医用气体制造.docVIP

医用气体的制造Table?of?Contents目录1.?Principle………………………………………………………………………………3原则2.?Personnel……………………………………………………………………………3人员管理3.?Premises?and?equipment………………………………………………………………3厂房和设备4.?Documentation ……………………………………………………………………….4文件管理5.?Production……………………………………………………………………………5生产管理6.?Quality?control………………………………………………………………………7质量控制7.?Storage?and?release…………………………………………………………………8储存和放行Glossary…………………………………………………………………………………9术语表1.Principle原则This?annex?deals?with?industrial?manufacturing?of?medicinal?gases,?which?is?a?specialised?industrial?process?not?normally?undertaken?by?pharmaceutical?companies.?It?does?not?cover?manufacturing?and?handling?of?medicinal?gases?in?hospitals,?which?will?be?subject?to?national?legislation.?However?relevant?parts?of?this?annex?may?be?used?as?a?basis?for?such?activities.本附件适用于医用气体的工业制造，这是一个特殊的工业领域而通常不是医药企业的工作。此处不包括医用气体在医院中的制造和操作，其控制另有法律规定，但本附件的相关部分可作为参考。The?manufacture?of?medicinal?gases?is?generally?carried?out?in?closed?equipment.?Consequently,?environmental?contamination?of?the?product?is?minimal.?However,?there?is?a?risk?of?cross-contamination?with?other?gases.通常，医用气体的工业制造的过程是在密闭的设备中进行，因此，环境对产品的污染的可能性较小。但是，存在与其他气体的交叉污染的风险。Manufacture?of?medicinal?gases?should?comply?with?the?basic?requirements?of?GMP,?with?applicable?annexes,?Pharmacopoeial?standards?and?the?following?detailed?guidelines.医用气体的工业制造必须按GMP的基本要求及相应的附件、药典标准和下述具体的原则。2.?Personnel?人员的管理2.1.?The?qualified?person?responsible?for?release?of?medicinal?gases?should?have?a?thorough?knowledge?of?the?production?and?control?of?medicinal?gases.一个合格的负责医用气体放行的人员必须通晓医用气体制造和控制的知识。2.2.?All?personnel?involved?in?the?manufacture?of?medicinal?gases?should?understand?the?GMP?requirements?relevant?to?medicinal?gases?and?should?be?aware?of?the?critically?important?aspects?and?potential?hazards?for?patients?from?products?in?the?form?of?medicinal?gases.所有参与医用气体生产的人员必须理解GMP中关于医用气体的规定，且知道其中最关键的控制规程和明白所生产的产品在病人使用时可能的风险。3.?Premises?and?equipment?厂房和设备3.1.?Premises?厂房3.1.1.?Medicinal?