Parametric release can be authorised if the data demonstrating correct processing of the batch provides sufficient assurance, on its own, that the process designed and validated to ensure the sterility of the product has been delivered.

• 达到以下条件后可以授权给参数放行：显示正确处理这一批的数据能独立提供足够的保证；以上所述的处理是设计和验证好的；以确保无菌产品已经送达.