GMP certification canceled the latest news announced

In the future, supervision and inspection records will become proof of compliance with GMP requirements, because the law requires the disclosure of all regulatory results, and each enterprise, the result of each inspection, is proof of GMP compliance.

▍ What is proof of compliance after GMP?

Recently, industry authorities said in an interview with Cyber Blue: The cancellation of GMP/GSP certification is not new, it started a few years ago.

The above-mentioned person gave Cyberland an example: the cancellation is only "certification", not GSP and GMP itself. It is equivalent to the original "carp leaping over the dragon gate"-after this level, you are the "good person"; but now it is a state-the regulatory authorities must maintain "continuous attention", which is simply "continuous compliance". Pharmaceutical manufacturers must always keep the entire production status in compliance. The regulatory authorities do not need to say hello, just push the door to check at any time.

He further said that after the cancellation of certification, pharmaceutical companies do not need to do post-listing certification inspections. The regulatory authorities put all inspections before listing and continue to supervise production compliance with GMP through daily supervision, which is consistent with the common practice in developed countries.

Site change and other management needs on-site inspection, confirm the GMP status of the need to do a good job of convergence, in order to optimize the work process, reduce administrative links.

▍ Without certification, which enterprises will be good?

In 1998, China introduced GMP certification with reference to international standards, which put forward clear requirements for enterprises in various production links from plant to ground, equipment, sanitation, air and water purification, and emphasized that all drugs cannot be produced without certification.

Cui Yan, senior vice president of Hehuang Medicine, said to Cyberlan on the incident that the cancellation of certification this time seemed to be a loose admission, but in fact the supervision department moved the work center to supervision during and after the event. In the future, dynamic flight inspections will increase and the investigation will be intensified. Therefore, pharmaceutical companies should pay more attention to the production quality management, which tests the daily internal skills of pharmaceutical companies.

Another person in charge of quality management of a pharmaceutical company told Cyberland: in the past, when producing new drugs, there must be new drug certificates and GMP certification, but now it has been canceled, so whether this drug is good or bad needs to be judged by the enterprise. In addition, due to the increase in the frequency of flight inspections, the requirements for daily management will be higher to cope with irregular flight inspections.

Cui Yan further said: GMP and GSP management are the foundation of pharmaceutical enterprises, and quality is the lifeline of enterprises. As a pharmaceutical company, establish a sound quality management system, always take GMP standards as the habit of daily work, do self-examination and self-correction from time to time, do a good job in staff training, and root the concept of quality management in the hearts of employees. Then no matter how the national policy changes, enterprises have their own confidence to deal.

It should be noted that, to some extent, the cancellation of GMP/GSP certification is to streamline administration and delegate power, release policy dividends-the reduction of government approval matters has become a requirement of the enterprise itself, which is good for enterprises that originally attached importance to quality management and a threat to enterprises that are accustomed to opportunism.

▍ Cancellation of certification for further MAH

In fact, as mentioned above, the statement of cancellation of certification has been circulating in the pharmaceutical circle for many years, and the new version of the "Drug Administration Law" was voted through, which was a final decision and gave the industry a dose of reassurance.

There are views in the industry that the top priority of the revision of the Drug Administration Law is the drug marketing license holder system. Around the whole life cycle and whole process supervision of the product, the marketing license holder is responsible for the safety, effectiveness and quality controllability of the drug in the process of drug development, production and operation. At this time, if GMP certification is still implemented, the quality management responsibility is still on the manufacturer, This will weaken the relevant responsibilities of the marketing license holder.

Cui Yan also expressed similar views. She believed that the cancellation of certification was a preparation for the subsequent promotion of the listing license holder (MAH). As the first person in charge of drug production, the quality management system of the listing license holder surpassed the traditional system. For the entrusted drug production enterprises and sales enterprises, the whole process management should be carried out, and a more complete cross-regional and cross-enterprise quality management system should be designed, this is also an opportunity for China's pharmaceutical industry to achieve transformation and optimize the integration of industry resources.

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