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什么是GMP標準與GMP車間

文章作者:發布時間:2019-09-19 05:32:41瀏覽次數:

小易為你介紹一下什么是GMP標準與GMP車間。

GMP標準是一套適用于制藥、食品等行業的強制性標準,要求凈化工程企業從原料、人員、設施設備、生產過程、包裝運輸、質量控制等方面按國家有關法規達到衛生質量要求,形成一套可操作的作業規范幫助企業改善企業衛生環境,及時發現生產過程中存在的問題,加以改善。簡要的說,GMP要求生產企業應具備良好的生產設備,合理的生產過程,完善的質量管理和嚴格的檢測系統,確保最終產品的質量符合法規要求。

GMP車間,凈化廠房墻、頂板材一般多采用50mm厚的夾芯彩鋼板制造,其特點為美觀、剛性強。圓弧墻角、門、窗框等一般采用專用氧化鋁型材制造。

GMP車間為了防止交叉污染,清掃凈化車間設施的工具均應按產品特點、工藝要求、空氣潔凈度級別的不同分別專用,垃圾裝入防塵袋中拿出。

GMP車間的清掃必須在上下班前、生產工藝操作結束后進行;清掃要在凈化車間空調系統運行中進行;清掃工作結束后,凈化空調系統要繼續運行,直到恢復規定的潔凈級別為止,開機運行時間一般不短于該GMP車間的自凈時間。使用的消毒劑要定期更換,以防止微生物產生耐藥性。大的物件搬進車間時,先要在一般環境中用真空吸塵器進行初步的吸塵凈化,然后再準進入凈化車間內,用潔凈室真空吸塵器或擦拭方法進一步處理;在GMP車間凈化系統停止運行期間,不允許把大的物件搬進凈化車間。

GMP凈化車間要進行消毒滅菌,可采用干熱滅菌、濕熱滅菌、輻射滅菌、氣體滅菌、消毒劑消毒。

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.


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