality

Patients should have access to quality medicines no matter where they purchase the product and regardless of whether the medications are non-prescription, prescription, brand name, generic, or if they were produced by a traditional compounding pharmacy or a conventional manufacturer. Quality is the foundation for assuring drug performance and should be a key consideration for both regulators and manufacturers at every step of the drug lifecycle.

I have been watching the pharmaceutical industry grow and change for many years. And over the years we at FDA have adapted our organizational perspective to proactively deal with the increasing complexity of the industry and its products. The Office of Pharmaceutical Quality (OPQ), due to “stand-up” in January 2015, is one response to the need for a robust regulatory quality oversight program in a changing industrial environment. OPQ intends to be a global benchmark for regulation of pharmaceutical quality.

OPQ will strive to achieve the goals laid out in FDA's 21st Century Quality Initiative by streamlining the drug quality work that is currently being done in multiple parts of our center to provide seamless assessment and surveillance over the product lifecycle. This new office will closely integrate review, inspection, surveillance, policy, and research in an effort to provide one unified view on pharmaceutical quality.

As part of CDER's heightened focus on quality, OPQ will work to balance regulatory resources between pre-marketing evaluation and post-marketing surveillance, and transform product quality oversight from a qualitative to a quantitative and expertise-based process. OPQ will employ risk-based approaches in our regulatory evaluation, surveillance, and inspection to maximize economy of time, effort, and resources. We aim to provide aligned quality recommendations that are inclusive of drug substance, drug product, manufacturing, and facilities.

Proactive Approach Aids Quality

We have found that temporary fixes by manufacturers are not enough because quality issues often reflect broader, organization-wide quality problems. When a drug company has a robust quality oversight program, we see far fewer quality issues with its drugs. However, our new, more proactive approach will help us identify a problem quickly and take prompt action before it can escalate. As mentioned above, we are working to establish risk-based measurements that identify quality issues more rapidly and enable us to respond quickly before they become major, systemic problems. We will use performance measures to help us know the current state of quality of both facilities and products. With this information, we can make better decisions on when to conduct surveillance or take regulatory action if a company demonstrates a pattern of being unable to achieve quality standards.

Committed to Helping Keep Patients Safe

At the end of the day, it’s the patients who rely on their medications and who suffer the consequences of poor quality; I find that deeply troubling. Providing patients with substandard or contaminated medications is simply unacceptable. As a regulator, I’m committed to helping to keep patients safe from unnecessary risk by fostering a quality-focused industry and regulations. Patients deserve it.

Dr. Lawrence X. Yu joined FDA in 1999 as a team leader in CDER's Office of Pharmaceutical Science’s (OPS) Division of Product Quality Research, and was later promoted to deputy director in the Office of Generic Drugs. He currently serves as Acting Director, OPS, adjunct Professor of Pharmaceutical Engineering at the University of Michigan, and Associate Editor of AAPS J. Dr. Yu received a B.S. in Chemical Engineering from Zhejiang Institute of Technology, China; M.S. in Chemical Engineering from Zhejiang University, China; M.S. in Pharmaceutics, University of Cincinnati; and a Ph.D. in Pharmaceutics, University of Michigan. Before joining FDA, Dr. Yu worked at both Glaxo and Pfizer (Pharmacia & Upjohn).