什么是药品GMP标准规范与GMP洁净车间

              药品生产质量管理规范（GMP）是针对药品、食品等领域制定的一系列强制性质量标准。这些规范要求涉及净化工程的企业在原材料获取、员工操作、设施布局、生产流程、产品包装及运输、质量监控等多个方面，都必须遵守国家相关法律法规，并达到卫生与质量的标准。GMP的目的是为了构建一套实际可行的操作规程，以此来提升企业的卫生环境，及时识别并改进生产过程中的问题。简而言之，GMP强调企业应拥有适宜的生产设施、合理的生产流程、完备的质量管理体系以及严格的质量检测机制，以保证产品质量符合法规标准。

                   在GMP净化车间中，墙壁和天花板通常由厚度为50毫米的彩色夹心钢板构成，这种材料不仅外观美观，而且具有很高的刚性。车间内的圆弧墙角、门、窗框等，通常选用高质量的氧化铝型材制成。

                 为了避免交叉污染，GMP车间内清洁设施的工具都应根据产品的特性、工艺需求和空气清洁度级别进行专门配置，并且废弃物应被装入防尘袋中适当处理。

                 GMP车间的清洁工作通常安排在员工上下班前后，以及生产操作完成后进行。清洁过程需要在净化空调系统运作中进行，以确保环境清洁度的恢复。清洁完成后，净化空调系统应继续运行直到空间达到规定的清洁标准，运行时间通常不少于车间的自净时间。使用的消毒剂应定期替换，以防微生物对其产生抗性。在将大型物件移入车间前，应先在一般环境下使用真空吸尘器进行初步清洁，之后才能搬入净化车间内，并使用洁净室专用的真空吸尘器或擦拭法进行进一步清洁。当GMP车间的净化系统暂停运行时，应避免将大型物件移入。

                在执行GMP净化车间的消毒灭菌工作时，星源洁净可以采用多种方法，包括干热灭菌、湿热灭菌、辐射灭菌、气体灭菌以及使用消毒剂。这些方法能够有效地消除潜在的微生物污染，保证生产环境的洁净安全。

英文：

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.