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“人、机、料、法、环”是质量管理学中的重要概念，简称质量的5要素。“人”指人员，“机”指设备，“料”指物料，“法”指方法，“环”指环境。通过实践我们发现，“人、机、料、法、环”与兽药GMP之间是密不可分的，把“人、机、料、法、环”的概念融入到兽药GMP管理体系中来，对我们进一步认识GMP、掌握GMP、运行GMP有着很大的帮助。下面，我们进一步阐述两者之间的关系。
一、从GMP的12个要素构成来看
“人”即指机构与人员，“机”指生产设备、检验设备、“料”指物料，“法”指生产管理、质量管理文件，“环”指厂房与设备、卫生等。这5个要素构成了GMP的基本要素。
对人的要求主要是指人的学历、专业知识、生产经验、培训情况、上岗证书等；对设备的要求主要是指生产、检验、空调净化、制水设备等是否齐全，设备性能、材质、设计、安装是否符合要求，计量仪器设备是否检定等；对物料的要求主要是指指原辅料、包材、标签等是否符和相关标准，储存条件及期限是否符和要求，是否进行供应商审计，收发是否计数等；对方法的要求主要是指生产管理、质量管理文件是否齐全，制度、规程、标准、记录是否完整，内容是否符合要求等；对环境的要求主要包括厂区周围、厂区、车间、仓库、实验室的环境、布局、卫生、环境控制、防污染措施、厂房、设备、器具的清洁，人员、物料进入生产区域的清洁措施和卫生要求，生产结束后的清场等。
二、从岗位操作的基本要求来看
每一个企业在对员工的培训中总感到岗位操作培训是一个难点，工人总记不住繁琐的规定、程序及要求等。其实，对企业员工的岗位培训用“人、机、料、法、环”来引导，用处就更大了。每一个员工在生产、检验操作过程中都应牢记“人、机、料、法、环”这5个要素。以生产操作岗位为例：“人”即指员工应如何进入生产岗位；“机”即指设备应处于什么状态；“料”即指生产过程中的原辅料、半成品、成品、包材、标签等是否符合要求；“法”即指岗位生产操作应依据什么进行；“环”即指生产环境，生产前、中、后均应检查环境是否符合要求。
在GMP检查验收的人员考核过程中，专家们经常会问到一个问题—你在生产前首先应该做什么？只要记住“人、机、料、法、环”这5要素，这个问题应该是再容易不过了。其它诸如“设备坏了如何进行维修”、“仓库进了批原料如何去抽样”、“简述你岗位操作程序”等等问题，都可以迎刃而解了。
总之，我们把质量管理学中“人、机、料、法、环”的重要概念引入到兽药GMP管理体系中来，便于大家记忆和理解，对我们深入认识、掌握和运行GMP有着重要的意义。
GMP：Good Manufacturing Practice for drugs
"Person,machine, anticipate, method,wreath" is in the function in the monster medicine GMP
"Person,machine, anticipate, method,wreath" is the quality management to learn medium important concept, 5 main factorses of the brief name quality."Person" points a personnel, "machine" points an equipments, "anticipate"ing to point a material, "method" points a method, "wreath" points environment.Pass to practice our detection, "person,machine, anticipate, method,wreath" and of the monster medicine GMP are inseparable, integrating the concept of"person,machine, anticipate, method,wreath" to the monster medicine GMP management system, knowing GMP,control GMP and circulating GMP to have a very great help further to us.Underneath, we elaborate both further of relation.
A,constituted from GMP 12 main factors to see
"Person" points organization and personnel namely, "machine" points to produce an equipments,examine an equipments and"anticipate" to point a material, "method" points the production control,quality management document, "wreath" points the factory premises and equipments,hygiene etc..This 5 main factors constituted GMP an essential element.
Mainly mean to person's request the person's educational background,professional knowledge,produce experience and train a circumstance,last certificate etc.;Mainly mean to the request of the equipments production,examination,air condition decontamination,make the water equipments whether etc. is well-found or not, equipments function,material,design,install whether meet a request, calculate whether the instrument equipments examine or not etc.;Mainly mean to point to the request of the material to assist to anticipate,wrap material,label...etc. at first whether sign with related standard, store the condition and term whether sign and request, whether carry on the supplier audit, receive and dispatch whether count etc.;The request of the other party method mainly means the production control,quality manages whether document is well-found or not, system,rules distance,standard,record whether complete, whether contents meets to request or not etc.;Mainly include the environment of the factory area surroundings,factory area,car,warehouse,laboratory to the request of the environment,layout,hygiene,environment control,defend pollution measure,factory premises,equipments,tool of sweep, the personnel,material enters production district to sweep the measure and hygiene request, after producing be over of pure field etc..
Two,basic request operated from the post to see
Each business enterprise always feels the post operation training be a crux in the rightness the employee's training, the worker always records to live tedious provision,procedure and request not etc..Guide with"person,machine, anticipate, method,wreath" to the business enterprise employee's post training in fact, use larger.Each employee should keep firmly in mind this 5 main factors of"person,machine, anticipate, method,wreath" in the production, the examination operation process.Take producing operation post as an example:"Person" points employee namely to enter to produce a post what if;"Machine"'s pointing an equipments namely should be placed in what appearance;"Anticipate" to point a production line namely in of assist to anticipate at first,semi-processed goods,finished product,wrap whether material,label...etc. meets a request or not;"Method"'s pointing the post production operation namely should basis what carry on;"Wreath" points to produce environment namely, before produce,medium,the empress all should check whether environment meet a request or not.
In the GMP check check before acceptance of the personnel investigate the process, the experts usually would inquire about a problem-what should you do first before production?As long as remember this 5 main factors of"person,machine, anticipate, method,wreath", this problem should be again easy however.Other such as"the equipments is out of order how carry on maintain","the warehouse entered to criticize raw material how go to draw samples","JIAN3 SHU4 NI3 the post operation procedure" etc. problem, can solve problems with the greatest ease.
In fine, we learn the quality management to lead to go into the monster medicine GMP management system in the important concept of"person,machine, anticipate, method,wreath", easy to everyone memory and comprehension is thorough to us understanding,control with circulate GMP to have important meaning.