Abstract: OBJECTIVE To find the common problems in the validation of cool warehouse by the pharmaceutical trading enterprise, and find out how to solve them, so as to help the pharmaceutical trading enterprise to grasp the key elements in the validation of cool warehouse. METHODS According to the relevant regulations, to analyze the relevant problems in the validation of cool warehouse by the pharmaceutical trading enterprise at the present stage, and found out the solutions to these problems. RESULTS Analyzed many key problems existing in the validation of cool warehouse by the pharmaceutical trading enterprises at the present stage, and clarifing the validation ideas, so as to help the enterprises to further understand the validation management. CONCLUSION Implement the validation of the cool warehouse perfectly can promote the substantial development of the validation management of pharmaceutical trading enterprises.