Abstract:
OBJECTIVE To promote the development of the whole pharmaceutical manufacturing industry towards high standards and strict requirements, by discussing the impact of the realization of "two certificates in one"combining Manufacturing Authorization Certificate and the Good Manufacturing Practices(GMP) Certificate on pharmaceutical companies.
METHODS Based on the current status of China's GMP certification system, analyzed the advantages and disadvantages of the "two certificates in one" of pharmaceutical companies, to understand the problem in the process of GMP certification.
RESULTS The "two certificates in one" was beneficial to reduce the burden of enterprises, enable enterprises to continuously comply with GMP production, increase the intensity of drug inspection and improve the efficiency of supervision, strengthen the team of supervisors, improve the self-inspection management system of enterprises and facilitate the merger and reorganization of small and medium-sized enterprises. The disadvantage was that enterprises may relax their learning of GMP, study and management, risk of withdrawal of GMP certificate of pharmaceutical products increased, laws and regulations could not be revised and updated in time, but there were more advantages than disadvantages.
CONCLUSION "Two certificates in one" is more advantageous than disadvantageous.