Our company successfully passed the on-site inspection of the new version of GMP of the State Bureau.


Time:

2012-01-21

At the beginning of the Spring Festival, good news has been reported frequently. After winning the title of national well-known trademark, our company has recently successfully passed the on-site inspection of the new version of GMP by the GMP inspection team of the State Administration on the lyophilized powder injection workshop of our company. This marks that Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. has become the top ten lyophilized powder injection production enterprises in the country that have passed the on-site inspection of the new version of GMP, it is also the first pharmaceutical manufacturer in Fujian Province to pass the on-site inspection of the "Good Manufacturing Practice for Drugs (Revised in 2010)" (referred to as the "new version of GMP"). This will accelerate the transformation and upgrading of pharmaceutical manufacturers in our province, conform to international standards, and fully implement The new version of GMP has played a good demonstration and leading role.


At present, there are 4682 drug manufacturing enterprises in China, including 1988 injection enterprises (375 large-capacity injections, 385 powder injections, 491 freeze-dried powder injections and 737 small water injections). Since the new version of "Good Manufacturing Practice for Drugs" was formally implemented on March 1 this year, the State Administration has inspected 158 injection manufacturing enterprises according to the new version of GMP, less than 10% of the total number of injection enterprises; Through 67, the inspection pass rate was 42%, of which 10 were freeze-dried powder injection production enterprises, accounting for 2% of the total number of freeze-dried powder injection production enterprises.

The executive meeting of the State Council held on December 7, 2011 put forward the overall goal of drug safety work during the "Twelfth Five-Year Plan" period, requiring that by 2015, 100 percent of drug production will meet the requirements of the newly revised "Drug Production Quality Management Standards", the level of drug safety will be greatly improved, and the people's satisfaction with drug safety will be significantly improved. The newly revised drug GMP is fully connected with the GMP of Europe, the United States, and Australia. It is a major measure to protect advanced productivity, eliminate backward productivity, promote industrial structure adjustment, and enhance the international competitiveness of my country's pharmaceutical industry. At present, some enterprises hope that the certification process will be tight and loose, and they can get away with it. The State Administration has made it clear that the revised drug production quality management standard in 2010 will be fully implemented with a "zero tolerance" attitude, allowing it to pass, allowing it not to pass, and not helping it to pass.

Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. was established in October 1997, started the first phase of technological transformation in March 2000, and passed the national GMP certification on April 21 of the following year. It took only 400 days to build a production base for freeze-dried powder injection and powder injection, and then successively completed the construction of tablet, capsule, bulk drug production workshop and related supporting facilities. After several years of construction, the enterprise has achieved rapid development and has successively passed GMP, ISO9001:2000, GAP, experimental animal room certification and other four certifications. In order to make the enterprise bigger and stronger rapidly, in 2007, when the country has not yet issued a new GMP and there is no standard to follow, in line with the principle of pursuing advanced, standardized and standard, the company designed and built the second workshop of freeze-dried powder injection and related supporting facilities in accordance with international advanced standards such as EU GMP and US cGMP, with a total investment of nearly 80 million yuan. Since the promulgation and implementation of the new version of GMP, the provincial and municipal food and drug administrations, in line with the concept of scientific development and service development, have given key support to Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. as a pilot enterprise for the implementation of the new version of GMP. It has conducted on-site investigations on the construction situation and the implementation of the new version of GMP, held discussions with enterprises, and combined with license acceptance, daily supervision and factory supervision, organize GMP inspectors to provide on-site guidance to enterprises, help enterprises to build a sound quality management system, scientifically and normatively carry out the construction and installation of plant facilities and equipment, revise and improve the document system, and introduce advanced concepts such as quality risk management, OOS, change control, corrective and preventive measures into production quality management activities to ensure that enterprises successfully pass the certification on-site inspection.