GMP文件的编制

近几年，国家对制药企业实施了GMP认证制度，许多企业逐步深化GMP管理，投入了大量的人力、物力、财力来进行GMP硬件改造和进行GMP文件编写。对于一个硬件条件已具备GMP标准，正在准备申请GMP认证的企业来说，编写GMP文件的工作量是巨大的。很多企业刚开始搞GMP认     

编写GMP文件的体会

随着国家对GMP管理工作的加强及企业负责人对药厂实施GMP管理有了深刻的认}只，许多药厂都在为实施GMP管理并准备通过国家GMP认证进行积极努力，而GMP文件的编写便是其中重要的一环。笔者曾有幸编写有了一定体会，愿叙述如下，希望对正准备编写GMP文件的药厂有所帮助。     

制药企业文件在GMP生产管理中的作用

从文件系统的分类入手阐述了文件在GMP生产中的重要作用，说明了制药企业文件管理的作用是明确管理责任，如实反映情况，减少因口头方式交接而产生差错的危险，保证工作人员按文件正确操作，并能积累每批产品的全部资料和数据。     

GMP中"文件管理"

GMP中"文件"是指一切涉及药品生产、管理的书面标准和实施过程中的记录结果."文件"在药品制造的GMP全过程最终都是以"文件"的形式反映的.无论世界卫生组织的GMP,还是欧共体的GMP或我国的GMP,均把"文件"单独列出作为一章,由此可见文件的重要程度.欧共体GMP"文件"一章中,第一句话就概括地指出了文件管理的地位和目的:"良好的文件管理系统是质量保证体系的重要组成部分.     

如何实施GMP才能保证其切实可行

通过建立质量保证体系，制订保障体系运行的相应文件，根据《药品生产质量管理规范》要求设计企业GMP认证自查表并据此制订相应GMP管理文件，然后形成企业GMP管理文件系统，最后推行制订的GMP文件等一系列GMP实施步骤，保证实施的GMP既切实可行．又符合GMP要求。     

制药企业GMP文件生命周期管理调查

目的:为完善制药企业《药品生产质量管理规范》(GMP)文件管理提供参考。方法:介绍笔者提出的GMP文件生命周期管理模型,依据该模型开展调研与实践,分析制药企业GMP文件生命周期管理中存在的问题,并提出相应措施。结果:当前制药企业的GMP文件存在起草缺乏系统性、完整性、可操作性及扩展性,文件审核形式化,文件执行人员培训效果不佳,文件执行不到位和文件处置不当等问题。应依据GMP文件生命周期管理模型,采取顶层设计GMP文件、明确职责和加强文件审批、强化培训管理和提升培训效果、完善奖惩机制和加强文件执行力度、科学存放文件、开展文件的变更控制等措施。结论:建立一套系统、科学、实用的文件管理系统并有效开展GMP文件生命周期管理,对提升制药企业的质量管理水平和促进新版GMP的有效实施具有举足轻重的作用。     

制药企业GMP文件的管理

制药企业GMP文件的管理是企业实施GMP成效的根本保障,GMP文件管理的好坏直接影响企业申请GMP认证的成败,本文根据实际经验,介绍了在制药企业中如何管理GMP文件的一些经验。     

浅析FDA对我公司原料药的GMP现场检查

目的：浅析FDA对原料药的GMP现场检查。方法：针对FDA关于原料药GMP现场检查的重点进行详细论述和分析。结果与结论：企业如果建立了扎实的GMP制度，严格执行美国的CGMP，在实事求是的基础上，充分做好现场和文件准备，就可以成功通过FDA的GMP认证现场检查。     

对药品生产企业实施GMP的调查与思考

目的探索药品生产企业深入贯彻药品GMP,确保生产环节药品质量。方法通过调查,归纳分析当前药品生产企业实施GMP管理中存在的主要问题并提出建议。结果与结论药品生产企业深入贯彻GMP,应进一步解放思想,实现五个转变、做到五个结合、文件修订把握四个基本点、实现文件的八个特性,把GMP的本质要求量化、细化到每一个药品的管理和生产全过程。同时药监部门也要实事求是地解决药品GMP认证现场检查中存在的问题。     

制药企业GMP文件管理中的问题研究

文件作为GMP系统中的＂软件＂,是GMP体系的保证,GMP文件的规范化管理是药品生产企业生产过程规范化管理的前提。本文从制药企业工作中的实际问题出发,探讨企业在GMP文件管理中的常见问题和解决方法。     

Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

The continued globalization of pharmaceutics has increased the demand for companies to know and understand the regulations that exist across the globe. One hurdle facing pharmaceutical and biotechnology companies developing new drug candidates is interpreting the current regulatory guidance documents and industry publications associated with bioanalytical method validation (BMV) from each of the different agencies throughout the world. The objective of this commentary is to provide our opinions on the best practices for reference standards and key reagents, such as metabolites and internal standards used in the support of regulated bioanalysis based on a review of current regulatory guidance documents and industry white papers for BMV.     

我国医疗器械检验机构产品技术要求预评价工作现状、问题和建议

目的：通过对国内主要医疗器械检验机构和审评机构的调研,了解相关文件出台后我国医疗器械检验机构产品技术要求预评价工作现状、存在问题,并提出建议。方法：采用发函调研并回收调查表的模式开展相关基础信息的收集。结果与结论：调查表反馈显示,我国医疗器械检验机构对产品技术要求预评价工作普遍重视,并已按文件要求贯彻实施,但在文件条款执行中遇到一些具体问题,主要可概括为企业、审评机构及检验机构对相关文件理解和执行不统一的问题,以及文件执行后生物学评价开展无规可依的问题。建议相关部门能够出台法规细则,加强对官方机构工作人员和企业双方面的培训,建立畅通的机构间交流机制并加强对医疗器械产品生物学评价的规范化管理。     

Nanotechnology and therapeutic delivery: a drug regulation perspective

Nanotechnology is expected to contribute to the therapeutic delivery field in the coming decade. Although the US FDA has multiple guidance documents in place to deal with novel drug products, nanoparticles may produce issues that have not been previously encountered with small drug molecules. This regulatory focus highlights some current guidance documents and thinking of the FDA as applied to nanoparticles used for therapeutic delivery.     

基本药物目录地方增补品种模式的利弊分析及对策研究

目的:为选择适合我国现阶段国情的基本药物目录制定模式提供参考。方法:在研究国家相关政策和查阅相关文献的基础上,通过分析总结和逻辑推理,对现行的基本药物目录制定所采用的地方增补品种这一模式进行利弊分析。结果与结论:笔者认为,基本药物目录地方增补品种模式的弊明显大于利,不适应现阶段我国国情。建议我国采用多品种无增补模式制定基本药物目录。     

The classification of anxiety disorders

A brief outline of some of the diagnostic systems for classifying the anxiety disorders are presented. This includes historical diagnoses, as well as systems of the recent past and those in current use. Some of the research issues and results leading to these diagnostic systems have been considered, as well as the way that a diagnostic system could have adverse effects in limiting research and the understanding of the anxiety disorders and their interplay, one with another. Finally a revised diagnostic system for the anxiety disorders is introduced, which, it is suggested, will overcome some of the serious criticisms of the current diagnostic systems.     

Summary of Confirmation Cut Point Discussions

A subgroup of AAPS NBC Immunogenicity Workshop attendees met to discuss the current recommendations in white papers and guidance documents, to describe and discuss current practices, and to resolve concerns as to the biologically and statistically appropriate approaches to determining a confirmatory cut point for immunogenicity assays. This is a summary of our discussions and recommendations.     

An analysis tool to investigate theft or tampering of controlled substances

The authors describe a quantitative analysis method to investigate narcotic theft or tampering on a nursing unit. It provides procedure to follow after any suspected tampering or outright theft of controlled substances. Several methods to review all current controlled substance activity for a given nursing unit and their possible relations to the loss are described. In addition several working documents are described to aid in the analysis of the loss.     

History and current state of toxicology in Russia

This paper provides a brief history of toxicology and an overview of current research activities and education in toxicology in Russia. It includes a list of national bodies and research institutes, as well as laws, regulatory documents, and databases in toxicology.     

Critical aspects in reproductive and developmental toxicity testing of environmental chemicals

The process of toxicity testing of environmental chemicals is ruled by a framework of guidelines (OECD, OPPTS, etc.). The present paper will describe the process from the biological tests for environmental chemicals up to potential labelling and will focus on some critical aspects in this cascade of events. It is also the aim of this paper to give an overview of the existing documents and draft documents relevant for this field and available in the internet. Based on the current situation, the following points are discussed as critical issues: life stage considerations and their implications on testing, usefulness of investigations in juvenile animals, requirements for ADME studies, design and endpoints in fertility studies, use and usefulness of developmental milestones, performance of special studies versus one-study-design, considerations on transplacental carcinogenicity and early aging, significance of maternal/parental toxicity, application of triggers to justify studies, inclusion of new endpoints into test guidelines, and test strategies applied. Based on this, the usefulness of risk considerations in the current EU classification system for toxicity to reproduction as well as potency considerations will be discussed and suggestions will be made to improve the basic requirements for chemical testing which have remained relatively unchanged over the past 20 years.     

基于智能供应链视角下药品流通环节的挑战研究

目的：了解现阶段我国药品流通环节智能化研究进展，梳理药品流通环节面临的挑战，提出解决挑战的策略，以期促进我国药品流通环节智能化进程。方法：采用回顾性研究的方法，以“药品供应链”“医药供应链”为关键词，在万方、中国知网数据库检索，经筛选得到39篇文献；运用NoteExpress、Cite Space软件对其进行分类整理。结果与讨论：我国药品流通环节信息技术需要提升，追溯体系待健全；流通企业较分散，物流体系待完善；医疗机构智能化水平弱，药品质量风险高。应推进信息化建设，提高供应链可视度，整合供应链以提高运营效率，早日实现智能药品供应链，完成流通环节的转型升级。