EU-GMP 附录一 翻译搞中.docVIP

ANNEX 1 附件1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS 无菌医药产品的生产Principle 原则 The manufacture of sterile products is subject to special requirements in order to minimise risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or