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什么是GMP标准与GMP车间

文章作者:发布时间:2019-09-19 05:32:41浏览次数:

小易为你介绍一下什么是GMP标准与GMP车间。

GMP标准是一套适用于制药、食品等行业的强制性标准,要求净化工程企业从原料、人员、设施设备、生产过程、包装运输、质量控制等方面按国家有关法规达到卫生质量要求,形成一套可操作的作业规范帮助企业改善企业卫生环境,及时发现生产过程中存在的问题,加以改善。简要的说,GMP要求生产企业应具备良好的生产设备,合理的生产过程,完善的质量管理和严格的检测系统,确保最终产品的质量符合法规要求。

GMP车间,净化厂房墙、顶板材一般多采用50mm厚的夹芯彩钢板制造,其特点为美观、刚性强。圆弧墙角、门、窗框等一般采用专用氧化铝型材制造。

GMP车间为了防止交叉污染,清扫净化车间设施的工具均应按产品特点、工艺要求、空气洁净度级别的不同分别专用,垃圾装入防尘袋中拿出。

GMP车间的清扫必须在上下班前、生产工艺操作结束后进行;清扫要在净化车间空调系统运行中进行;清扫工作结束后,净化空调系统要继续运行,直到恢复规定的洁净级别为止,开机运行时间一般不短于该GMP车间的自净时间。使用的消毒剂要定期更换,以防止微生物产生耐药性。大的物件搬进车间时,先要在一般环境中用真空吸尘器进行初步的吸尘净化,然后再准进入净化车间内,用洁净室真空吸尘器或擦拭方法进一步处理;在GMP车间净化系统停止运行期间,不允许把大的物件搬进净化车间。

GMP净化车间要进行消毒灭菌,可采用干热灭菌、湿热灭菌、辐射灭菌、气体灭菌、消毒剂消毒。

英文:

Xiaoyi will introduce you to GMP standard and GMP workshop.

GMP standard is a set of mandatory standards applicable to pharmaceutical, food and other industries. It requires purifying engineering enterprises to meet the requirements of hygienic quality in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control and other aspects in accordance with relevant national regulations, and to form a set of operational norms to help enterprises improve enterprise hygiene. Environment, timely detection of problems in the production process, to improve. Briefly speaking, GMP requires enterprises to have good production equipment, reasonable production process, perfect quality management and strict inspection system to ensure that the quality of final products meets the requirements of regulations.

In GMP workshop, the wall and roof of purification workshop are usually made of 50 mm thick sandwich color steel plate, which is characterized by beautiful appearance and strong rigidity. Arc corner, doors, window frames, etc. are generally made of special alumina profiles.

In order to prevent cross-contamination in GMP workshop, tools for cleaning and purifying workshop facilities should be specially designed according to product characteristics, process requirements and air cleanliness level, and garbage should be put into dustproof bags and taken out.

Cleaning in GMP workshop must be carried out before commuting and after the end of production process operation; cleaning should be carried out in the operation of air conditioning system in purification workshop; after cleaning, the air conditioning system should continue to operate until the specified clean level is restored, and the start-up time is generally not shorter than the self-cleaning time of GMP workshop. The disinfectants used should be replaced regularly to prevent microorganisms from developing resistance. When large items are moved into the workshop, they should be cleaned by vacuum cleaner in general environment first, and then allowed to enter the purification workshop. They should be further treated by vacuum cleaner or wiping method in the clean room. During the stop of operation of the purification system in GMP workshop, large items are not allowed to be moved into the purification workshop.

GMP purification workshop to carry out disinfection and sterilization, can use dry heat sterilization, wet heat sterilization, radiation sterilization, gas sterilization, disinfectant disinfection.