By Jian Liu

Published in: DOC Player

Published on: June 17, 2019

Summary: -The post changes of methods and specifications require thorough evaluation and fully control. -Evaluation and implementation of post approval changes needs to follow internal quality system. -Post approval changes may require regulatory agency’s approval. -During stability testing, thorough evaluation and appropriate process should be in place when test methods and specifications are changed and the updated methods/specifications are implemented.

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