7.29.If it becomes necessary to change theuse-by date, an additional label should be affixed to the investigationalmedicinal product. This additional label should state the new use-by date andrepeat the batch number. This labelling activity should be performed inaccordance with GMPprinciples, standa...
11.4. Where activities are outsourced tocontract facilities, the contract must then clearly state, inter alia, theresponsibilities of each party, compliance with GMP or of this guideline, andthat the product(s) to be manufactured...
5. For anadditional FPP manufacturing site, a minor variation may be submitted if the proposed site has been inspected and found GMP compliant by WHO or an SRA inthe last three years (variation no.28). Should a major variation be used if the GMP inspection for the proposed site was conduc...
who验证指南2016年版.docx,1. INTRODUCTION 简介 1.1 Validation is an essential part of good practices including good manufacturing practices (GMP) (4) and good clinical practices (GCP). It is therefore an element of the pharmaceutical quality system. Valid
一、WHO预认证简介 •WHO预认证的目的 –增加质控实验室的数量：符合药品检验的相关标准并受委托为联合国机构进行药品检验；–促进发展中国家的国家质控实验室的能力建设 技术支持培训指导原则 一、WHO预认证简介 •2004年WHO建立预认证程序 –与联合国儿童基金会(UNICEF)、联合国人口基金(UNFPA...
related materials (WHO TRS, No. 929, Annex 5)一、WHO预认证简介二、二、WHO GPCL简介简介三、中检院化学药品实验室预认证情况四、WHO预认证及药品抽验相关实验室区域间研讨会五、全国药检系统质量管理体系建设 适用于任何药品质控实验室(国家实验室、商业实验室、非政府实验室等) 与WHO GMP和ISO 17025:2005...
近年,在 GMP、GCP 和 GLP 检查中,数据完整性、文件记录管理规范性方面的缺陷数量大大上升。可能的原因大致包括(1)太过依赖人员操作,(2)使用了未进行恰当管理和验证的计算机化系统,以及(3)未充分审核和管理原始数据与记录。 1.3. Quality risk management (QRM), control strategies and sound scientific principles...
Design qualification: The process of obtaining and documenting evidence that the premises, equipment and supporting systems and processes have been designed in accordance with the requirements for Good 1 Manufacturing Practices (GMP) . Deviation: For IQ: Any discrepancy between the installation ...
审计追踪是含有 GMP 记录创建、修改或删除相关动作信息的元数据表。审计追踪提供生命周期详细情况的安全记录,如电子或纸质记录中信息的创建、增加、删除或修改,而不会妨碍或改写原始记录。审计追踪有利于重建此类与记录(无论使用何种介质)有关事件的历史,包括动作...
洛施德GMP咨询 - WHO第961号技术报告附录9(时间温度敏感的药物贮运指南):温控存贮区的确认.pdf,SoltorisManagement Consultants, Inc. 洛施德企业管理咨询(上海)有限公司 Qualification of temperature-controlled storage areas Technical supplement to WHO Technical