Interpretation of the highlights of the new GMP specification
Interpretation of the highlights of the new GMP specification
REVIEW: 98 version of GMP and GMP WHO compared with other advanced countries, there are gaps in the standard level; the terms of the content is too principles, guidance and operability is not strong; in particular, is not comprehensive and specific software management; Lack of complete quality management system requirements; in actual work, heavy hardware, light software; and drug registration management, adverse drug reaction monitoring, drug inspection and other related supervision work is not enough, it is difficult to form a synergy in daily supervision work.
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State Drug Administration since its inception in 1998 August 19, attaches great importance to the revision of GMP, has held several forums to listen to opinions from all sides, especially the implementation of the main drug GMP - the views of drug manufacturers, Organize relevant experts to carry out revision work. At present, the "Good Manufacturing Practice" (revised 1998) by the State Drug Administration Order No. 9 issued by the Secretary, and took effect on August 1, 1999. After five years of revisions for public comment two of the "Good Manufacturing Practice (revised 2010)" (hereinafter referred to as the new pharmaceutical GMP) became effective on March 1, 2011.
　　
At the 21st National Pharmaceutical Economic Information Conference, the Deputy Director of the National Food and Drug Administration (SFDA) Drug Safety Supervision Department said that SFDA is striving to launch a new version of GMP by the end of the year and plans to officially implement it in 2010 .
　　
The reporter of the "Medical Economics News" learned that, unlike the 98 version of GMP , the emphasis on hardware facilities is that the new version of GMP will greatly increase the requirements for software, and the requirements for aseptic production will be greatly improved. This is tantamount to the difficulty of implementing the manufacturer's quality assurance level.
　　
* According to Xiong, the main amendments to GMP GMP World Health Organization (WHO) is modeled with a focus on software and improve management.
　　
Increased supervision level requires GMP synchronization
　　
*Xiong pointed out that the 98 version of GMP has a gap in the standard level compared with WHO and other advanced countries' GMP ; its terms are too principled, and the guidance and operability are not strong; especially in software management, it is not comprehensive enough. Specific; lack of complete quality management system requirements; in actual work, heavy hardware, light software; and drug registration management, adverse drug reaction monitoring, drug inspection and other related supervision work is not enough, it is difficult to form synergy in daily supervision work.
　　
　　 A senior SFDA person has pointed out that the quality of standards determines the quality of supervision. Without high standards, there will be no high level of supervision. According to relevant sources, the GMP standard was greatly improved because the 98 version of the GMP standard is not high, which is not conducive to the development of supervision and inspection, and has not reached the point where it cannot be changed.
　　
According to the reporter's understanding, due to the deficiencies of the original GMP , many domestic enterprises have the phenomenon of “ re-certification and light management †. In recent years, in some serious phytotoxic events, many injection production companies have changed their production processes. And parameters, the use of industrial raw materials to replace the phenomenon of medicinal raw materials. Therefore, the new version of GMP draws on the regulatory experience of the regulatory authorities of the WHO and the European Union and other countries, and adopts time-to-time and full-time follow-up monitoring to ensure product quality. According to reports, this revision adds quality attorneys, quality risk management, product quality review analysis, continuous stability inspection plan, supplier audit and approval, change control, deviation management, over-standard (OOS) investigation, corrective and preventive measures. (CAPA) and other content.
　　
According to *Xiong, the above new measures have been tried in some enterprises to promote the quality management of enterprises. At present, the Chinese version of 98 GMP certification by the pharmaceutical preparations and chemical raw materials enterprises with a total number of 4700, after the revised standards improve, SME survival difficult part of management weakness may therefore be eliminated.
　　
Regarding the fear that the enterprise is too unbearable for a short period of time, *Xiong pointed out that the new version of GMP will be implemented in phases, among which new drug manufacturers and production workshops should implement new standards in 2010 , and now they have passed the 98 version of GMP. Certified companies can complete hardware retrofits within two or three years, and companies that produce essential drugs should be the first to implement them.
　　
The reporter found that enterprises that produce essential drugs pay special attention to GMP reform. These companies agree that they cannot lose the opportunity to produce essential drugs because of problems with GMP .
　　
Emphasis on aseptic production standards
　　
According to *Xiong, the purpose of this GMP revision is to comprehensively improve the quality assurance of pharmaceutical products, and on this basis, promote the export of Chinese pharmaceutical preparations and APIs. Lu Yiwu, assistant general manager of Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd. believes that the new version of GMP is in line with international standards and can clear the obstacles for China's drug exports.
　　
The GMP revision work refers to the GMP and its appendices of the WHO , the European Union, and the US FDA . It also refers to the requirements of the Q7A of ICH . Of course, it also combines the actual situation of domestic enterprises and retains some of the 98 version of GMP .
　　
In this revision, the production standards for aseptic products have been greatly improved. According to *Xiong, the new version of GMP refines the requirements for simulated filling, sterilization verification and management of the culture medium, increases the specific requirements for aseptic operation, and strengthens the measures for sterility assurance; the purification level adopts the WHO standard and implements A. , B , C , D four standards. The static and dynamic monitoring of suspended particles, the monitoring of planktonic bacteria, sedimentation bacteria and surface microorganisms are all set in detail and the monitoring conditions are clearly stated.
　　
Although the requirements for aseptic production are high, manufacturers generally agree. Ye Hong, a technical expert at Zhengda Youthbao Pharmaceutical Research Institute, believes that compared with developed countries, the gap between China's GMP and developed countries is mainly reflected in aseptic production. This new version of GMP raises relevant standards, which will help China's products to improve competition for export. force.
　　
According to industry insiders, the cleanliness requirements currently implemented in China differ from the WHO standards and EU grading settings. Most large-volume injection companies and some freeze-dried powder companies need to be transformed.
　　
In addition, for the export of raw material drugs, the integration of production with foreign standards is also conducive to the export of raw materials. In order to export to Europe and the United States, many API companies have to build workshops that meet foreign GMP standards. The investment is huge and the utilization rate is very low. According to Yan Longgang, deputy general manager of Oushi Pharmaceuticals of Shijiazhuang Pharmaceutical Group, a part of the oral preparation workshop of the factory has passed the EU certification, which has a large investment and high operating cost. The efficiency of the workshop is reduced by 5 to 10 times compared with other workshops . The cost has increased by 2 to 3 times. And if a new round of GMP transformation can make all the workshops reach the international level, it can also effectively improve the utilization rate of the workshop equipment and reduce the operating cost, which is also recognized by the industry.
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