近日，WHO发布了新的技术报告TRS1060，包含以下内容：

 

WHO药品GMP：总则的修订计划

WHO关于药品中亚硝胺预防与控制的良好实践考虑

WHO 药用辅料GMP

血液机构的良好实践指南

关于医药产品制造和检查的良好实践指南的建议

WHO药品供应链质量保证模型的更新计划

 

WHO GMP for pharmaceutical products: main principles

 

WHO 药品 GMP： 总则

 

Dr Estevão Cordeiro and Dr Van Zyl updated ECSPP members on progress in revising the WHO good manufacturing practices for pharmaceutical products: main principles (11). The existing guideline described the main principles of quality management to reduce risks and ensure consistent production and control of pharmaceutical products so that they could meet safety, efficacy and quality requirements. It provided guidance on issues such as sanitation, handling complaints, product recalls and contract production, and highlighted the importance of having a comprehensive quality system that covered of all aspects of production, hygiene, validation, personnel and equipment.

 

向ECSPP成员介绍了修订《WHO药品良好生产规范：总则》的最新进展（11）。现有指南描述了质量管理的 主要原则，以降低风险并确保药品的一致生产和控制，使其能够满足安全性、有效性和质量要求。它就清洁消毒、处理投诉、产品召回和合同生产等问题提供了指导，并强调了建立涵盖生产、清洁消毒、验证、人员和设备各个方面的全面质量体系的重要性。

 

Prompted by several alerts of substandard medicines contaminated with DEG/EG, experts at the 2023 consultation on good practices for health products manufacture and inspections had recommended revising the WHO good manufacturing practices for pharmaceutical products: main principles to ensure stricter controls and supplier qualification requirements that could effectively prevent further incidents of EG and DEG contamination. That recommendation had been echoed by the fifty-seventh ECSPP in October 2023.

 

在 2023 年关于医药产品生产和检查良好实践的磋商会上，专家们在关于脱氯乙二醇/双乙二醇污染的不合格药品的几次警报的推动下，建议修订世卫组织药品良好生产规范：确保更严格控制和供应商确认要求的 主要原则，以有效防止进一步的乙二醇和双乙二醇污染事件。2023 年 10 月的第 57 届ECSPP 也响应了这一建议。

 

Following the fifty-seventh ECSPP, it had been proposed that the updated guideline would highlight:

 

在第 57 届 ECSPP 之后，提议更新后的指南将强调：

 

EG and DEG contamination

EG 和 DEG 污染

supplier qualifications

供应商确认

enhanced pharmaceutical quality systems

增强的药品质量体系

manufacturers’ reporting obligations and recall mechanisms.

制造商的报告义务和召回机制。

 

Before drafting any revisions, the existing guideline had been shared with GMP inspectors for feedback on gaps and revision needs. Comments received had emphasized the need for revisions to focus on aligning with updated regulatory standards, especially ICH Q9 on quality risk management (12). They had suggested introducing health-based exposure limits to improve the section on cross-contamination and hazardous materials handling; and giving greater emphasis to improving supply chain control, proactive management and risk based decision-making.

 

在起草任何修订之前，已与 GMP 检查员共享现有指南，以获取有关差距和修订需求的反馈。收到的意见强调需要进行修订，以侧重于与更新的监管标准保持一致，特别是关于ICH Q9 质量风险管理（12）。他们建议引入基于健康的暴露限值，以改进交叉污染和高危害物料处理部分;以及更加重视改善供应链控制、主动管理和基于风险的决策。

 

All comments received had been discussed by a group of experts at the informal consultation on good practices for health products manufacture and inspection in July 2024. The group of experts had suggested doing a scoping review of relevant global manufacture and inspections norms and standards (for example, ICH, PIC/S, European Union, United States Food and Drug Administration, ISO) to identify existing national, regional and international regulations and best practices. That review would also include a comparative analysis of applicable WHO guidelines to assess whether they also required revision.

 

在 2024 年 7 月举行的关于医药产品生产和检验良好实践的非正式磋商中，专家组讨论了收到的所有意见。专家组建议对相关的全球制造和检验规范和标准（例如，ICH、PIC/S、欧盟、FDA、ISO）进行范围界定审查，以确定现有的国家、区域和国际法规和最佳实践。该审查还将包括对适用的 WHO 指南的比较分析，以评估它们是否也需要修订。

 

The results of the scoping review would then inform the revision to WHO good manufacturing practices for pharmaceutical products: main principles and identify whether any other WHO GMP and inspection guidelines also needed updating (for example, WHO guidelines on quality risk management or validation). Results of the scoping review and a plan for revising the GMP main principles and other guidelines would be submitted to the fifty-ninth ECSPP in 2025 for information and discussion.

 

然后，范围审查的结果将为修订 《WHO 药品良好生产规范：总则》提供信息，并确定是否还需要更新任何其他WHO GMP 和检查指南（例如，WHO 质量风险管理或验证指南）。范围界定审查的结果以及修订GMP  总则和其他指南的计划将于2025 年提交给第 59 届 ECSPP，以供参考和讨论。

 

The ECSPP discussed the proposed approach to updating the WHO good manufacturing practices for pharmaceutical products: main principles. It agreed that the comparative analysis and alignment exercise with other guidelines was likely to require significant time and effort, and recommended including considerations on resource needs and prioritization in the proposal for revision to ensure a realistic plan. It suggested adopting a staggered approach to the comparative analysis, for example by first focusing on WHO guidelines that had been adopted in the decade since the existing GMP main principles were published.

 

ECSPP 讨论了更新 《WHO 药品良好生产规范： 总则》的拟议方法。它同意，与其他准则的比较分析和调整工作可能需要大量的时间和精力，并建议在修订提案中包括对资源需求和优先次序的考虑，以确保计划切合实际。它建议采用交错的方法进行比较分析，例如，首先关注自现有GMP  总则发布以来十年中采用的WHO 指南。

 

技术报告还以附件形式发布了一下文件的最终版本：

 

Annex 1 Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations

 

附件 1 药物制剂规范专家委员会通过的指南文件

 

Annex 2 WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products

 

附件 2 WHO预防和控制药物成品中亚硝胺的良好实践考虑

 

Annex 3 WHO good manufacturing practices for excipients used in pharmaceutical products

 

附件 3 WHO 药品用辅料GMP

 

Annex 4 Good practices for blood establishments

 

附件 4 血液企业的良好实践

 

Annex 5 WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms

 

附件 5 WHO 生物豁免清单：豁免 WHO基本药物口服速释固体剂型标准清单的体内生物等效性要求的建议

 

Annex 6 Guideline on bioanalytical method validation and study sample analysis

 

附件 6 生物分析方法验证和临床试验样品分析指南

 

Annex 7 Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products

 

附件 7 国家监管机构实施医药产品协同注册程序的良好实践

 

 

来源：GMP办公室

关键词： 药品GMP