WHO 发布 TRS 1067 附录 2，提出药品连续制造考虑要点
TRS 1067 - Annex 2: WHO points to consider in continuous manufacturing of pharmaceutical products
WHO 发布 TRS 1067 附录 2，提出药品连续制造的考虑要点。文件分章列出效益与挑战、良好实践、风险管理、控制策略、工艺动态、计算机化系统、验证与确认及稳定性试验等内容，并说明应与 ICH Q13 和 WHO GMP 一并阅读。文中示例以口服固体制剂为主，指出相关原则可延伸至其他剂型、生物制品和疫苗。
文件围绕连续制造列出风险管理、控制策略、工艺动态与验证等要点，并以口服固体制剂示例说明适用范围。
译文尚不完整，完整内容请切换到原文。
WHO 正式技术报告附录：TRS 1067 - 附录2：WHO 关于药品连续制造需考虑要点的考量
官方目录发布日期：2026-06-09（原文 9 June 2026）；报告年份、会议日期及适用范围请以文件正文为准。
官方出版页：https://www.who.int/publications/m/item/trs-1067---annex-2--who-points-to-consider-in-continuous-manufacturing-of-pharmaceutical-products
PDF 文字版；图形和原始排版请参阅官方 PDF。
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附件2
WHO关于药品连续制造需考虑的要点的指导原则
如需更多信息或提出请求，请发送电子邮件至WHO药品标准与规范（NSP）团队，邮箱：[email protected]。
目录
1. 引言 96
2. 术语 97
3. 连续制造的优势与挑战 98
3.1 技术与操作挑战 99
3.2 监管挑战 100
3.3 人员队伍挑战 100
4. 良好规范考虑 100
5. 风险管理 101
6. 控制策略 102
7. 过程动态 104
8. 计算机化系统 105
9. 验证与确认 105
10. 稳定性试验 105
参考文献 106
延伸阅读 106
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WHO 药品制剂规格专家委员会第五十九次报告
1. 引言
原料药（APIs）、辅料和
成品药（FPPs）的生产商主要采用批
加工方式作为其产品的生产手段。
近年来，若干生产商选择在药品生产中引入连续
制造（CM）。尽管 CM 在药品生产中是相对
较新的方法，但这一概念已在其他行业应用了
近一个世纪。有若干行业采用这一方法的实例，
包括炼油、金属冶炼、
石化产品制造，以及某些辅料、食品和饮料
制造。
CM（在适当情况下包括流动化学）可应用于
某些化学品、起始物料（辅料和原料药）和成品药的生产。
CM 需要自动化系统，例如对输入物料进行计量（至少
如此），以确保可持续且受控的生产过程。
在 CM 过程中，输入物料被连续送入
并在过程中发生转化，处理后的输出物料被
连续从系统中移出。这一描述可适用于
单个单元操作，或由一系列单元操作组成的
整个生产过程。
CM 不必在产品生产中端到端应用。它可以
应用于生产过程中的部分（半连续）或全部单元操作。
例如，在口服固体制剂的生产中，某些步骤
（如进料和混合）或全部步骤可纳入 CM。
尽管在 CM 过程中任一给定时刻所处理的物料量
可能相对较小，但该过程可运行一段时间
以生成所需数量的成品物料，满足必要的
WHO Technical Report Series, No. 1067, 2026
质量标准。
在传统的批生产过程中，通常在
某些加工步骤之后进行取样和检测。这往往导致停
机时间和保持时间。相对较新的 CM 方法利用传感器进行在
线和在线分析检测，可能减少此类停机和保持时间。它可能
进一步促进充分利用设备和生产线的产能，
减少人为错误，并支持质量控制和检测。
本文件提出了生产商在原料药和成品药生产中
实施 CM 时需考虑的要点。尽管文件中给出的
示例侧重于口服固体制剂，但这些原则可
适用于其他剂型、生物制品（如治疗性蛋白）和
疫苗（例如通过新型技术生产的疫苗）。本文件
补充了国际人用药品技术要求协调理事会
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附件 2
人用药品技术要求国际协调理事会（ICH）Q13 协调
指南：原料药和制剂的连续制造（1），并且
应与 ICH Q13 和 WHO 药品生产质量管理规范一并阅读。
2. 术语
at-line（近线）。一种系统，其中样品为手动采集，分析仪
位于工艺旁边。
batch（批）。在某一工艺或一系列工艺中生产出的特定数量的物料，
预期在规定的限度内是均一的。在
连续生产的情况下，一批可对应于生产的某一确定部分。
批大小可通过固定数量或通过
在固定时间间隔内生产的数量来定义。
batch size（批大小）。规定的输入物料数量；或输出
物料或产品的数量；或生产规定数量输出物料或产品所需的时间；
或上述各项的组合。
continuous manufacturing（连续制造）。将输入物料连续加入
某一工艺，同时处理后的输出物料连续从系统中移出，
由两个或更多个集成的单元操作组成。
flow chemistry（流动化学）。流动化学也称为连续流或活塞流
化学；它涉及在连续流动流中而非
批次生产中运行的化学反应。
in-line（在线）。一种过程分析技术系统，其被纳入工艺
的流动之中，并使用电容、
光散射、光谱法、在线液相色谱和其他类型的
传感器，在不取样的情况下产生连续数据。
on-line（线上）。一种直接连接到工艺并采集和
自动分析样品的系统，样品从不返回工艺。
pharmaceutical product（药品）。任何拟供人或
兽用、以其成品剂型呈现或作为用于此类剂型的起始物料
的任何物料或产品，其在出口国或进口国
受药品法规控制。
process analytical technology（过程分析技术）。一种通过测量
中间体或产品的质量属性并监测影响
关键质量属性的工艺参数，来设计、分析和控制
生产工艺的机制。
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过程控制。为达到预期结果而对过程进行监测和调整的做法。它是工程学与统计学的结合，涉及使用算法、机制和架构，将过程的输出维持在特定范围内。
过程动态。生产工艺对变化的输入、条件或瞬态事件的响应。瞬态事件是过程经历动态变化的临时状态。这种变化可能是由于扰动或所选操作条件的故意改变（例如，启动、停机或从一种操作条件变为另一种操作条件）。
质量源于设计。一种系统化的开发方法，始于预定义的目标，并基于可靠的科学和质量风险管理，强调对产品和过程的理解以及过程控制。
实时放行检测。基于过程数据评估并确保中间产品或最终产品质量的能力，这些数据通常包括所测物料属性与过程控制的有效组合。
停留时间分布。物料通过特定过程环境、容器或单元操作时所经历停留时间范围的量度。
受控状态。一组控制措施持续保证过程性能和产品质量的一种状态。
其他定义见 WHO 药品质量保证术语数据库：https://www.who.int/publications/m/item/quality-assurance-of-medicines-terminology-database。
WHO 技术报告系列，第 1067 号，2026 年
3. 连续制造的优势与挑战
CM 的优势与挑战已在各类指南和文章中有所描述（见“延伸阅读”部分）。
与传统批处理相比，CM 可在更短时间内提高产品产量。由于操作人员的暴露风险较低，它还可能带来安全方面的益处。
在某些情况下，CM 可支持经济与环境的可持续性。应考虑环境影响、水和能源消耗，以及资本和运营成本的评估。
CM 也可能给生产商带来挑战。这些挑战包括就新概念对人员进行专门培训、管理产品切换以及此类生产线的清洁。
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附录 2
鉴于 CM 相关的技术、运营和经济挑战以及
风险，希望从批生产转向 CM 工艺的生产商必须确保具备
足够的工艺知识，以促进风险管理以及适当控制策略的制定和
实施。如果从批操作转向连续操作，则需要通过教育和表征获得
成分和工艺知识，以确保适当的控制策略。
制药行业采用 CM 面临的挑战包括：
■ 技术问题（例如，工艺知识）；
■ 物流方面的顾虑（例如，新设备和计算机化
系统）；
■ 先进的控制策略，包括复杂的分析
仪器和技术，以使用稳健可靠的方法改进工艺控制
（例如，在线、线上和近
线分析）；
■ 针对关键质量属性和关键
工艺参数的实时数据策略（例如，以维持受控状态）；
■ 监管不确定性（例如，各国
不同的监管要求）；
■ 整合下游单元操作（例如，
半连续生产）；
■ 人员（例如，特定培训和资质）；
■ 风险（包括实际风险和感知风险）；
■ 经济问题（例如，投资回报）；
■ 灵活性问题（例如，调整工艺）。
用于临床应用的批间变异性和纯度仍然是实施过程中
最大的挑战之一（即，满足现行药品生产质量管理规范和良好实验室规范的连续
工艺）。
3.1 技术和运营挑战
缺乏适合小规模 CM 生产线的市售设备，这对制剂和开发设施以及
商业生产商都构成了挑战。
临床试验期间生产和使用的批次与商业批次之间联系的重要性
也不应被低估。
操作人员应了解与工艺控制相关的复杂性以及因设备、传感器或计算机化
系统故障而产生的相关风险，这些故障会导致物料流不连续、过量填充、
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超压、泄漏和物料回流。因此，操作人员应经过
良好的培训和资质确认。
3.2 监管挑战
此外，虽然 CM 与诸如美国食品药品监督管理局和 ICH 等
国际指南高度一致，但药品
生产是一项全球性事业，企业必须为其产品在多个
拥有各自监管机构的国家获得批准。并非所有
监管机构都已针对 CM 制定要求和标准。
当从现有的批生产工艺变更为
CM 工艺时，可将连续工艺作为新产品的
新工艺引入，或作为批准后生产变更引入。在需要时，
应证明具有可比质量和生物等效性（另见 ICH
Q13 (1) 风险、变更和培训）。
可能需要开展更多工作和协调统一，以解决与 CM
相关的监管挑战和要求方面的问题。
3.3 人员队伍挑战
设计、实施和充分监管生产中的新方法
需要既具备生产技能和良好培训，又熟悉
监管环境的人员。
生产、质量控制、质量保证、工程和监管职能
方面的人员可能需要额外培训，因为
CM 中可能需要专用设备、传感器、反馈系统、计算机化系统和
数据管理。
4. 良好规范考虑
WHO 技术报告系列，No. 1067，2026
CM 中的良好规范考虑应从产品和工艺
开发阶段开始。
CM 可能要求生产商购置新设备；实施管理现有
设备的新方式；购置新仪器、计算机化
系统和软件；并建立新的操作模式。这可能进一步
包括转向应用过程分析技术和质量
源于设计原则。
厂房和设施应适合支持 CM。
设备应在 CM 工艺持续期间保持
在运行规格范围内。
药品质量体系应经过适当设计并
得到适当实施和维护 (2)，包括通过物料和
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附录 2
工艺管理；确认与验证；以及维护、校准
和监测。其他药品质量体系要素包括风险
管理、工艺能力指数、工艺性能指数、偏差
管理、事件与不符合（包括物料
分流和扰动）管理、产品稳定性以及控制策略。
产品中使用的原材料和起始物料应可追溯，并
持续符合预定质量标准。由于在 CM 中可能在不同时间
引入多批原材料，可追溯性至关重要。这将需要
了解停留时间分布和工艺动态。
应建立产品收集、不合格物料控制和分流
以及产品拒收的系统。需要了解停留
时间分布和工艺动态。
应考虑的其他系统包括：
■ 详细的开机和停机程序；
■ 生产收集和过程取样将如何作为
确保持续工艺性能和产品质量的
手段进行；
■ 工艺验证和持续工艺确认程序；
■ 人员培训程序；
■ 清洁和清洁验证。
应提供适当的资源。
工艺模型可用于开发 CM 工艺或
优化工艺参数，以建立控制状态、分流策略、
物料可追溯性和工艺动态。
工艺参数（包括其设定值和实时数据）应
作为控制策略的一部分进行控制和监测。
5. 风险管理
风险识别、风险和危害评估、风险控制和风险沟通
应成为采用 CM 的药品质量体系的
组成部分 (3, 4)。
在进行风险评估时，可考虑使用适当的工具
——例如失效模式和影响分析或风险矩阵——
进行定量或定性分析。
应在产品生命周期的各个阶段进行
风险评估，从开发到技术转移再到商业化 CM。
至少需要将物料采购和控制、设备、
工艺步骤和清洁相关的风险纳入
评估。应绘制出每个工艺步骤或单元操作
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indicating, as appropriate, quality attributes and process parameters. Risks and
harms can then be assessed and controls identified.
Consideration should be given to:
■ input material attributes, including their impact on process
operations and product quality (note: process performance may
vary where input material attributes are not consistent – flowability,
particle size and distribution, cohesion, hygroscopicity and other
attributes should be considered in the selection of material, and the
manufacturer of the materials should be qualified as part of vendor
qualification);
■ process steps, including operating parameter settings (for example,
time, temperature, rotation per minute, amperage, speed, and
pressure during sifting, milling, blending, granulation, drying,
compression, filling, sealing and coating);
■ unexpected disturbances, possible deviations and non-
conformances (for example, poor material flow, vibration, product
build-up and material diversion).
The performance of computerized systems and the risks and impact
associated with failure of such systems should be considered.
Appropriate means should be identified for the detection and handling of
non-conforming material.
Risk assessment should be thorough to provide assurance that the
required controls are identified and are effective to ensure that a state of control
is achieved.
6. Control strategy
WHO Technical Report Series, No. 1067, 2026
The control strategy for CM in commercial production should be initiated during
the developmental phase of pharmaceutical products.
The control strategy should be based on the outcome of the risk assessment.
The control strategy should be clearly defined and describe all steps to
ensure that the state of control is achieved. Relevant elements include input
materials, residence time distribution, process dynamics, process monitoring,
material diversion, real-time release testing (if applicable), specifications and
process equipment.
The control strategy should have the ability to detect process departures,
thereby enabling timely corrective actions to be taken to bring the process back
into conformance.
Achieving and maintaining a state of control require appropriate
measures to be taken relating to the management of raw and starting materials;
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Annex 2
specifications; traceability; process monitoring; sampling; intermediates;
equipment; and product collection and rejection.
Mechanisms should be in place to identify any drift in parameters or data
trend that may be of concern. The root cause should be identified for significant
transient events to ensure that appropriate action is taken.
In addition to traceability, it may be necessary to have additional controls
when multiple lots of a raw material are used during CM.
Maintaining a state of control should provide assurance of consistent and
desired product quality.
In ensuring that the manufacturing process is in a state of control, at least
the following aspects should be considered and clearly defined:
■ start-up, pauses and shutdown;
■ in-process monitoring and control, with material collection and
diversion of non-conforming materials;
■ critical process parameters and critical quality attributes at various
stages in the process.
Flowcharts indicating processing steps, continuous and semicontinuous
steps and clear indication of location of sensors and probes may be useful.
The appropriate means of monitoring the process should be implemented.
Sampling should be defined. This includes a clear description of the number of
samples; frequency of sampling; sample size; sample location; in-line, on-line,
off-line or at-line sampling; and limits and acceptance criteria.
The objectives of sampling, collecting and processing data should be
clear, as data may be used in statistical analysis and trending. Set points and
control limits should be appropriate. It may be possible to apply new approaches
in technology and methodology in CM. CM affords more flexible handling
compared to traditional batch manufacturing. Process parameters may be
adjusted during processing based on measuring and results of quality attributes of
the intermediate or in-process material, in real time, using (for example) process
analytical technology. In-line sensors and devices may be useful to enable real-
time identification of departures from expected results.
Validated systems should be in place to manage diversion of potentially
non-conforming materials.
Based on process knowledge and understanding, the elements of a control
strategy for CM include:
■ measuring process parameters and critical quality attributes in a
timely manner;
■ maintaining the process in a state of control;
■ maintaining the product attributes within specifications;
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WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-ninth report
■ appropriate use of artificial intelligence;
■ optimizing process operation;
■ realization process operation;
■ realizing process efficiency improvements.
7. Process dynamics
Scientific knowledge supported by experimental data of the process dynamics
and variables are needed to ensure that CM processes are appropriately designed,
managed and operated within a state of control. Knowledge is required of the
differences that may exist between developmental batch and commercial batch
processing.
Processing steps in CM need to be well controlled to ensure the
production of uniform products and thus require different approaches in process
parameter control and monitoring. As an example, fluctuation in feed of raw
material may impact the quality of a blend. For improved monitoring and control
of the processing parameters, manufacturers may have to consider specifically
designed equipment and instrumentation, computerized systems, and feedback
systems. The selection of equipment and instrumentation should be suitable
for its intended purpose and process for semicontinuous and continuous
manufacturing, as applicable.
To obtain meaningful results, consideration should be given to:
■ instrument selection and suitability for process conditions;
■ analytical procedures and their development to ensure accuracy and
robustness;
■ sensor and probe placement for representative data collection;
WHO Technical Report Series, No. 1067, 2026
■ critical process parameters (such as flow rate, particle size
distribution, compression force), including maintenance, servicing
and calibration;
■ system performance (including accuracy, operating range and
sensitivity);
■ data integrity and compliance with good practice requirements,
including computerized system validation;
■ sampling strategy (method, location, frequency, representativeness
and sample size);
■ consistency in analysis across the expected concentration range;
■ acceptance criteria aligned with product quality attributes and
regulatory expectations.
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Annex 2
8. Computerized systems
Computerized systems should be appropriate for their intended use.
Computerized systems should be appropriately validated and be able to
ensure the integrity of data (5, 6).
9. Validation and verification
The principles of process validation, as described in WHO guidelines, should
be considered (7). In addition, specific attention should be given to start-up and
shutdown of the process, process run time evaluation, and the ability to detect
process excursions. Examples may include process robustness, process flow rate
and residence time.
In CM, careful consideration should be given to the manner in which
process performance and quality attributes are consistently controlled by the
control strategy.
Process monitoring is dependent on residence time distribution. Real-
time data collection and analysis during sampling should be representative of the
process to ensure that transients outside the state of control are detected.
Where a traditional approach in process validation is followed,
consideration should be given to the number of batches required for process
validation. Any variation in results of attributes between different batches should
be within an acceptable range. Consideration should be given to the possible
impact on the process capability where differences in quantities and times
(resulting in different batch sizes) in different batches are employed in CM.
10. Stability testing
Stability data for products manufactured by means of CM should be available.
The same principles for stability testing apply as outlined in WHO guidelines for
stability testing (8).
The selection of batches and the number of batches of product that should
be subjected to stability testing should be justified.
Consideration should be given to variables that may be impacting the
batches, such as the number of batches of input material to the batch of product
and batch size.
Unless otherwise justified, stability data from commercial batches
should be available and derived from batches where the state of control has been
demonstrated.
Consideration should be given to the impact on stability of changes in
such elements as run time, scale-out and process flow rate.
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References
1. Continuous manufacturing of drug substances and drug products. ICH Harmonized Guideline
Q13. Geneva: International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use; 2022 (https://database.ich.org/sites/default/files/ICH_Q13_
Step4_Guideline_2022_1116.pdf).
2. WHO good manufacturing practices for pharmaceutical products: main principles. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations: forty-eighth report (Annex 2).
Geneva: World Health Organization; 2014 (WHO Technical Report Series No. 986; https://iris.who.
int/handle/10665/112733).
3. WHO guidelines on quality risk management. In: WHO Expert Committee on Specifications for
Pharmaceutical Preparations: forty-seventh report (Annex 2). Geneva: World Health Organization;
2013 (WHO Technical Report Series No. 981; https://iris.who.int/handle/10665/81144).
4. Quality risk management. ICH harmonized guideline Q9 (R1). Geneva: International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2023 (https://
www.ich.org/page/quality-guidelines).
5. Good manufacturing practices: guidelines on validation. Appendix 5: Validation of computerized
systems. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-third
report (Annex 3). Geneva: World Health Organization; 2019 (WHO Technical Report Series No.
1019; https://iris.who.int/handle/10665/312316).
6. Guideline on data integrity. In: WHO Expert Committee on Specifications for Pharmaceutical
Preparations: fifty-fifth report (Annex 4). Geneva: World Health Organization; 2021 (WHO Technical
Report Series No. 1033; https://iris.who.int/handle/10665/340323).
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Specifications for Pharmaceutical Preparations: fifty-third report (Annex 3). Geneva: World
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Further reading
■ Burange AS, Osman SM, Luque R (2022). Understanding flow chemistry for the production of
active pharmaceutical ingredients. Iscience. 25(3).
■ Burcham CL, Florence AJ, Johnson MD (2018). Continuous manufacturing in pharmaceutical
process development and manufacturing. Annu Rev Chem Biomol Eng. 9(1):253–81.
■ Gamp I (2008). 5: A risk-based approach to compliant GXP computerized systems. Tampa, Florida:
ISPE.
■ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) (2005). Pharmaceutical development. ICH harmonized guideline Q8 (R2).
Geneva (https://www.ich.org/page/quality-guidelines).
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Annex 2
■ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) (2008). Pharmaceutical quality system. ICH harmonized guideline Q10. Geneva
(https://www.ich.org/page/quality-guidelines).
■ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use (ICH) (2012). Development and manufacture of drug substances. ICH harmonized guideline
Q11. Geneva (https://www.ich.org/page/quality-guidelines).
■ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) (2014). Lifecycle management. ICH harmonized guideline Q12. Geneva (https://
www.ich.org/page/quality-guidelines).
■ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use (ICH) (2022). Continuous manufacturing of drug substances. ICH harmonized guideline Q13.
Geneva (https://www.ich.org/page/quality-guidelines).
■ Matsuda Y (2018). PMDA/JP perspectives on continuous manufacturing (https://www.pmda.
go.jp/files/000241270.pdf).
■ Nasr MM, Krumme M, Matsuda Y, Trout BL, Badman C, Mascia S et al. (2017). Regulatory perspectives
on continuous pharmaceutical manufacturing: moving from theory to practice: September
26–27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals. J
Pharm Sci. 106(11):3199–206.
■ National Academies of Sciences, Engineering, and Medicine; Division on Earth and Life Studies;
Board on Chemical Sciences and Technology (2019). Continuous manufacturing for the
modernization of pharmaceutical production: proceedings of a workshop. Washington (DC):
National Academies Press.
■ Plutschack MB, Pieber B, Gilmore K, Seeberger PH (2017). The hitchhiker’s guide to flow chemistry.
Chem Rev. 117(18):11796–893.
■ United States Pharmacopeia (USP) (2022). Pharmaceutical continuous manufacturing: what drug
makers need to know. Rockville, MD.
■ United States Pharmacopeia (USP) (2023). Pharmaceutical continuous manufacturing: a guide
to control strategies for solid oral dose drugs. Rockville, MD (https://www.usp.org/supply-chain/
pharmaceutical-continuous-manufacturing-usp-technical-guide).
■ United States Pharmacopeia (USP) (2023). Technical guide: process modelling for advanced
manufacturing technologies (AMT). Rockville, MD.
■ United States Pharmacopeia (USP) (2024). Technical guide: in-vitro dissolution modeling for oral
solid drug product continuous manufacturing. Rockville, MD.
■ United States Pharmacopeia (USP) (2025). Control strategy for continuous manufacturing of drug
substances. Rockville, MD.
■ Wegner J, Ceylan S, Kirschning A (2011). Ten key issues in modern flow chemistry. Chem Commun.
47(16):4583–92.
■ World Health Organization (2024). Multisource (generic) pharmaceutical products: guidelines
on registration requirements to establish interchangeability. In: WHO Expert Committee on
Specifications for Pharmaceutical Preparations: fifty-seventh report (Annex 8). Geneva (WHO
Technical Report Series No. 1052; https://iris.who.int/handle/10665/376607).
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来源：WHO 药品质量技术报告与指南 · cdn.who.int