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近日，WHO發(fā)布了新的技術(shù)報告TRS1060，包含以下內(nèi)容：

 

WHO藥品GMP：總則的修訂計劃

WHO關(guān)于藥品中亞硝胺預(yù)防與控制的良好實踐考慮

WHO 藥用輔料GMP

血液機構(gòu)的良好實踐指南

關(guān)于醫(yī)藥產(chǎn)品制造和檢查的良好實踐指南的建議

WHO藥品供應(yīng)鏈質(zhì)量保證模型的更新計劃

 

WHO GMP for pharmaceutical products: main principles

 

WHO 藥品 GMP： 總則

 

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成員介紹了修訂《WHO藥品良好生產(chǎn)規(guī)范：總則》的最新進展（11）?，F(xiàn)有指南描述了質(zhì)量管理的 主要原則，以降低風(fēng)險并確保藥品的一致生產(chǎn)和控制，使其能夠滿足安全性、有效性和質(zhì)量要求。它就清潔消毒、處理投訴、產(chǎn)品召回和合同生產(chǎn)等問題提供了指導(dǎo)，并強調(diào)了建立涵蓋生產(chǎn)、清潔消毒、驗證、人員和設(shè)備各個方面的全面質(zhì)量體系的重要性。

 

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 年關(guān)于醫(yī)藥產(chǎn)品生產(chǎn)和檢查良好實踐的磋商會上，專家們在關(guān)于脫氯乙二醇/雙乙二醇污染的不合格藥品的幾次警報的推動下，建議修訂世衛(wèi)組織藥品良好生產(chǎn)規(guī)范：確保更嚴格控制和供應(yīng)商確認要求的 主要原則，以有效防止進一步的乙二醇和雙乙二醇污染事件。2023 年 10 月的第 57 屆ECSPP 也響應(yīng)了這一建議。

 

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

 

在第 57 屆 ECSPP 之后，提議更新后的指南將強調(diào)：

 

EG and DEG contamination

EG 和 DEG 污染

supplier qualifications

供應(yīng)商確認

enhanced pharmaceutical quality systems

增強的藥品質(zhì)量體系

manufacturers’ reporting obligations and recall mechanisms.

制造商的報告義務(wù)和召回機制。

 

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.

 

在起草任何修訂之前，已與 GMP 檢查員共享現(xiàn)有指南，以獲取有關(guān)差距和修訂需求的反饋。收到的意見強調(diào)需要進行修訂，以側(cè)重于與更新的監(jiān)管標準保持一致，特別是關(guān)于ICH Q9 質(zhì)量風(fēng)險管理（12）。他們建議引入基于健康的暴露限值，以改進交叉污染和高危害物料處理部分;以及更加重視改善供應(yīng)鏈控制、主動管理和基于風(fēng)險的決策。

 

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 月舉行的關(guān)于醫(yī)藥產(chǎn)品生產(chǎn)和檢驗良好實踐的非正式磋商中，專家組討論了收到的所有意見。專家組建議對相關(guān)的全球制造和檢驗規(guī)范和標準（例如，ICH、PIC/S、歐盟、FDA、ISO）進行范圍界定審查，以確定現(xiàn)有的國家、區(qū)域和國際法規(guī)和最佳實踐。該審查還將包括對適用的 WHO 指南的比較分析，以評估它們是否也需要修訂。

 

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，范圍審查的結(jié)果將為修訂 《WHO 藥品良好生產(chǎn)規(guī)范：總則》提供信息，并確定是否還需要更新任何其他WHO GMP 和檢查指南（例如，WHO 質(zhì)量風(fēng)險管理或驗證指南）。范圍界定審查的結(jié)果以及修訂GMP  總則和其他指南的計劃將于2025 年提交給第 59 屆 ECSPP，以供參考和討論。

 

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 討論了更新 《WHO 藥品良好生產(chǎn)規(guī)范： 總則》的擬議方法。它同意，與其他準則的比較分析和調(diào)整工作可能需要大量的時間和精力，并建議在修訂提案中包括對資源需求和優(yōu)先次序的考慮，以確保計劃切合實際。它建議采用交錯的方法進行比較分析，例如，首先關(guān)注自現(xiàn)有GMP  總則發(fā)布以來十年中采用的WHO 指南。

 

技術(shù)報告還以附件形式發(fā)布了一下文件的最終版本：

 

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

 

附件 1 藥物制劑規(guī)范專家委員會通過的指南文件

 

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

 

附件 2 WHO預(yù)防和控制藥物成品中亞硝胺的良好實踐考慮

 

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

 

附件 3 WHO 藥品用輔料GMP

 

Annex 4 Good practices for blood establishments

 

附件 4 血液企業(yè)的良好實踐

 

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 生物豁免清單：豁免 WHO基本藥物口服速釋固體劑型標準清單的體內(nèi)生物等效性要求的建議

 

Annex 6 Guideline on bioanalytical method validation and study sample analysis

 

附件 6 生物分析方法驗證和臨床試驗樣品分析指南

 

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

 

附件 7 國家監(jiān)管機構(gòu)實施醫(yī)藥產(chǎn)品協(xié)同注冊程序的良好實踐