Comparison and analysis of Chinas national criterion GMP(1998) and EU criterion GMP(2005)(1)

Comprises in details the construction and facilities in pharmaceutical workshop between the two versions of good manufacturing practice. Considers that many quality problems happened in the course of medicine manufacture are due to some well-known courses, as well as design, construction, detection, management and maintenance, etc, rather than the so-called lower criterion of Chinas GMP(1998).