Section 5 Therapeutic Area Topics 治疗领域主题[译注:未翻译,有需要时单独查阅]Section 6 terminology 术语6.1 General 综述Common dictionaries should be used across all clinical studies and throughout the submission for each of the following: adverse events, concomitant medications, procedures, indications, ...
The Agency believes "flexibility of the cGMP regulations should enable manufacturers to implement quality systems in forms that are appropriate for their specific operations." Therefore, they do not tell manufacturers how to write their procedures in order to compl...
CDRH 与美国测试和材料协会(American Society of Testing and Materials,ASTM)、国际标准化组 织(International Organization for Standardization, ISO)一起,采用实验和计算固体力学的方法来研 究现有的和新材料相关的工程力学问题,以期为 FDA监管工作制订各类标准和指导文件。研究组考 察各类传统的工程材料(如金属和高...
Standard operating procedures (SOPs) Qualification procedures for equipment and materials Qualification and training of people performing work Validation of processes and test methods Audits QMS often implements the Plan-Do-Check-Action (PDCA) cycle: Plan: In this phase, a company sets g...
The estimate of inoculum concentration may be obtained by turbidimetric procedures for the challenge microorganisms and later confirmed by plate count. 接种物浓度的估计值可以通过挑战微生物的比浊法获得,然后通过平板计数确认。 Refrigerate the suspension if not used within 2 hours at 2-8°C. 如果2 ...
Companies engaged in medical device activities are required to establish appropriate procedures for mandatory internal QMS/quality audits to check the ongoing compliance of each medical device company facility. If a company fails to conduct an appropriate internal audit according to the company procedure ...
需要金币:*** 金币(10金币=人民币1元) 美国FDA 指导原则 C反应蛋白(CRP)、高敏C反应蛋白(HsCRP)和心脏C反应分析的评审标准(PDF格式) 英文原版.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Guidance for Industry and FDA Staff Review Criteria for Assessment of C-Reactive Protein ...
FDA指导文件-医疗设备中现成软件的使用Off-The-Shelf-Guidance_0.pdf,Contains Nonbinding Recommendations Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on August 11, 2023. Document o
4.1.6SDIXshalldocumentproceduresforvalidationofcomputersoftwareusedintheQuality ManagementSystemasperValidationMasterPlanSOPG5807.Suchsoftwareapplicationsshall bevalidatedpriortoinitialuseand,asappropriate,afterchangestosuchsoftwareorapplication. Thespecificapproachandactivitiesassociatedwithsoftwarevalidationandrevalidationshall...
Association for the Advancement of Medical Instrumentation (AAMI). Sterilization of health care products- Biological indicators- Part 4: Biological indicators for dry heat sterilization processes. ANSI/AAMI/ISO ST11138-4:2006. ISO. 2006. International Organization for Standardization (ISO). Sterilization...