EU GMP ANNEX 1MANUFACTURE OF STERILE MEDICINAL PRODUCTS（中英文对照） Principle原则The manufacture of sterile products is subject to special requirements in order to minimize 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
