"The quality is designed" The relevant regulation of the pharmaceutical industry is tightened

Although everyone knows the importance of quality for business development, almost all pharmaceutical companies have the word “quality” in their external propaganda. However, the key to the problem is how to translate the willingness to pursue quality into consistent corporate behavior. How to truly integrate quality into the blood of a company and transform it into a corporate competitiveness?

Under the background of the frequent occurrence of adverse drug events and drug safety as a social concern, the “2008 China Pharmaceutical Quality Annual Meeting” held in Chengdu on November 15 is even more unusual. More than 100 representatives from the drug administration department, the China Pharmaceutical Quality Association and the pharmaceutical enterprises launched a lively exchange and discussion on “how to improve the quality of medicines and promote the healthy development of the pharmaceutical economy”.

Relevant regulations are tightening

At the annual meeting sponsored by the China Pharmaceutical Quality Association, Bi Zhenjia, Director of the Department of Drug Safety Supervision of the State Food and Drug Administration pointed out that some pharmaceutical companies still have some problems in quality management, including evasive supervision over production processes. Replace industrial raw materials with pharmaceutical raw materials for production, in the non-GMP workshop or plant production, cutting corners shoddy, the product is listed on the market without passing inspection, after GMP certification to relax management.

Analysis of the reasons for the above problems is related to the blind pursuit of economic benefits by some companies, weak awareness of responsible quality management, poor understanding of GMP requirements by technical and management personnel, and lack of expertise. In this regard, Bian Jia said, the next step SFDA will continue to revise the relevant laws and regulations, improve the system, continue to increase daily supervision, establish a sound long-term mechanism, the goal is to enable drug companies to consciously implement GMP, eliminate all security risks.

In fact, the quality of medicines is not only produced, but also designed. 70% of quality problems are hidden in the R&D stage. This requires that pharmaceutical companies must pay attention to quality design during product development and development. The SFDA also reflected this change in drug registration management. Yang Wei, deputy director of the SFDA Registration Department, told the participants that since the implementation of the new "Drug Registration Regulations" in October last year, the verification of the authenticity of new drug and generic drug registration applications has been further strengthened through on-site inspections and on-site inspections. And dynamic extraction of test samples, etc., to ensure the authenticity, accuracy and completeness of the application data. "The clinical trial on-site verification is the next step we focus on. This is also the most frequent problem and the biggest deviation." Yang Wei revealed.

Zhang Aiping, director of the SFDA Certification Management Center, pointed out that the revised "Drug GMP Certification Inspection and Evaluation Standard" began to be implemented on January 1 this year. From the actual point of view of the implementation for the past year, in order to ensure the quality of drugs in the production process, SFDA is GMP inspection has gradually been changed to the "species + process" key inspection, inspection procedures, time, personnel, results, etc. to achieve publicity, publicity, and gradually transition to a technology-based technical support model, to achieve the process of pharmaceutical companies monitor.

For this change of GMP inspection mode, most companies expressed that their understanding was not thorough enough. In the past two years, about 2,000 companies have expired GMP certificates and need to undergo renewal inspections. In response, Liu Xinxin, chairman of Sichuan Kelun Industrial Co., Ltd., proposed that the regulatory authorities issue relevant “Guidelines for GMP certification inspections” and establish a communication mechanism between certification experts and companies.

It is worth noting that the pharmacovigilance is also initiated in China when the relevant policies are tightened. Jin Shaohong, executive deputy director of the China National Institute for the Control of Pharmaceutical and Biological Products and director of the SFDA Center for Drug Evaluation, pointed out that pharmacovigilance is a new idea for drug supervision in the international market before and after the listing of drugs. The purpose of pharmacovigilance in China is to improve the quality of medicines and participate in international competition.

Strengthening enterprise quality control is more important

To ensure the quality of medicines, the key to implementation still lies in the implementation of the company. In other words, the quality management of the company is crucial. "Quality should be the ultimate goal of corporate competition," stressed Zhang Hexuan, president of the Chinese Pharmaceutical Association.

Xu Jingren, chairman of Yangzijiang Pharmaceutical Group, believes that product quality and inspection quality are the key to future enterprise competition. It is necessary to strengthen the awareness of quality management and establish a scientific quality management system.

Zhang Aiping pointed out that drug GMP is the process of monitoring the production enterprises, and the key lies in the process transformation and process output of the enterprise. But in this process, as many experts have said, there is a great lack of awareness and behavior in the process monitoring of enterprises. "For example, in some companies' drug quality control systems, self-inspection has not yet formed a system and cannot achieve the purpose or requirement of continuous improvement and constant innovation."

Dr. Sun Xinsheng, vice president of the China Pharmaceutical Quality Association, concluded in recent years that a number of foreign pharmaceutical companies have conducted research and concluded: In terms of philosophy, foreign pharmaceutical companies believe that drug quality is the core of value creation, and the quality control and quality assurance departments are authorized to operate independently. In the quality system, we attach importance to the risk factors of personnel, and scientific management methods are implemented in every aspect of drug production.

“Multinational drug companies have a strict quality management system, and quality management departments have sufficient personnel to perform quality audits, which account for about 20% of production employees. However, the majority of domestic enterprises account for only about 4% of this total; moreover, multinational pharmaceutical companies are Quality management adopts a full participation model, rewards and penalties, and systematic quality management training.” Sun Xinsheng told reporters that multinational pharmaceutical companies will implement scientific management methods in every link of production: there is a strict document management system, Strict inventory management system and GMP-related verification of complete data, in the production process to implement strict quality control, and built a complaint feedback system.