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11月11日，世界卫生组织（WHO）发布了“研究和开发设施的良好实践” 指南（Good practices for research and development facilities）的征求意见稿。WHO指出，就开发批、中试批生产以及相应的稳定性数据，目前没有相关的法规指南对稳定性、工艺验证和分析方法的开发和验证提出具体要求，因此开发本文件非常有必要。本文件为研发机构提供了有关GMP方面的指南，目的是确保遵循正确的系统，保证产品、工艺、程序和数据的适当性、可靠性和质量。
本指南主体部分分为22个章节，内容如下：
1.背景
2.简介
3.范围
4.质量管理
5.质量风险管理
6.卫生
7.确认与验证
8.外包活动
9.自检和质量审计
10.人员
11.培训
12.设施
13.设备和仪器
14.物料
15.文档
16.加工和工艺验证
17.质量控制
18.稳定性研究
19.分析程序的制定
20.技术转移
21.生命周期方法
22.清洁程序的开发和清洁验证
往期推荐
1-3章：研发设施，要不要GMP？|WHO最新发布指南
4-7章：研发，如何做质量管理？|WHO最新发布指南
8-11章：研发，如何要求外包活动？|WHO最新发布指南
以下是该指南的12-14章的内容：
12. 设施
Premises
12.1. Premises should be located, designed, constructed, adapted and maintained to suit the operations to be carried out.
设施的位置、设计、构造、调整和维护应适合要执行的操作。
12.2. The layout and design should aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the products and activities.
布局和设计应旨在最大程度地减少错误风险，并进行有效的清洁和维护，以避免交叉污染，灰尘或污垢的堆积，并且通常避免对产品和活动产生不利影响。
12.3. Where product dust is generated, measures should be taken to avoid cross-contamination and to facilitate cleaning.
在产生产品粉尘的地方，应采取措施避免交叉污染并促进清洁。
12.4. Premises should be cleaned according to detailed written procedures. Records should be maintained.
设施应按照详细的书面程序进行清洁。记录应予以保留。
12.5. Electrical supply, lighting, temperature, humidity and ventilation should be appropriate.
应有适当的电源、照明、温度、湿度和通风。
12.6. Toilets, rest and refreshment rooms should be separate from production and control areas.
厕所、息室和休闲室应与生产和控制区域分开。
12.7. Animal houses should be well isolated from other areas, with a separate entrance (animal access) and air-handling facilities.
动物房应与其它区域隔离开，并有单独的入口（动物通道）和空气处理设施。
12.8. Storage areas should be of sufficient capacity with proper separation and segregation between materials, based on risk assessment.
根据风险评估，存储区域应具有充分的容量，并在物料之间进行适当的隔离和分离。
12.9. Storage areas should be clean and dry, designed or adapted to ensure the required storage conditions are maintained. Conditions should be controlled, monitored and recorded where appropriate.
储存区域应清洁干燥，通过设计或调整，确保维持所需的储存条件。在适当情况下，应控制、监测和记录条件。
12.10. Segregation should be provided for the storage of quarantined, released and rejected materials and products.
应有不同的分区，以存储隔离、释放和拒收的材料和产品。
12.11. Certain materials, such as highly active, radioactive materials and narcotics, should be stored in safe and secure areas.
某些材料，例如高活性、放射性材料和麻醉品，应存储在安全的地方。
12.12. Materials identified for testing should be sampled in accordance with written procedures and analysed for compliance with their specifications.
对于确定要进行检验的材料，应按照书面程序进行取样，并分析其是否符合质量标准。
12.13. The stages in production, including weighing, compounding, and packaging, should be done in a manner to prevent contamination, cross-contamination and mix-ups.
对于生产的各个阶段（包括称重、配料和包装），应以防止污染、交叉污染和混淆的方式进行。
12.14. Quality control (QC) laboratories should be separated from production areas. They should be designed to suit the operations to be carried out in them. There should be sufficient space, instruments, equipment and the appropriate reference materials, solvents and reagents.
质量控制（QC）实验室应与生产区域分开。它们的设计应适合要在其中执行的操作。应该有充分的空间、仪器、设备以及适当的标准品、溶剂和试剂。
13.设备与仪器
Equipment and instruments
13.1. Equipment and instruments should be located, designed, constructed, adapted and maintained to suit the operations to be carried out. They should allow for effective cleaning and maintenance in order to avoid cross-contamination and a build-up of dust or dirt.
设备和仪器的放置、设计、构造、改装和维护应适合要执行的操作。它们应进行有效的清洁和维护，以避免交叉污染和灰尘或污垢的堆积。
13.2. Pipework, instruments and devices should be adequately marked.
管道、仪器和设备应适当标记。
13.3. Balances and other measuring equipment of an appropriate range and precision should be available for production and control operations and should be calibrated on a scheduled basis.
应有适当范围和精度的天平和其它测量设备，可用于生产和控制操作，并应按计划进行校验。
13.4. Equipment and instruments should be thoroughly cleaned on a scheduled basis.
设备和仪器应定期进行彻底清洁。
13.5. Defective equipment and instruments should be removed from operational areas or be clearly labelled as defective in order to prevent use.
有缺陷的设备和仪器应从操作区域移开，或清楚地标记为有缺陷的，以防止误用。
14.物料
Materials
14.1. Materials should be purchased from approved suppliers.
材料应从批准的供应商处购买。
14.2. Materials, identified through risk assessment, should be quarantined immediately after receipt, sampled and tested in accordance with specifications.
通过风险评估识别的材料，应在收到后立即进行隔离，并按照质量标准进行取样和检验。
14.3. Materials released by the quality department and within their shelf life should be used.
应使用质量部门放行的且在有效期内的材料。
14.4. Materials identified through risk assessment should be stored under the appropriate conditions as specified on their labels and in an orderly fashion to permit segregation, stock rotation and a first-expire, first-use rule.
对于通过风险评估识别的材料，应在标签上规定的适当条件下，以有条理的方式存储，以实现区别管理、库存更新和先到期先使用的规则。
14.5. The dispensing of materials for the production of a batch should be done according to a written procedure. Materials should be accurately weighed or measured into clean and properly labelled containers.
用于批生产的材料分配应按照书面程序进行。材料应准确称量或测量，放入干净且贴有标签的容器中。
14.6. No materials used for operations, such as cleaning, the lubrication of equipment and pest control, should come into direct contact with the product. Where possible, such materials should be of a suitable grade (e.g. food grade) to minimize health risks.
勿将用于操作的材料（例如清洁、设备润滑和病虫害防治）直接与产品接触。在可能的情况下，此类材料应采用合适的等级（例如食品等级），以最大程度地降低健康风险。
14.7. Water used should be suitable for its intended use.
使用的水应适合其预期用途。
14.8. Packaging materials should be stored in secure conditions so as to exclude the possibility of unauthorized access.
包装材料应存放在安全的条件下，以防止未经授权的使用。
14.9. Intermediate and bulk products should be kept under appropriate conditions.
中间产品半成品应保持在适当的条件下。
14.10. Finished products should be stored under suitable conditions.
成品应在适当的条件下存储。
14.11. Rejected materials and products should be clearly marked as such and stored separately in restricted areas. They should be handled in an appropriate and timely manner. Whatever action is taken should be approved by authorized personnel and recorded.
拒收的材料和产品应清晰标明，并分别存放在限制区域中。应该以适当和及时的方式处理它们。采取的任何措施均应由授权人员批准并记录。
14.12. Toxic substances and flammable materials should be stored in suitably designed, separate, enclosed containers and, as required, by national legislation. All waste materials should be stored in a safe manner and disposed of at regular intervals to avoid accumulation.
有毒物质和易燃材料应存储在适当设计的单独的密闭容器中，并应根据国家法规进行存储。所有废物均应以安全的方式进行存储，并应定期进行处置，以免积累。
文章来源：PharmLink
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