Announcement of the latest news of GMP certification cancellation

In the future, the supervision and inspection records will become the proof of the enterprise's compliance with GMP requirements, because the law requires that all the supervision results be made public The result of each inspection by each enterprise is the GMP compliance certificate ▍ what is the compliance certificate after GMP? Recently, in an interview with cypress blue, industry authorities said: it is not a new thing to cancel GMP / GSP certification, as early as a few years ago In the future, the supervision and inspection records will become the proof of the enterprise's compliance with GMP requirements, because the law requires that all the supervision results be disclosed Every enterprise, the result of each inspection, is the GMP compliance certificate For example, the above-mentioned person told cypress blue that "certification" was cancelled, not GSP and GMP It's the same as "carp leaping into the dragon's gate" in the past After this pass, you are the "good man"; now it's a state that the regulatory authorities should keep "continuous attention", which is simply "continuous compliance" The pharmaceutical manufacturers must keep the whole production state compliant at all times The regulatory authorities need not say hello and push the door at any time for inspection He further said that after the cancellation of the certification, pharmaceutical enterprises do not need to conduct post market certification inspection The regulatory authorities put all the inspections before the listing, and continue to supervise the production in line with GMP through daily supervision, which is consistent with the common practice in developed countries Site change and other management need on-site inspection to confirm GMP status, so as to optimize work procedures and reduce administrative links ▍ no need for certification, which enterprises will benefit? In 1998, China introduced GMP certification in accordance with international standards, which put forward clear requirements for various production links of enterprises from plant to ground, equipment, sanitation, air and water purification, and stressed that all drugs cannot be produced without certification Cui Qimin, senior vice president of Hehuang pharmaceutical, told sapperland about the incident that the cancellation of certification seemed to be a loosening of access, but in fact, the regulatory department moved the work center to the post event supervision, in the future, the dynamic flight inspection will increase, and the investigation and punishment will increase Therefore, more attention should be paid to the production quality management of pharmaceutical enterprises, which tests the daily internal skill of pharmaceutical enterprises Another person in charge of quality management in a pharmaceutical company told saberland: before new drugs were produced, new drug certificates and GMP certificates had to be provided Now they are cancelled, so whether this drug is good or not needs to be judged by the company In addition, due to the increased frequency of flight inspection, the requirements for daily management will be higher to cope with the irregular flight inspection Cui product min further said: GMP, GSP management is the foundation of pharmaceutical enterprises, quality is the lifeline of enterprises As a pharmaceutical enterprise, establish a perfect quality management system, always take GMP standard as the habit of daily work, conduct irregular self inspection and self correction, do a good job in staff training, and root the quality management concept in the hearts of staff No matter how the national policy changes, enterprises have confidence to deal with it It should be noted that, to some extent, to cancel GMP / GSP certification is to streamline administration and delegate power, release policy dividend - the reduction of matters approved by the government becomes the requirements of the enterprise itself, which is good for the enterprises that originally attached great importance to quality management, and the enterprises that are used to opportunism are threats ▍ cancellation of certification, in order to further promote MAH, in fact, as mentioned above, the cancellation of certification has been popular in the pharmaceutical circle for many years, and the new version of the drug administration law was voted through, which is a final decision and a reassuring pill for the industry
There are opinions in the industry that the top priority of the revision of the drug management law is the system of drug listing license holders Focusing on the whole life cycle and process supervision of products, the listing license holders are legally responsible for the safety, effectiveness and quality controllability of drugs in the process of drug development, production, operation and use right At this time, if GMP certification is still implemented, then the responsibility of quality management remains In the case of manufacturers, this will weaken the responsibilities of the holders of listing permits
Cui Qimin also expressed a similar view She believed that the cancellation of certification is the preparation for the promotion of MAH As the first person in charge of drug production, the quality management system of MAH goes beyond the traditional system For the entrusted production and sales enterprises of drugs, they should carry out the whole process management and design a more perfect cross regional and cross regional The quality management system of the enterprise is also an opportunity for the transformation of China's pharmaceutical industry and the optimization and integration of industry resources.