" the tightest in the history " The new norm keeps up with European Union's standard The pharmacy industry shuffles big

" the tightest in the history " The new norm keeps up with European Union's standard The pharmacy industry shuffles big
February 12,>(hereafter referred to as " New GMP " )Went through it after revising in 5, soliciting the opinion publicly twice, opened veils at last, issue formally, will implement formally since March 1, 2011.
National the intersection of Bureau of Drugs Supervision and medicines supervise the intersection of the department and relevant director, say, the new norm has raised the trade threshold greatly safely, may make the whole country at least 500, manage weak medium and small pharmacy enterprises to close down. But meanwhile, new implementation of GMP too expected to improve our country, have the intersection of medicines and lower in production concentration degree at the whole manufacturing enterprise now, such questions as independent innovation ability is insufficient and the medicines incident is frequent. It and what European Union kept up with is high-standard, create the condition in order that the medical enterprises of our country's advantage enlarged strengthening, to European Union exit even more.
The old standard is implemented for more than 10 years and already fallen behind " The tightest in the history " The new norm keeps up with European Union's standard
" GMP" English abbreviation of Good ManufacturingPractice, namely " fine to make the standard " Its meaning. GMP is that one kind especially pays attention to implementing the safe independence management system to product quality and hygiene in process of production, also a set of mandatory standards suitable for trades such as pharmacy, food,etc..
As the intersection of medicines and for producing and quality control basic criterion, GMP suitable for the intersection of medicines and the whole course that preparation produce and influence finished key process of quality in the the intersection of raw materials and the intersection of medicine and production. World Health Organization begins to organize making medicines GMP in the sixties of last century, China has pursued since the eighties of last century. In 1988, China issued one's own medicines GMP, and did the first revision in 1992.
After State Pharmaceutical Inspection Administration was established on August 19, 1998, made the form release " standardard management of quality of production of medicines " (revised in 1998) with the chief No. 9 ,It is implemented formally that since August 1, 1999 and in 2004 the first time in national mandatory implementation GMP.
Before this new GMP announces, have already spread many times new GMP will issue the news of falling soon. The national medicines are supervised at the working conference safely in 2011 when hold on January 24 this year, the national food medicines Deputy Bureau Director of supervision bureau Wu Zhen reveals, it is one of the key contents of safe supervision of medicines in 2011 years to do the propaganda, training of new GMP well and work with all strength.
It is reported, new GMP overweights the improvement of the software facilities of manufacturing enterprise, includes a set of improving, ripe administrative systems, regard using for measuring the person appearing in the production procedure as loophole of neglecting etc., including links such as raw materials, technological process, sterilizing, technology, prescription preparation, storehouse and logistics,etc..
"For example on the production environment, the new GMP necessary cleaning of producing medicines is divided into A, B, C, D four ranks, having introduced the trends to monitor continuously, namely the detection in process of production. " Group's production of wide medicine develops the Vice Minister, senior engineer He GuoXi's introduction of giving an example, upgrade the respect in the medicines production management standard, new GMP has consulted the standards of U.S.A. FDA, European Union, and then combine the China's actual conditions to work out, " to a certain extent stricter than U.S.A.'s FDA, European Union's standard. "
One participate in new the intersection of GMP and the intersection of person who survey and study, draft, revise, appear in the newspaper and the intersection of Bureau of Drugs Supervision and the intersection of seminar and expert of work reveal too in the whole journey, new edition and 1998 significant differences of edition GMP are: At hardware, requirement for aseptic preparation enterprise improve a lot, put emphasis on production process aseptic purifying, requiring further. " whether aseptic preparation of our country emphasize static behavior just in the past, now " The static behavior " Sum " The trends " Reach the standard required. "

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