Q7a问答解读（验证部分）.docVIP

Q7A US Based Training Seminars, 2002Section 12: Process Validation 工艺验证 1. Q. Does Q7A address the need for product-specific Master Plan or the Validation Master Plan? 问：Q7A 指南有没有要求针对产品的主计划或是验证主计划？ A written validation protocol should be established that specifies how validation of a particular process will be conducted. The protocol should be reviewed and approved by the quality unit(s) and other designated units. Q7A doesnt address product-specific or Master Validation plans. Its really the companys judgment what you do with the Master Plan. The Master Plan could be for an Intermediate or