EU-GMP-附录12：药品生产中电离辐射的应用-英文.doc

Introduction Ionising radiation may be used during the? \o "分类:工艺" manufacturing process?for various purposes including the reduction of bioburden and the sterilisation of? \o "分类:起始物料" starting materials,? \o "分类:包装材料" packaging components?or products and the treatment of? \o "分类:血液制品" blood products.There are two types of irradiation process: Gamma Irradiation from a radioactive source and high energy Electron Irradiation (Beta radiation) from an accelerator.Gamma Irradiation: two different processing modes may be employed:(i) Batch mode: the product is arranged at fixed locations around the radiation source and cannot be loaded or unloaded while the radiation source is exposed.(ii) Continuous mode: an automatic system conveys the products into the radiation cell, past the exposed radiation source along a defined path and at an appropriate speed, and out of the cell.Electron Irradiation: the product is conveyed past a continuous or pulsed beam of high energy electrons (Beta radiation) which is scanned back and forth across the product pathway. Responsibilities 1. Treatment by irradiation may be carried out by the pharmaceutical manufacturer or by an operator of a radiation facility under contract (a “ \o "分类:委托生产" contract manufacturer”)，both of whom must hold an appropriate manufacturing authorisation.2. The pharmaceutical manufacturer bears? \o "分类:职责" responsibility?for the quality of the product including the attainment of the objective of irradiation. The? \o "分类:受托方" contract operator?of the radiation? \o "分类:设施" facility?bears responsibility for ensuring that the dose of radiation required by the manufacturer is delivered to the irradiation? \o "分类:容器" container?(i.e. the outermost? \o "分类:容器" container?in which the products are irradiated).3. The required dose including justified limits will be stated in the marketing authorisation for the product.Dosimetry4. Dosimetry is defined as the measurement of the absorbed dose by the use of dosi