文档介绍：第第1010 节节--药品包装药品包装第第1010 节节--药品包装药品包装 Packaging of Pharmaceuticals the compliance group Stan O’Neill Chapter 3 Chapter 3 第三章第三章 Chapter 3 Chapter 3 第三章第三章? Principle 原则? Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid crosscontamination, build up of dust or dirt and, in general, any adverse effect on the quality of products. ?厂房与设备的选址,设计,建造,改造及维护必须适用于所实施的操作。为避免交叉污染,积灰以及对产品质量不良影响, 厂房和设备的设计和布局必须能最大限度降低发生差错的风险,有便于有效清洁和维护。? Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels. ? 款:厂房应当最好按生产工艺流程及相应洁净级别要求合理布局。 Chapter 3 Chapter 3 第三章第三章 Chapter 3 Chapter 3 第三章第三章? The adequacy of the working and in -process storage space should permit the orderly and logical positioning of equipment and materials so as to minimise the risk of confusion between different medicinal products or their components, to avoid cross -contamination and to minimise the risk of omission or wrong application of any of the manufacturing or control steps ? 款:工作区和中间物料存贮区应有足够的空间,以有序地存放设备和物料,避免不同药品或组分混淆、避免交叉污染、避免制造或质量控制操作发生遗漏或差错。 Chapter 3 Chapter 3 第三章第三章 Chapter 3 Chapter 3 第三章第三章? Premises for the packaging of medicinal products should be specifically designed and laid out so as to avoid mix -ups or cross - contamination. ? 款:用于药品包装的厂房应专门设计和布局,以避免混淆或交叉污染。 Chapter 3 Chapter 3 第三章第三章 Chapter 3 Chapter 3 第三章第三章? Production areas should be well lit, particularly where visual on -line controls are carried out. ? 款:生产区应有足够的照明,特别是产品在线目检区。 Chapter 3 Chapter 3 第三章第三章 Chapter 3 Chapter 3 第三章第三章? Storage Areas 储存区? Storage areas