testing different samples until the desired passing result is obtained). This practice, also referred to as testing into compliance, is not consistent with CGMP (see the guidance for industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical...
Lecture 2: Apply Statistics to Specication Setting Setting appropriate product specications Determine FDA requirements for OOS results Determine how to best investigate OOS results Introduction to Interval Estimation Condence Interval Tolerance Interval Outlier A...
Unless otherwise justified, process water should, at a minimum, meet World Health 除非有其它理由,工艺用水最低限度应当符合世界卫生组织(WHO)的饮用水质量 Organization (WHO) guidelines for drinking (portable) water quality. 指南。 If drinking (portable) water is insufficient to ensure API quality and...
举例来说，GMP导言是FDA在出台GMP法规时，对此前征集的企业意见和问题所作出的正式回答；FDA出台过固体制剂、水系统、实验室等等诸多检查手册，指导检查员检查哪些内容，这就相当于解释了具体有哪些要求；FDA出台过诸多指南文件，内容覆盖GMP的方方面面，例如工艺验证指南、实验室超标结果(OOS)处理的指南、无菌操作指南、...
60、alinformation concerningtheinspectionofmicrobiologicallaboratories.12.SAMPLINGSampleswillbecollectedonpre-approvalinspections.Followthesampling guidelinesinCP7346.832,PartIII,pages5and6.13. LABORATORYRECORDSANDDOCUMENTATIONReviewpersonalanalyticalnotebookskeptbytheanalystsinthelaboratory andcomparet 61、hemwiththeworksheet...
Principles for Clinical Evaluation of New Antihypertensive Drugs 新抗高血压药物的临床评价原则 E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价 Multidisciplinary Guidelines 多学科...
Title 21 CFR Part 11, an FDA compliance guideline, specifies the standards for evaluating the trustworthiness of electronic records and electronic signatures.
to be produced but if it is created or collected, it is recommended to be in the TMF. Since the industry often uses unique names, alternate names (as relevant) and descriptions are supplied for each artifact. If the artifact is referenced in the ICH Guidelines, this information is captured...
工业指南 工艺验证:一般原则与惯例 指南草案 本指南文件仅为征求意见之目的而发布 关于本文件草案的意见和建议应当于本草案在联邦公报(Federal Register)上的通告发布之日起 60 天内提交。相关意见提交到以下地址: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 1061...
若要判定检测结果无效并不考虑作为批次符合性标准的判定,必须有一个有效的、有据可查的、科学合理上的理由(见参见§§8 211.160(b)、第211 188、211. 192 和 212.71(b)和《FDA行业指南:OOS调查》。即使检验结果在科学合理调查的基础上被判定为无效, 提供给质量部门的完整CGMP批记录仍需要包含初始的 (无效) ...