FDA质量管理成熟度

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请帮忙找一下，2023年FDA发布的CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development的翻译版。

胜利者

CDER is developing a prototype assessment protocol covering five practice areas:
CDER正在开发一个涵盖五个实践领域的原型评估方案：

1. Management Commitment to Quality
1. 管理层对质量的承诺
2. Business Continuity
2. 业务连续性
3. Advanced Pharmaceutical Quality System (PQS)
3. 先进的药品质量体系（PQS）
4. Technical Excellence
4.卓越的技术
5. Employee Engagement and Empowerment
5. 员工敬业度和授权

胜利者

These practice areas were identified through a comprehensive review process. This process involved examining the literature on quality management including existing programs that evaluate elements of quality culture or pharmaceutical quality, surveying external stakeholders, gathering feedback from partner offices and centers within FDA, and evaluating data from the two QMM pilot programs developed and performed by third-party contractors, in addition to feedback from pilot participants. By conducting a survey of similar initiatives undertaken by external stakeholders,8 we gained valuable insights into the content of the practice areas and the scientific aspects of performance measurement. CDER also collaborated closely with our FDA partners to understand quality performance trends and learn from their experiences with similar efforts.9 The QMM pilot programs provided insight into the process of the assessment and best practices for engaging with participants. Additionally, we reviewed case studies based on the development and implementation of ICH Q9(R1), ICH Q10, and ICH Q12, as well as industry standards (e.g., ISO 9000 Series of Standards).10
这些实践领域是通过全面的审评过程确定的。该过程涉及检索质量管理的文献（包括评估质量文化或药品质量要素的现有计划），调查外部利益相关者，收集FDA内部合作办公室和中心的反馈，以及评估第三方合同商建立和执行的两个QMM试点项目的数据和试点参与者的反馈。通过对外部利益相关者采取的类似举措进行调查，8我们获得了关于实践领域的内容和绩效衡量的科学方面的宝贵见解。CDER还与FDA合作伙伴密切合作，以了解质量绩效趋势，并从他们的类似工作经验中学习。9 QMM试点项目提供了对评估过程以及与参与者互动的最佳实践的深入了解。此外，我们基于ICH Q9(R1)、ICH Q10 和 ICH Q12 的开发和实施以及行业标准（例如，ISO 9000 系列标准），对案例研究进行了回顾。10

The following section describes each practice area, provides examples of elements considered in an assessment, and explains why each practice area is important to QMM.
下文对每个实践领域进行了描述，提供了评估中考虑的要素的示例，并解释了为什么每个实践领域对 QMM 而言是重要的。

1. Management Commitment to Quality
1. 管理层对质量的承诺
The commitment of all levels of management is necessary to establish a company-wide commitment to quality. Leadership plays a crucial role in ensuring the quality, safety, purity, and identity of drugs delivered to patients and consumers. Management bears the responsibility for setting the tone and modeling a culture of quality within the organization. Management is responsible for establishing the quality policy and objectives, ensuring that these objectives are prioritized, and aligning them with the business objectives and strategic plan. Management is also responsible for allocating the necessary resources to support quality objectives and continual improvement activities. Effective communication is vital to fostering a commitment to quality. Managers play a central role in facilitating clear and open communication channels throughout the organization.
各级管理层的承诺对于建立全公司范围的质量承诺是必要的。领导层在确保交付给患者和消费者的药品的质量、安全性、纯度和鉴别方面发挥着至关重要的作用。管理层有责任在组织内定下质量文化的基调，并树立榜样。管理层负责制定质量方针和目标，确保这些目标被优先考虑，并使它们与业务目标和战略计划保持一致。管理层还负责分配必要的资源以支持质量目标和持续改进活动。有效的沟通对于促进对质量的承诺至关重要。管理人员在推动整个组织的清晰和开放的沟通渠道方面发挥着核心作用。

Elements that may be reviewed under this practice area include how management prioritizes and establishes quality goals and policies, and how effectively these goals are communicated to staff at all levels in an organization. The assessment may also cover the effectiveness of management review, including how often they perform their review, to what depth they review data, and how they use the outputs of the review process to initiate continual improvements.
可在本实践领域审评的要素包括管理层如何优先考虑和制定质量目标和政策，以及如何有效地将这些目标传达给组织中的所有级别的员工。评估还可能涵盖管理层审查的有效性，包括审查的频率、审查数据的深度以及如何使用审查过程的结果来进行持续改进。

The management of less mature establishments may not align quality objectives with business objectives, and therefore may not allocate resources to quality improvement projects. Management may not ensure that their quality policy or goals are documented, or they may not communicate the quality policy or objectives to establishment personnel at all levels within an organization. By contrast, the management of more mature establishments will integrate quality into their business goals and strategic plans and ensure resources are made available to meet clearly defined quality goals that are known and understood by staff throughout their organization.
不太成熟的场地的管理层可能不会使质量目标与业务目标保持一致，因此可能不会为质量提升项目分配资源。管理层可能不会确保他们的质量方针或目标有文件记录，或者他们可能不会向组织内各级的场地人员传达质量方针或目标。相比之下，更成熟的场地的管理层会将质量整合到其业务目标和战略计划中，并确保提供资源以实现明确定义的质量目标，这些目标整个组织中的员工都知道并理解。

2. Business Continuity
2. 业务连续性
Business continuity ensures that business operations are sustained during expected or unexpected disruptions so that patients have access to a reliable supply of drug products. Successful development of business continuity plans can help establishments minimize economic losses by ensuring continuity of operations. Given the complexity and interdependencies in the pharmaceutical supply chain, it is essential to design operations and supply chains to safeguard against potential disruptive events, thus ensuring supply reliability. Building mature systems relies on effectively identifying hazards, analyzing and mitigating risks associated with those hazards, implementing good governance, and establishing robust monitoring programs. Such monitoring programs serve as early warning systems, enabling the rapid detection or prediction of disruptions to business operations.
业务连续性可确保在预期或意外中断期间维持业务运营，以便患者获得可靠的药品供应。业务连续性计划的成功制定可以通过确保运营的连续性来帮助场地最大限度地减少经济损失。鉴于药品供应链的复杂性和相互依赖性，需要设计运营和供应链以防止潜在的破坏性事件，从而确保供应可靠性。建立成熟的系统取决于有效地识别危害、分析和减轻与这些危害相关的风险、实施良好的管理以及建立稳健的监测计划。此类监测计划可作为早期预警系统，能够快速检测或预测业务运营的中断。

Elements that may be reviewed under this practice area include how effectively an establishment builds redundancies into its supply chains to continue operations even when there are sudden changes in the availability of raw materials or packaging materials. This is tied to how well an establishment understands and mitigates risks inherent to its supply chain (e.g., through the development of effective risk management plans). The assessment may also cover the effectiveness of an establishment's preventive maintenance program, how frequently they experience production disruptions because of unplanned maintenance to their facilities or equipment, and how quickly they can overcome these disruptions to ensure a steady supply of products.
可在本实践领域审评的要素包括，场地如何有效地在其供应链中建立冗余，从而即使在原料或包装材料的可用性发生突然变化的情况下，也可以继续运营。这与场地对其供应链固有风险的理解和缓解程度（例如，通过制定有效的风险管理计划）有关。评估还可能涵盖场地的预防性维护计划的有效性，由于设施或设备的计划外维护而导致生产中断的频率，以及他们能够以多快的速度克服这些中断以确保产品的稳定供应。

Less mature establishments may not thoroughly understand the complexities and risks inherent in their supply chains, and therefore, may develop limited risk mitigation strategies that may not be effective in managing unexpected disruptions. More mature establishments will have insight into the complexity and risks inherent in their supply chains, implement effective cybersecurity measures, develop effective risk management plans, forecast demand, qualify backup suppliers, and optimize inventory levels so that they can effectively respond to unexpected disruptions.
不太成熟的场地可能无法彻底了解其供应链中固有的复杂性和风险，因此可能制定有限的风险缓解策略，这些策略可能无法有效地管理意外中断。更成熟的场地能够洞察其供应链中固有的复杂性和风险，实施有效的网络安全措施，制定有效的风险管理计划，预测需求，确认后备供应商的资格并优化库存水平，以便能有效地应对意外中断。

3. Advanced PQS
3. 先进的PQS
Establishments implement practices and procedures to support and sustain robust quality systems consistent with CGMP to produce drug products that meet expected identity, strength, purity, and quality characteristics. An advanced PQS effectively uses quality principles (e.g., quality by design) and risk management approaches to ensure its continued suitability, capability, and reliability to minimize disruptions to drug production operations. Establishments that cultivate an advanced PQS benefit from gains in production efficiencies and improved process performance and product quality, which can lead to reduced costs and greater customer satisfaction. Enhancements to the PQS can also help to ensure a more reliable supply of quality drug products by minimizing the occurrence of quality-related failures that can provoke drug shortages.
场地实施规范和规程来支持和维持与CGMP一致的稳健的质量体系，以生产出符合预期鉴别、规格、纯度和质量特征的药品。先进的PQS有效地使用质量原则（例如，质量源于设计）和风险管理方法来确保其持续的适用性、能力和可靠性，以尽量减少药品生产运营的中断。建立先进PQS的场地受益于生产效率的增长以及工艺性能和产品质量的提升，这可以降低成本并提高客户满意度。对PQS的改进还可以通过尽量减少可能导致药品短缺的质量相关失败的发生，来帮助确保更可靠地供应高质量药品。

Elements that may be addressed under this practice area include the establishment's approach to quality risk management (QRM), the rationale for monitoring their process performance and product quality monitoring systems, understanding how the establishment leverages corrective actions and preventive actions (CAPAs) and information from process performance and product quality monitoring activities to improve their manufacturing operations, the rationale governing how a corrective or preventive action is determined to be effective, and the establishment's change management system's ability to effectively evaluate, approve, and implement changes properly.
本实践领域可能涉及的要素包括场地的质量风险管理（QRM）方法，工艺性能监测和产品质量监测系统的基本原理，了解场地如何利用纠正和预防措施（CAPA）以及来自工艺性能和产品质量监测活动的信息来改进生产操作，如何确定纠正或预防措施有效的基本原理，以及场地的变更管理系统有效地评估、批准和正确实施变更的能力。

An advanced PQS implements a systematic process for the assessment, control, communication, and review of risks to the quality and availability of the drug product across the product lifecycle. A proactive approach to QRM can minimize the occurrence of quality-related failures and is of foundational importance in achieving an effective PQS. Less mature organizations may invest in corrective actions in reaction to failures, but do not devote resources to preventive actions to mitigate potential failure modes. More mature establishments utilize QRM principles and leverage knowledge throughout the lifecycle to make informed and timely decisions, and proactively review risks at an appropriate frequency to drive continual improvement and ensure availability of drug products.
先进的PQS实施一个系统性的过程，以评估、控制、沟通和回顾整个产品生命周期中药品的质量和可用性的风险。积极主动的QRM方法可以最大限度地减少质量相关失败的发生，对于实现有效的PQS至关重要。不太成熟的组织可能会在纠正措施方面投入，以应对失败，但不会将资源用于预防措施以缓解潜在的失败模式。更成熟的场地利用QRM原则并利用整个生命周期内的知识做出明智且及时的决策，并以适当的频率主动回顾风险以推动持续改进并确保药品的可用性。

4. Technical Excellence
4. 卓越的技术
Technical excellence involves effectively managing information and data. This includes understanding the needs, capabilities, and limitations of operations, investing in learning, and adopting new technical skills. Technical excellence also includes implementing innovative manufacturing processes or novel solutions to problems impacting any aspect of the business (e.g., manufacturing, communications, accounting), and using advanced technologies that are fit for purpose. A commitment to technical excellence reflects a culture that proactively enhances the quality of pharmaceutical products, processes, and services while promoting operational excellence within the organization.
卓越的技术包括有效地管理信息和数据。这包括了解操作的需求、能力和局限性，在学习上投入，以及采用新的技术技能。卓越的技术还包括对影响业务任何方面（例如，生产，沟通，会计）的问题实施创新的生产工艺或新的解决方案，以及使用适合其目的的先进技术。对卓越技术的承诺反映了一种主动提高药品、工艺和服务质量的文化，同时促进组织内的卓越运营。

Elements that may be addressed under this practice area include how effectively an establishment manages information across their organization to ensure data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available to all who need it regardless of the format (e.g., paper-based system, electronic system). The assessment may also review how effective an establishment is at synthesizing information from different sources, determining a proposed solution (e.g., technological upgrade of equipment or software) is fit for purpose, and ensuring effective implementation of the solution to enhance business operations or production processes.
本实践领域可能涉及的要素包括，场地管理其组织中的信息的有效性如何，以确保数据可归属、清晰可辨、同步、原始、准确、完整、一致、持久，并且所有需要的人都可以使用，无论是什么格式（例如，纸质系统，电子系统）。评估还可以审查场地在以下方面的有效性：综合不同来源的信息，确定拟定的解决方案（例如，设备或软件的技术升级）符合其目的，以及确保解决方案的有效实施，以增强业务运营或生产工艺。

Less mature establishments may struggle with data integration, which limits their ability to perform holistic reviews, gain a better understanding of their business operations, and identify emerging hazards to quality. This limitation can hinder their ability to identify opportunities for optimizing production operations or business processes. In contrast, more mature organizations have effective methods or mechanisms in place to maximize the use of relevant data and sources of knowledge, enabling them to optimize both production and business operations. Even when financial resources are available, less mature establishments may be resistant to embracing unfamiliar changes (e.g., technological, procedural, conceptual) that could enhance their business operations. Yet more mature establishments are early adopters and are willing to evaluate and accept changes that have been vetted and add value to their operations while controlling any other risks that are introduced via the changes.
不太成熟的场地可能难以进行数据整合，这限制了他们进行全面回顾、更好地了解其业务运营以及识别新出现的质量危害的能力。这种限制会阻碍他们识别优化生产操作或业务流程的机会。相比之下，更成熟的组织拥有有效的方法或机制来最大限度地利用相关数据和知识来源，使他们能够优化生产和业务运营。即使有可用的财务资源，不太成熟的场地也可能不愿意接受可以增强其业务运营的不熟悉的变更（例如，技术，程序，概念）。然而，更成熟的场地是早期采用者，愿意评估和接受已经过审查的变更，并为其运营增加价值，同时控制变更带来的任何其它风险。

5. Employee Engagement and Empowerment
5. 员工敬业度和授权
Employee engagement refers to employees' motivation and commitment to positively impact an organization's quality policy and quality objectives. Engaged employees understand and care about how their roles within the organization impact patients and consumers, product quality, and product availability. Engaged employees at all levels take ownership and are empowered to identify, communicate, escalate, and initiate changes that continually improve processes, procedures, and practices.
员工敬业度是指员工对组织的质量方针和质量目标产生积极影响的动力和承诺。敬业的员工了解并关心他们在组织中的角色如何影响患者和消费者、产品质量和产品可用性。各级敬业的员工都拥有自主权，并能够识别、沟通、上报和发起变更，以持续改进工艺、规程和做法。

Elements that may be addressed under this practice area include how willing employees are to making suggestions that can improve business or manufacturing operations and whether leadership creates an environment that encourages employees to share their thoughts and ideas. The assessment would also gauge employees' understanding of the impact of their role on product quality and patient safety. Engaged employees will seek and have access to opportunities to grow their expertise and have clear career paths to grow within the organization.
本实践领域可能涉及的要素包括，员工提出建议以改进业务或生产运营的意愿如何，以及领导层是否创造了一种鼓励员工分享想法和观点的环境。评估还将衡量员工对其角色对产品质量和患者安全的影响的理解。敬业的员工将寻求并获得机会来提升他们的专业知识，并在组织内拥有清晰的职业发展道路。

Less mature organizations will miss out on opportunities to solicit feedback from employees and act upon their suggestions to improve quality systems and production processes. A workforce that is not engaged, empowered, and enthusiastic will struggle to continually complete routine duties in a reproducible manner with the highest standards, employee turnover may be high, and institutional knowledge may be lost as a result. Employees who do not understand the importance of their role in the organization and appreciate the responsibility they bear toward patients may not give their work the attention it needs. By contrast, more mature establishments will have effective methods to facilitate engagement with staff at all levels. Establishments that foster a culture of active participation without fear of reprisal can more effectively leverage the expertise, experience, and input of employees to drive continual improvement. Satisfied employees are more likely to go above and beyond the call of duty and stay with an organization, keeping institutional knowledge in-house. Employees who actively feel they are part of the organization will be more invested in their work and see it as an investment in themselves and the patients they serve.
不太成熟的组织将错过从员工处征求反馈意见，并根据他们的建议采取行动以改进质量体系和生产工艺的机会。不投入、不被授权且没有热情的员工队伍将难以根据最高标准以可重现的方式持续完成日常职责，员工流动率可能很高，机构知识可能因此而流失。不了解自己在组织中角色的重要性以及不了解他们对患者所承担的责任的员工，可能无法给予其工作所需的关注。相比之下，更成熟的场地将有有效的方法来促进各级员工的参与。场地建立积极参与而不用担心报复的文化，可以更有效地运用员工的专业知识，经验和意见来推动持续改进。满意的员工更有可能做到超越其职责范围，并更有可能留在组织中，将机构的知识保留在内部。积极地认为自己是组织的一部分的员工将更多地投入到他们的工作中，并将其视为对自己和所服务的患者的投入。

Addressing Possible Misconceptions About the QMM Program
解释关于 QMM 计划的可能误解
QMM assessments are not used to evaluate compliance with CGMP. CGMP requirements are foundational to any drug manufacturing operation. Compliance with CGMP is evaluated through surveillance inspections or other inspections conducted by credentialed investigators under section 704(a)11 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Inspections are mandatory and refusal to permit entry or inspection is prohibited under section 301(f)12 of the FD&C Act. In contrast, QMM assessments are not part of FDA's inspection authority and participation in the QMM program is voluntary. The QMM assessment cannot be used to determine compliance with CGMP. QMM assessments focus on evaluating the behaviors, practices, and quality culture within an establishment. Higher levels of QMM indicate a higher process capability and performance and a reduced risk of quality failures that can contribute to drug shortages.13 14 15 16
QMM评估不用于评估CGMP合规性。CGMP要求是任何药品生产操作的基础。CGMP合规性根据联邦食品、药品和化妆品法案（FD&C法案）第704(a)节11，通过有资质的检查员进行的监督检查或其他检查进行评估。检查是强制性的，并且根据FD&C法案第301(f)节12，拒绝进入或检查是被禁止的。相比之下，QMM评估不是FDA检查权限的一部分，参与QMM计划是自愿的。QMM评估不能用于确定CGMP合规性。QMM评估的重点是评估场地内的行为、实践和质量文化。QMM水平越高，表明工艺能力和性能越高，可导致药品短缺的质量失败的风险越低。13 14 15 16

QMM assesses manufacturing establishments; QMM does not evaluate product quality. QMM assessments cannot and do not evaluate the quality of specific products. FDA evaluates product quality throughout the lifecycle by assessing regulatory submissions, post-market quality defect reports (e.g., field alert reports, biological product deviation reports, MedWatch reports, consumer complaints), sampling and testing results, and through CGMP inspections.
QMM评估生产场地；QMM不评估产品质量。QMM评估不能也不会评估具体产品的质量。FDA通过评估监管申请、上市后质量缺陷报告（例如，现场警示报告、生物制品偏差报告、MedWatch报告、消费者投诉）、取样和检测结果以及通过CGMP检查来评估整个生命周期内的产品质量。

Maturity is independent of establishment size or age, and the types or number of products produced. QMM assessments focus on evaluating if a culture of quality exists at the establishment and how this mindset is reflected in the quality practices employed. Therefore, these evaluations are not product-specific, and the maturity of an establishment is not dependent on factors like establishment size or age, and the types or number of products that are manufactured, tested, processed, packaged, labeled/re-labeled, or held. Simply having larger profit margins does not mean an establishment is highly mature. For example, establishments with greater financial resources that purchase state-of-the-art equipment may not be highly mature if their use of resources and technology is not fit for purpose and appropriately controlled. Rather, establishments with a highly mature quality culture use practices that invest time and resources commensurate with their financial resources to proactively improve their operations.
成熟度与场地规模或使用时长以及所生产产品的类型或数量无关。QMM评估的重点是评估场地是否存在质量文化，以及这种理念如何反映在所采用的质量实践中。因此，这些评估不是针对特定产品的，场地的成熟度不取决于场地规模或使用时长，以及生产、检验、加工、包装、贴签/重新贴签或贮存的产品类型或数量等因素。仅仅拥有较大的利润率并不意味着场地是高度成熟的。例如，采购最先进设备的财力较大的场地，如果对资源和技术的使用不适合其用途并且没有得到适当控制，则这些场地可能不是高度成熟的。相反，具有高度成熟质量文化的场地会投入与其财务资源相称的时间和资源，来主动改进其运营。

QMM assessments are distinct from the collection of Quality Metrics. Quality metrics (QM) are quantitative data that are collected and reviewed by establishments to determine the capability and effectiveness of manufacturing processes and systems. On the other hand, QMM assessments are qualitative and focus on approach, including understanding why establishments select and define specific metrics for monitoring and how they leverage data to drive continual improvement.
QMM评估不同于质量量度的收集。质量量度（QM）是由场地收集和回顾的定量数据，以确定生产工艺和系统的能力和有效性。另一方面，QMM评估是定性的并关注方法，包括理解场地为什么选择和确定具体的量度进行监测，以及他们如何利用数据来推动持续改进。　

QMM is NOT an additional burden or requirement. It is, in fact, integral to an establishment's quality system. Most establishments already have processes and practices aligned with QMM. Achieving higher levels of QMM naturally results from an establishment's proactive continual improvement efforts. Investing in a culture of quality should not require the creation of new departments; a quality culture should be integral to the quality system. Moreover, the benefits of improving quality systems are well-known and can lead to long-term cost savings.17 Each establishment makes decisions regarding how and where to invest resources, and this decision should consider the return on investment, not just the initial cost.
QMM不是额外的负担或要求。事实上，它是场地质量体系不可或缺的一部分。大多数场地已经具备与 QMM 相一致的工艺和实践。场地积极主动的持续改进自然会实现更高水平的QMM。在质量文化方面的投入不应该要求创建新的部门；质量文化应是质量体系不可或缺的一部分。此外，提升质量体系的益处是众所周知的，可以带来长期的成本节约。17 每个场地就如何以及在何处投入资源做出决策，该决策应考虑投入的回报，而不仅仅是最开始的成本。

Conclusion
结论
The QMM program seeks to promote a strong culture of quality, recognize establishments with robust quality management practices, and provide support and recommendations for areas where quality management practices can be enhanced. Through the program, industry participants and QMM assessors can work together to drive proactive continual improvement in the pharmaceutical industry.
QMM计划旨在促进良好的质量文化，认可具有稳健质量管理实践的场地，并为质量管理实践可以加强的领域提供支持和建议。通过该计划，行业参与者和QMM评估人员可以共同推动制药行业的主动持续改进。　

The QMM prototype assessment protocol that CDER is developing will offer a structured, objective approach to evaluate an establishment's level of maturity in the five practice areas described in this paper. Management's commitment to quality sets the tone for the entire organization, ensuring that quality is prioritized, aligned with business objectives, and resourced appropriately. Business continuity ensures operational resiliency, safeguarding against disruptions and minimizing risks to the supply chain. An advanced PQS takes advantage of learnings gained across products and from all stages of the product lifecycle to optimize process performance and product quality. Technical excellence promotes the acquisition of new skills and the implementation of advanced manufacturing and analytical methods that are fit for purpose, driving operational excellence. Finally, employee engagement fosters a culture of quality throughout the organization, empowering employees to actively contribute to continual improvement and patient safety.
CDER 正在开发的 QMM 原型评估方案将提供一种结构化、客观的方法来评估场地在本文件中描述的五个实践领域的成熟度水平。管理层对质量的承诺为整个组织定下基调，确保质量被优先考虑，与业务目标相一致，并提供适当的资源。业务连续性确保运营弹性，防止中断并最大限度地减少供应链的风险。先进的PQS利用从产品和产品生命周期所有阶段获得的经验来优化工艺性能和产品质量。卓越的技术促进了新技能的获得以及先进的适合于目的的生产和分析方法的实施，从而推动了卓越的运营。最后，员工敬业度促进整个组织中的质量文化，使员工能够为持续改进和患者安全做出积极贡献。　

By focusing on these practice areas, the prototype assessment protocol will encourage establishments to embrace a holistic approach to quality management. The QMM assessment will identify areas of strength in quality management practices and provide recommendations for impactful growth opportunities. Through collaboration between industry participants and the QMM assessors, the prototype assessment protocol will help support the development of a shared understanding of a commitment to quality, ultimately leading to a more reliable drug supply and positive patient outcomes.
通过专注于这些实践领域，原型评估方案将鼓励场地采用整体方法进行质量管理。QMM评估将确定质量管理实践中的优势领域，并为有影响力的提升机会提供建议。通过行业参与者和 QMM 评估人员之间的合作，原型评估方案将有助于形成对质量承诺的共同理解，最终实现更可靠的药品供应和积极的患者结果。　

hh0915

感谢分享，好人一生平安

chengks

质量管理成熟度的原文
https://www.fda.gov/media/171705/download?attachment

神佑

谢谢，学习学习！