According to good manufacturing practices,
Article 1 In order to standardize the quality management of pharmaceutical production, this specification is formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC).
Article 2 An enterprise shall establish a drug quality management system. The system should cover all factors affecting the quality of drugs, including all organized and planned activities, to ensure that the quality of drugs meets the intended use.
Article 3 As a part of the quality management system, this specification is the basic requirement of drug production management and quality control, aiming at minimizing the risks of pollution, cross-contamination, confusion and errors in the process of drug production, and ensuring the sustained and stable production of drugs that meet the expected use and registration requirements.
Extended data:
The World Health Organization began to organize the formulation of drug GMP in the mid-1960s, and China began to implement it in the 1980s. China's GMP was promulgated in 1988 and first revised in 1992.
Over the past ten years, China has made some achievements in promoting drug GMP, and a number of pharmaceutical enterprises (workshops) have successively passed drug GMP certification and reached the standard, which has promoted the improvement of production and quality level in the pharmaceutical industry. But overall, the implementation of drug GMP is not enough, and some contents of drug GMP need to be revised accordingly.
Since the establishment of 19/8/998, the State Administration of Pharmaceutical Products has attached great importance to the revision of drug GMP, held several forums to listen to opinions from all sides, especially pharmaceutical manufacturers, and organized relevant experts to carry out the revision.
Good manufacturing practice (revised 1998) has been issued by Decree No.9 of the State Administration of Pharmaceutical Products, and has been implemented since August, 2009. The good manufacturing practice (20 10 Revision) (hereinafter referred to as the new version of drug GMP) was formally implemented in March, 20 1 1 year.
Baidu Encyclopedia-Good Manufacturing Practices