Inspectional Guidance-Microbiological Issues for Inspection of Pharmaceutical Laboratories
1.Finished product testing using USP or Non-compendia method成品检测采用USP或非药典方法
Sterility, Bacterial endotoxin, Microbial limits test: specified microorganisms and enumeration, Antimicrobial- effectiveness test, Bioburden determination, water quality control testing; review all original test results
无菌检测，细菌内毒素，微生物限度检测：控制菌和计数，抗菌效力测试，生物负载测试，水质控制测试；审查所有原始测试结果
2. Method Suitability (Sterility), Preparatory test (Bacterial endotoxin), Validation of method used for bioburden and water analysis
方法适用性（无菌测试），预实验（细菌内毒素），生物负载和水分析的分析方法验证。
3. Reagents and medium- proper storage, expiration date activity, and growth promotion
4. Equipment and Instrument- (Steritest, manifold, Automated/Molecular identification system, Vitek, etc) isolator & bio-decontamination system calibration, maintenance, validation- IQ, OQ, PQ
设备和仪器-（无菌的、多管的、自动化的分子鉴定系统，梅里埃生物鉴定仪等）隔离器和灭菌系统校准、维护，验证——安装确认、运行确认、性能确认
5. Sterility testing area design, operational procedures, monitoring, aseptic technique, gowning procedures, proper sample container disinfection, surface/air monitoring, HEPA filter certification, etc
无菌检查区域设计、操作程序、监控、无菌操作技术、防毒程序、正确的样品容器消毒、表面空气监控、HEPA过滤器证书等
6. Method description, modifications, and verification along with recording of sample results and appropriate review and evaluation by management
方法描述，修订，验证并记录结果和管理者适当的复核和评估。
7. Qualifications, training and identification of the personnel conducting each step of the analysis
8. Qualification and training of management to critically review data and interpret its significance (Risk Assessment)
管理人员的资格和培训，严谨的审查数据并解释其重要性(风险评估)
9. Microbial standards set for raw material, finished product, water bioburden, and EM for analytical areas
微生物标准设定：原料药、成品、水生物负载和分析区域的环境监控
10. Integrity and accuracy of the laboratory information management system (LIMS) for microbiology data entry, review and approval Selection, handling, and storage of Biological Indicators (BIs)
实验室信息管理系统（LIMS）的完整性和准确性：微生物数据录入、复核、批准、操作和生物指示剂的储存
11. Private (contract) testing laboratory quality agreements, data review, and associated problems; Have there been any changes in contract labs and why?
合同实验室的质量协议、数据审核及相关问题;合同实验室有什么变更吗?为什么？
12. Proper use and control for In-vitro diagnostic test kits, Positive and negative controls, Interpretation and reliability of results
正确使用和控制体外诊断试剂，阳性对照和阴性对照，解释和结果的可靠性
13. Risk assessment of microbiological results for non-sterile products
14. Request a list of the entire laboratory’s Microbiological Data Deviations (OOS/OOL results) and Corrective Action Preventative Actions (CAPA) ( since last FDA on-site inspection)
要求提供整个实验室的微生物数据偏差（OOSOOL结果）清单和纠偏预防措施（从上次FDA现场审计开始）
15. Stability Testing – sample storage conditions, missed sampling dates, etc.
本文来自 Pharmaceutical Microbiology Manual2014
免责声明：上述内容仅供交流学习使用，对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。仅作参考，并请各位自行承担全部责任。版权归原作者所有，如遇版权问题请联系小编删除。
原文始发于微信公众号（药品微生物检测）：Inspectional Guidance 1-药品实验室微生物问题调查
