A new version of GMP extensive solicitation of opinions of particular concern to essential medicines




On August 27 at the "improve the quality of drug production Seminar", the State Food and Drug Administration (SFDA) Drug Safety Supervision Department, said the person in charge, new version of "Good Manufacturing Practice" (GMP) are being actively modified and extensive solicitation of opinions, SFDA are actively promoting the revision of the strive for an early release.

The official also said that in order to ensure the quality and safety of national essential medicines, SFDA requirements, the promulgation of a new version of GMP, the national production of essential medicines should be the first to achieve a new version of GMP requirements.

To move closer to the international advanced level

China's current GMP has been promulgated and implemented since 1999 a full 10 years.
Development has gradually revealed some shortcomings, such as: stress pharmaceutical companies in the hardware construction, software management, especially the staff requirements involved is small; a lesser punishment, it is difficult to play the real role of the normative constraints; In addition, the lack of complete quality management system requirements, quality and risk management, change control, deviation handling, corrective and preventive measures, exceeding the results of the investigation are the lack of clear requirements. To this end, SFDA from September 2006 officially launched the revision of GMP.

State Food and Drug Administration Drug Safety Supervision Department person in charge said that the revision of the guiding principles are: to meet the supervision of the practical needs of pharmaceutical manufacturing companies to upgrade the international competitiveness, and WHO and other international pharmaceutical manufacturing practices align to promote the drug in the future of China's international market.

According to reports, when compared with the current GMP, revised version of the required enterprises to establish a comprehensive quality assurance system and quality risk management system; the production and commissioning of the commission also made clear testing requirements; additional authorized person of quality, quality risk management, product quality retrospective analysis, continued stability of the study scheme, supplier audit and approval of content, require each enterprise has a quality of an authorized person is responsible for enterprise release of the final product. It also increased change control, deviation handling, excessive investigations, corrective and preventive measures and so on.

Previous legislation idea of more regulation in the hypothetical non-relative who developed under the premise of honesty and trustworthiness penalties. The GMP is the introduction of this amendment, some new idea that people who supposedly control the relatively honest and trustworthy, if there is fraud, man-made false records, immediately ruled not pass the inspection. The new law embodies the idea of more user-friendly is the new version of GMP's one major bright spot.

Another major highlight of a new version of GMP is to emphasize the drug production and drug registration and post-marketing regulatory links.

"We can not just stare at the eyes production processes, product listing is not the end of the story, but also close attention to drug safety, and if the standard is not high, there is no guarantee the safety of medicines, to really carry out the phase-out." The charge of the person said. He revealed that, at present, SFDA has been combing over 50 have clinically low standards do not apply, or drug varieties will come out before the end of this year a number of such products.

Emphasized that "the principle of mastery" is a new version of GMP is another bright spot. Real business situations vary widely, the new GMP how to adapt to different business? It is reported that this amendment had increased in most sections of "principles" section, appendix also increased the content of general principles. Clearly the basic principles in order to inspectors in the future rule-based, evidence-based.

In addition, the revision also involved to improve the operability, refine software requirements, to absorb the international advanced integrated pharmaceutical GMP content.

The official pointed out that, GMP is leading the entire drug safety supervision, should proceed from the overall development of the strategic vision to develop a new version of GMP, through this platform to build GMP regulation, promulgated a series of regulatory documents, or approach, form a joint force in the daily supervision .

Special attention to essential medicines

GMP is to improve access to drug production threshold of an important specification document, and its standard was raised, it must have been a number of enterprises have been eliminated for failing to compliance, which involves the entire socio-economic development and stability, and that, GMP revision work is very carefully.

According to the relevant person in charge, the revision to first be several provinces such as Sichuan and Jilin, a number of industry associations and some businesses to assess the new version of GMP and see how many businesses are affected, how many companies can meet this standard. And then submitted to the Ministry of Health and the State Department assessment, followed by public comment and then the Internet, while the convening of a forum for further views.

Taking into account the business in a short time be raised to a new version of the standard is not realistic, therefore, after the promulgation and implementation of new GMP for GMP certification has been made available in the new version of GMP after the release of two to three years, take the initiative against a new version of the standard step by step, phased classification implementation. As for the new release after the new GMP pharmaceutical manufacturing company or build a new workshop, the need to implement a new version of GMP; for essential medicines, in principle, a new version of GMP released after the production enterprises should take the lead to new standards.

For the current industry profile of essential medicines, the new GMP given special attention and demands. Prescription of essential medicines, technology, etc. will be re-verified, and after the enactment of a new version of GMP, pharmaceutical enterprises in the production of essential drugs, must achieve a new version of GMP requirements; for some of the basic drug production than larger enterprises, in new factories, workshops in the process, they should consciously raise against the new standards.

At the seminar, to the meeting of business people expressed strong support for the revision and implementation of a new version of GMP, and some companies are now already in accordance with the new concepts and requirements of GMP controls to improve. At the same time, enterprises also put forward, in accordance with the implementation of the new standards will definitely increase costs, wants the state to put self-supporting measures to encourage enterprises to actively carry out a new version of GMP.

It is understood that implementation of the system around the essential drugs, the state will introduce a series of policies to encourage enterprises to improve their standards of innovation. Industry experts point out that in the future, at least in the drug tender time, whether the new GMP standards, will serve as an objective standard, therefore, take the initiative to actively improve the control according to the new standard will be conducive to the development of enterprises.
2009-09-08