【摘要】：研究制藥企業(yè)GMP設(shè)備預(yù)防性維護(hù)的具體途徑和方法。利用系統(tǒng)影響性評估和部件關(guān)鍵性評估等評估工具對設(shè)備系統(tǒng)進(jìn)行分類、分級,制定分層次的具體維護(hù)計(jì)劃,并在工作中進(jìn)行PDCA循環(huán)。通過評估可將設(shè)備分為關(guān)鍵設(shè)備、重要設(shè)備和次要設(shè)備,各設(shè)備中的部件可分為關(guān)鍵和非關(guān)鍵兩個(gè)等級。對關(guān)鍵設(shè)備的關(guān)鍵部件進(jìn)行全面維護(hù),對關(guān)鍵設(shè)備非關(guān)鍵部件以及重要設(shè)備關(guān)鍵部件進(jìn)行重點(diǎn)維護(hù),對重要設(shè)備非關(guān)鍵部件和次要設(shè)備僅需進(jìn)行日常維護(hù),并進(jìn)行PDCA循環(huán),提高設(shè)備管理GMP水平。
[Abstract]:The specific ways and methods of preventive maintenance of GMP equipment in pharmaceutical enterprises are studied. The equipment system is classified and graded by means of system impact assessment and component critical evaluation, and specific maintenance plans are drawn up at different levels, and PDCA cycles are carried out in the work. The equipment can be classified into key equipment, important equipment and secondary equipment through evaluation. The components in each equipment can be divided into two levels: critical and non-critical. Complete maintenance of critical components of critical equipment, focus maintenance of critical equipment non-critical components and critical equipment critical components, routine maintenance of critical equipment non-critical components and secondary equipment, and PDCA cycling. Improve equipment management GMP level.
【作者單位】： 中國藥科大學(xué)國際醫(yī)藥商學(xué)院;
【分類號(hào)】：R95

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