Abstract:
OBJECTIVE To provide reference for drug supervision and industry development in China.
METHODS The GMP inspection deficiencies about buildings and facilities, equipment which were issued by FDA, MHRA, CFDI and Liaoning drug regulatory agency in recent years were analyzed, and the important role of GMP inspection deficiencies in reflecting the hardware level of pharmaceutical enterprises was analyzed from the perspective of deficiency proportion and high frequency deficiencies.
RESULTS & CONCLUSION The gap between China and developed countries in buildings and facilities, equipment is found from the perspective of GMP inspection deficiencies. Suggestions are put forward for the improvement of buildings and facilities, equipment of China's pharmaceutical industry.