GMP偏差处理中英文要点.pdfVIP

1. PURPOSE 目的 Whenever a product, material or system fails to meet the specifications or in the event of a failure to comply with relevant documentation or regulatory requirements, an appropriate investigation must be undertaken, the cause(s) identified and the necessary corrective actions taken 当产品、 物料或系统不符合质量标准要求或某事件不符合相关文件或法规要求时， 必须进行适当 的调查，查明原因并采取必要的改正措施。 2. SCOPE 范围 This SOP covers all failures and unplanned incidents related to Chemical components, Packaging materials, Drug Products, Processes, Systems, Equ