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SCHEDULEFOR DRAFT WORKING DOCUMENT QAS/19-802:
ENVIRONMENTALASPECTS OF GOOD MANUFACTURING PRACTICES:
POINTSTO CONSIDER FOR MANUFACTURERS AND INSPECTORS IN THE PREVENTION OF ANTIMICROBIALRESISTANCE
GMP中的环境问题：生产商和检查员在防止抗菌剂耐药性方面的考虑要点
1. INTRODUCTION AND SCOPE 介绍与范围
1.1. Background 背景
Growing antimicrobial resistance (AMR) linked to the discharge of drugs and particular chemicals into the environment is one of the most worrying health threats today, according to research by UN Environment (1). AMR accounts for an estimated 700 000 deaths per year and, by 2030, will represent up to US$ 3.4 trillion in Gross Domestic Product (GDP) loss (2). AMR has been identified as a priority at the World Health Assembly since 1998 (3), with rising momentum throughout the years. Since 1998, there have been a series of resolutions on AMR. This paved the wayto the Sixty-eighth World Health Assembly in May 2015, where the World Health Assembly endorsed a global action plan to tackle AMR, including antibiotic resistance, the most urgent drug resistance trend (4). More recently, the Thirteenth General Programme of Work (2019-2023) highlighted the need to address this emerging threat under the section for «Tackling antimicrobial resistance» (2). It is only recently that the need to address waste and waste water management from pharmaceutical production has been explicitly addressed. Namely, on 30 November 2018, the World Health Organization’s (WHO) Executive Board meeting decided that technical input will be provided to Good Manufacturing Practice (GMP) guidance on waste and wastewater management from the production of Critically Important Antimicrobials (5, 6). This “points to consider” document was written furtherto this recent decision.
根据UN环境研究，当前由于药品尤其是化学品排放至环境中而日益增长的抗生素耐药性（AMR）已成为最令人担忧的健康威胁。AMR每年造成约70万人死亡，到2030年将造成高达3.4万亿美元GDP损失。自1998年以来，AMR已被WHA作为优先事务持续推进。自1998年以来，在AMR方面已有了一系列的解决方案。这为2015年5月第68次WHA铺平了道路，会议中WHA通过一项全球计划应对AMR，包括抗生素耐药性、最紧急药物耐药性趋。最近的第13次常务工作计划（2019-2023）在“应对抗生素耐药性”章节强调了解决此紧急威胁的需要。直到最近才清楚提出了药品生产中废水废物管理的需要。也就是说，在2018年11月30日，WHO执行董事会议决定针对特别重要抗菌剂的生产提出废物废水管理方面的GMP指南。本考量要点文件是对最近决定的响应。
This document is to be considered as a time-limited document that addresses the current needs for guidance on how GMPs should be implemented to waste and waste water management for production of antimicrobials, with a focus on Critically Important Antimicrobials. Wherever possible, this text is informedby relevant evidence. However, the evidence base may be weak in some areas, therefore inputs from stakeholders and experts could be beneficial.
本文应作为暂时解决当前指南需求的文件，指导如何实施抗菌剂生产中的废物和废水管理GMP，重点在于特别重要的抗菌剂。虽然本文尽可能采用相关证据，但这些证据可能在某些领域比较薄弱，因此干系人和专家们如能提出建议将大所裨益。
1.2. Purpose目的
Thepurpose of this document is to: 本文件的目的是
• Raise awareness of medicines’ manufacturers, GMP inspectors and inspectorates in all Member States on sections of relevant GMP guidance that are applicable to the management ofwaste/waste water from the production of antimicrobials.
• 提高药品生产商、GMP检查员和所有成员国检查团队在适用于抗菌剂生产的废物/废水管理相关GMP指南方面的意识。
• Provide clarification on the interpretation of those clauses and specific measures that should be taken tobe considered compliant with the relevant sections of GMP guidance.
• 对这些条款解释提供澄清，以及在符合GMP指南相关部分时应考虑采取的具体措施提供解释。
• Raise awareness of medicine’s manufacturers, GMP inspectors and inspectorates, on the importance of considering all aspects of GMP implementation and to also focus on the parts of GMP that may not have a direct product quality impact.
• 提高药品生产商、GMP检查员和检查团队考虑GMP实施所有方面重要性的意识，同时关注可能对药品质量产生直接影响的GMP部分。
• Raise awareness of Member States, to establish and enforce requirements for their local pharmaceutical production facilities to safely dispose of the waste and waste water that is generated while manufacturing antimicrobials, with a focus on Critically Important Antimicrobials.
• 提高成员国建立和执行其本地药品生产设施的意识，以安全处理抗菌剂生产过程中产生的废物和废水，同时关注特别重要的抗菌剂。
• Provide proposals on what should be done by the different stakeholders in order to help control and reduce contamination of the environment with antimicrobials and related chemicals coming from pharmaceutical production processes.
• 为不同干系人提供行动方案，以帮助控制和降低环境中来自药品生产工艺的抗菌剂和相关化学品污染。
• Discuss options and tools to reduce and mitigate the uncontrolled disposal of waste and waste water containing antimicrobials when manufacturing medical products, with a focus on how GMP can more comprehensively address environmental aspects in the prevention of AMR, including the potential role of inspectors to tackle this issue. This includes:
• 讨论降低和缓解药品生产中含抗菌剂的废物与废水不受控处理的方法和工具，同时关注GMP如何能更全面解决环境中AMR预防问题，包括检查员应对此问题的可能身份。其中包括：
o a presentation of a pilot process in the WHO Prequalification (PQT) Inspectorate to comprise verification of adequate preventive measures in place to prevent environmental contamination with Critically Important Antimicrobials manufactured at medicines manufacturing facilities, involving both active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP) production facilities;
o 在WHO预认证（PQT）检查开始阶段中包括对预防措施是否充分的核查以预防在药品生产场所中所生产的特别重要的抗菌剂环境污染，包括API与FPP生产场所。
o a discussion of a proposal to update GMP guidelines, with a focus on the guidelines WHO good manufacturing practices forpharmaceutical products containing hazardous substances (Annex 3, TRS957, 2010)(7);
o 讨论GMP指南更新方案，重点关注指导WHO 含危险物质的药品GMP（附录3，TRS957，2010）
o a discussion of the creation of anetwork/forum coordinated by WHO to share information, experience andmechanisms for reporting eventual potential breaches of national/internationallaws on waste discharge; and
o 讨论WHO协调创建一个网络/论坛，分享报告可能违反国家/国际废物排放法律的信息、经验和机制。
o a proposal to initiate an awarenesscampaign among Member States, which includes GMP inspectors.
o 提出在成员国间启动一个宣传活动，其中包括GMP检查员。
• Gather stakeholders’ inputs on potential way forwards to tackle AMR, including successful experiences and best practices when manufacturing pharmaceutical products.
• 收集干系人的AMR应对方法建议，包括在药品生产时的成功经验和最佳实践。
This document is not intended to cover AMR issues that are related to the clinical or veterinary setting or to other types of environmental contamination (1) (such as the excretion of antimicrobials during their use).
本文件无意覆盖与临床或兽药设置有关的AMR问题或其它类型污染（例如在抗菌剂使用过程中的排泄）。
1.3. Target audience 目标读者
This document is primarily targeted to:
本文件目标读者为
• All manufacturers of antimicrobials whoare involved in the manufacturing of API and FPPs.
• 所有从事API和FPP生产的抗菌剂生产商
• GMP inspectors and inspectorates from national medicines regulatory authorities.
• GMP检查员和国家药监机构的检查团队
• Regulatory bodies that are responsible for enforcing environmental protection standards and waste/waste water management in all Member States; consistent with a multidisciplinary approach, the Ministries of Health, Ministries of Environment or Pollution control boards and Ministries of Agriculture, as appropriate.
• 在所有成员国负责执行环境保护标准和废物/废水管理的监管机构，采用多学科方法，卫生管理、环境或人口控制管理委员会和农业局（适当时）
• Waste and waste water management services who handle antimicrobial waste and/or process effluents from the pharmaceutical industry.
• 处理制药行业抗菌剂废物和/或工艺排放的废物和废水管理服务方
• Procurement agencies who are purchasing antimicrobials and, more particularly, Critically Important Antimicrobials, who include a verification of compliance with GMP requirements as part of their quality assurance process and/or who aim to purchase antimicrobial medicines from companies who have sustainable and environmentally respectful production processes.
• 采购抗菌剂，尤其是特别重要的抗菌剂的采购机构，其机构将GMP合规核查作为其质量保证流程的一部分，和/或目的是从可持续和环境友好生产工艺的公司采购抗菌药品
• NGOs and other non-state actors who are involved in monitoring and mitigating AMR.
• 参与AMR监测和降低的NGO和其它非国家行动者
• Experts in environmental development and the spread of AMR, with a focus on the release of antimicrobials from manufacturing.
• 环境发展和AMR传播专家，同时关注生产后抗菌剂放行
• Experts in waste and waste water treatment technologies applicable in antimicrobial manufacturing.
• 适用于抗菌剂生产的废物和废水处理技术专家
