2011年6月上旬WHO发布的技术报告中，包括了一个附件2《制药厂微生物实验室的最佳实践》"WHO good practices for pharmaceutical microbiology laboratories"。
 
自从2009年WHO技术报告中采纳了药厂质量控制实验室最佳实践的修订版本文件后，检查员提出有必要出台一个药厂微生物实验室最佳实践的文件附录文件。为此ＷＨＯ的专家研发了〈药厂微生物实验室最佳实践〉。
 
该文件内容包括有：
 
Ø 1.人员Personnel

Ø 2.环境 Environment -2.1环境设施Premises; 2.2实验定的环境检测 Environmental monitoring in the laboratory; 2.3 清洁、消毒和卫生Cleaning, disinfection and hygiene; 2.4灭菌实验设施 Sterility test facilities

Ø 3. 实验方法的验证Validation of test methods

Ø 4. 设备Equipment - 4.1 设备维护Maintenance of equipment; 4.2 确认Qualification; 4.3 校正、性能确认和使用监测Calibration, performance verification and monitoring of use

Ø 5. 试剂与培养介质Reagents and culture media - 5.1 试剂Reagents; 5.2 培养基Media; 5.3标签Labelling; 5.4传代 Organism resuscitation

Ø 6. 参比标准物和标准菌株Reference materials and reference cultures- 6.1 内部标准和药典标准品International standards and pharmacopoeial reference substances; 6.2标准菌株Reference cultures

Ø 7.取样Sampling

Ø 8.样品处理与确认Sample handling and identification

Ø 9. 污染废物的处理Disposal of contaminated waste

Ø 10. 实验结果的质量保证和质量控制Quality assurance of results and quality control of performance - 10.1 内部质量控制Internal quality control

Ø 11.实验程序Testing procedures

Ø 12.实验报告Test reports

附件包括内容有：
 
Ø 附件1操作区域实例Examples of zones in which operations could be carried out
 
Ø 附件2 设备维护实例 Examples of maintenance of equipment
 
Ø 附件3 校正检查表实例和不同设备的校正间隔Examples of calibration checks and intervals for different laboratory equipment
 
Ø 附件4 设备确认与监测的实例Examples of equipment qualification and monitoring
 
Ø 附件5 标准菌株使用的通用要求General use of reference cultures
 
这个指南适用于下列所有相关的微生物实验室
 无菌实验sterility testing; 
微生物限度检测，微生物分离和鉴定，细菌内毒素检测detection, isolation, enumeration and identification of microorganisms(bacteria, yeast and moulds) and testing for bacterial endotoxins in different materials (e.g. starting materials, water), products, surfaces,garments and the environment; and
 效价测定assay using microorganisms as part of the test system.