The first round of new GMP will be extended to some pharmaceutical companies or transferred to other banks

With less than four months to go before the first round of GMP certification, the situation of domestic pharmaceutical enterprises is "double ice and fire" As the new version of GMP refers to the US FDA (food and Drug Administration) and EU standards, the threshold is much higher than the previous round of standards The last round of GMP has a great impact on the industry Now the new version of the standard is higher, which is a challenge for the industry Some enterprises are difficult to meet the standard, and some small enterprises may be out of the game The so-called new GMP refers to the revised GMP for drug production quality management in 2010, which was issued by Chen Zhu, then Minister of health The new GMP puts forward higher requirements for the production of sterile preparations and APIs According to the regulations, pharmaceutical enterprises engaged in the production of sterile drugs such as blood products, vaccines and injections must meet the requirements of the new GMP before December 31 of this year, while the time for other pharmaceutical enterprises to meet the requirements will be extended to the end of 2015, and pharmaceutical enterprises that fail to meet the requirements within the time limit will lose their pharmaceutical production qualification "The new version of the standard is much stricter than before, some of which are even more stringent than international standards This is a huge challenge for many enterprises At that time, the pharmaceutical industry will face a reshuffle That's what this industry is all about The better the survival of the fittest, the higher the R & D technology and safety factor of drugs " A technician from a large pharmaceutical enterprise in Jiangsu told reporters that it is not so much a transformation, but rather a supplementary course Some of the original production line when the new version of the GMP certification as a reference for enterprises now do not have to worry "Some enterprises just don't pay attention to it They think that the country has issued many versions of GMP certification before, which is not a big deal Now many enterprises are betting to see if the country will strictly follow this deadline " The aforementioned person explained that the State Drug Administration had stressed on several occasions that it would neither reduce the standards nor relax the time limit The reporter learned that it usually takes at least 3 to 5 months for the new GMP transformation of aseptic preparations, and it is better for manufacturers to have more than half a year's inventory, which is a challenge for those enterprises that only have one workshop for one dosage form In addition, some small and medium-sized enterprises are hesitant because of the direct costs of transforming the production line and standardizing the production process, as well as the indirect costs of manpower and time spent in the process of submitting materials and certification "I don't rule out that some small enterprises will simply switch to the leading enterprises, no longer do production business independently, or directly accept other orders to do it." Said the person.