White paper: China implements GMP certification for pharmaceutical manufacturers

2008-07-18 02:42:34 GMT       2008-07-18 10:42:34 (Beijing Time)       Xinhua English

BEIJING, July 18 (Xinhua) -- China implements Good Manufacturing Practice (GMP) certification for pharmaceutical manufacturers, says a white paper published by the Information Office of the State Council on Friday.

In order to bring drug manufacturing under control, in the late1970s and early 1980s, China introduced the GMP concept, and promulgated the Good Manufacturing Practice for Pharmaceutical Products in 1988, and began to handle applications for GMP certification in 1995, says the white paper.

The present GMP is the 1998 revised edition, says the paper.

Based on its national conditions, and in light of different drug dosage forms, China has implemented GMP standards for pharmaceutical manufacturers step by step, completing GMP certification for manufacturers of blood products in 1998, for manufacturers of sterile powder for injections, sterile freeze-dried powder for injections, large-volume injections and gene engineering products in 2000, and for manufacturers of small-volume injections in 2002, the paper says.

The year 2004 saw the attainment of the goals for the manufacturing of chemical drug substances and all drug preparations according to GMP standards. Manufacturers which failed GMP certification were ordered to stop production, it says.

Since January 1, 2006, the goals for the manufacturing of biological in-vitro diagnostic reagents, medical gas and prepared slices of Chinese crude drugs according to GMP standards have been reached step by step, according to the paper.

Through GMP certification, China has eliminated pharmaceutical enterprises which failed to meet GMP standards, improved quality management among enterprises, and promoted structural adjustment in the pharmaceutical industry, the paper states.

In order to prevent factors that might damage quality at each link of drug distribution and eliminate relevant potential quality risks, China promulgated the Good Supply Practice for Pharmaceutical Products in 2000, says the paper.

The work of GSP certification has gone through three stages: launching certification experimental trials in 2001, handling applications in 2002, and organizing certification in 2003 by the drug regulatory departments in provinces, autonomous regions and municipalities directly under the central government, it says.

Through GSP certification, China's pharmaceutical distributors have made great progress in terms of their overall strength and business conditions, with some unqualified enterprises eliminated, the paper states.

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