According to the deployment of the State Administration of Pharmaceutical Products, Chinese pharmaceutical enterprises must complete GSP certification before the end of 2004, otherwise their pharmaceutical business qualification will be cancelled according to the relevant provisions of the Drug Administration Law. GSP certification is related to the survival and development of enterprises, and the certification period is imminent. But so far, only a few enterprises have been certified. According to the statistics of the State Administration of Pharmaceutical Products, by the end of 2002, * * a total of 13 1 pharmaceutical trading enterprises had obtained GSP certificates, which was less than 1% on the basis of the existing 1250 pharmaceutical wholesale enterprises and 1600 pharmaceutical retail enterprises in China. These conditions not only show that the progress of GSP certification is far behind the certification plan formulated by the national drug supervision and administration department, but also there is a big gap between the current situation of drug trading enterprises and the requirements of GSP. Based on the information obtained by the author through interviews and surveys, the following paper summarizes the problems existing in the implementation of GSP in enterprises, and puts forward corresponding suggestions to solve the problems, with a view to helping enterprises that are carrying out GSP certification. 1. Problems in the implementation of GSP in enterprises 1. 1 ideological understanding (1) On the ideological understanding of the person in charge of enterprises, many enterprises implement GSP irregularly and incompletely, just to cope with inspections, and their main responsibility lies with the person in charge of enterprises. In reality, some business leaders have the following two wrong tendencies: First, they lack strategic vision. The person in charge of this kind of enterprise only pays attention to the operation of the enterprise and ignores the quality of operation. They think that the implementation of GSP will bring extra burden to enterprises, such as the purchase of equipment, the deployment of personnel, the establishment of management system, etc., and it needs to increase certain manpower, material resources and financial resources. They also think that it interferes with the normal operation of the enterprise, feels that the loss outweighs the gain, and produces contradictory ideas. They implement GSP's short-term behavior of "cutting corners", perfunctory things, and muddling through by improper means, lacking strategic thinking of enterprise management. Second, there is luck. Some business leaders believe that "there are very few companies that have passed the certification at present, and I am not the only one who cannot meet the standards. At that time, the State Administration of Pharmaceutical Products will have to lower the standards, and there will be a road ahead. " They are procrastinating, not actively reporting, but waiting for luck. Some people think they have a good relationship with relevant parties, or state-owned enterprises. At that time, the Food and Drug Administration will always have to pass, so they will muddle along without a sense of urgency. Others subjectively think that the decentralization of GSP certification authority from the State Pharmaceutical Products Administration to the provincial US Food and Drug Administration is equivalent to lowering the standards and relaxing the conditions, so they feel that the pressure is not great and they can't make serious preparations as required. (2) With regard to the employees' ideological understanding during the implementation of GSP, many employees in enterprises expressed indifference and thought it was irrelevant; Even some employees think that after the implementation of GSP, the requirements in many specific jobs are much stricter than in the past, which is a constraint on their own behavior. The existing knowledge and skills can't meet the new job requirements, and even there are some conflicting and uncoordinated emotions. 1.2 didn't understand GSP thoroughly, didn't know how to implement GSPGSP and its implementation rules, and put forward specific specifications for enterprises. However, because GSP only requires enterprise behavior in principle, some enterprise leaders and their employees generally have the phenomena of insufficient basic knowledge of pharmacy, low professional quality and deviation of management level, and enterprises often feel helpless and powerless in the specific operation process. For example, I don't know how to connect work links according to GSP requirements, how to deal with field work specifications according to GSP requirements, etc., and I lack understanding and understanding of GSP. 1.3 There is a deviation in the understanding of GSP terms. In the specific implementation process, there are some unclear terms. In the process of implementation, these enterprises either blindly adhere to the terms and form a one-sided understanding, which makes it impossible for their GSP implementation to form a complete system; Or "thinking", mechanically copying the practices of other enterprises, divorced from the actual management of this enterprise, is not helpful for this enterprise to really improve the quality of drug management. 1.4 does not pay attention to the construction of "software". Many enterprises think that hardware facilities are the key to ensure the quality of drugs and the implementation of GSP, but they don't pay enough attention to the implementation of "software" such as systems, documents and personnel required by GSP, and their understanding of "software" is biased. 1.5 part-time job is serious. At present, there is a serious shortage of senior pharmaceutical talents, especially licensed pharmacists in China. For various reasons, many pharmaceutical enterprises cannot retain or absorb senior talents. Therefore, GSP requires full-time quality management personnel to hold some positions, which are often held by a business manager in an enterprise, and even some enterprises employ outsiders as the person in charge of enterprise quality management in name. The implementation of 1.6 GSP is only a case, and the quality of drugs cannot be guaranteed. Although some enterprises carry out GSP in full swing, they only pay attention to the form, and their awareness of quality management is still weak, so the quality of drugs can not be guaranteed. The reasons are as follows: (1) The quality management organization is not perfect and the personnel are not in place. (2) The quality consciousness of the person in charge of the enterprise is still weak. On the one hand, quality management and economic benefits are unilaterally opposed, and it is wrongly believed that strengthening quality management will hinder the operation of enterprises and affect their economic benefits; On the other hand, it is unilaterally believed that the quality of drugs is controlled by production enterprises, and the quality management of drug trading enterprises has no substantive role. (3) Employees' quality awareness is not strong. Some employees think that quality is the business of the quality management department, especially those in the purchasing department and the sales department, and think that quality has nothing to do with themselves. In fact, procurement and sales occupy a very important position in quality management and are the most important links to ensure good quality. In addition, drug acceptance, in-store maintenance, out-of-store inspection and out-of-store transportation all directly affect the quality of drugs. Moreover, the quality consciousness of all employees of the enterprise directly affects the quality of drugs and the reputation of the enterprise. 1.7 only wants to pass the certification, but some enterprises that lack long-term persistence understand GSP as a line of life and death, and those who surpass it can continue to live, or even better, and think that they can rest easy from now on. These enterprises only seek certification and lack long-term work arrangements. Therefore, this phenomenon appears in some enterprises; The preparation for certification is very active. Once the on-site certification is over, management will be relaxed intentionally or unintentionally, and the management level will decline. 2. Suggestions on solving the problems existing in the implementation of GSP 2. 1 Change old ideas and establish a sense of competition. After China's entry into WTO, foreign pharmaceutical enterprises will quickly enter the China market, and their abundant capital, advanced operation mode and technology will have a great impact on the pharmaceutical industry in China. To participate in the competition, we must abandon the traditional mindset, management concept and operation mechanism, and meet the challenges in accordance with internationally accepted models and rules. The GSP certification system implemented by the state is an important measure to learn from the international advanced quality management system in order to improve the quality and efficiency of enterprises, increase their comprehensive strength and achieve international integration as soon as possible. Therefore, the person in charge of the enterprise should not regard the GSP as a burden, but as a good opportunity for the further development of the enterprise. In the process of implementation, enterprises should not have short-term investment behavior, or have any luck. The establishment and operation of quality system is a systematic project, which is linked by one link. If any link goes wrong, it will affect the whole system and management quality. Moreover, with the further acceleration of the pace of merger and reorganization of superior enterprises with quality and service as the core, those enterprises with irregular operation are bound to be eliminated by the market. 2.2 Strengthen employee education, and make it clear that the implementation of GSP can not only rely on the actions of a few people, because GSP requires standardized management of the whole enterprise business process, rather than partial and single management. Therefore, enterprises should be people-oriented and pay full attention to the role of employees. They should not only arrange employees to participate in professional skills training and receive continuing education in combination with the reality of enterprise management, but also strengthen publicity and education so that every employee can deeply understand the importance and purpose of implementing GSP in enterprises and improve their enthusiasm. At the same time, according to the specific requirements of operation and management, enterprises must formulate management systems and job responsibilities in line with the actual situation of enterprises, set up posts as needed, equip qualified personnel according to posts, strengthen daily work assessment, and ensure the effective implementation of GSP. 2.3 "carrot and stick", the full implementation of GSP is a management model, and its ultimate goal is to strengthen and improve the management level of pharmaceutical trading enterprises through institutionalized, standardized, effective and sustainable processes. Pharmaceutical trading enterprises should ensure that all activities are managed, all activities are managed, all activities have standard requirements, all activities are carried out according to procedures, and all activities are recorded. Therefore, the implementation of GSP must be "both soft and hard". Operating hardware is an important basis for pharmaceutical enterprises to implement GSP, and "software" requirements also occupy a very important position. If these "software" conditions, such as quality system, management system, post responsibilities and personnel arrangement, are not combined with the hardware conditions of the enterprise, or are not well combined, it will be difficult for the GSP of the enterprise to achieve the required effect, and it will be difficult for the daily management of the enterprise to be standardized and institutionalized, which is harmful to the long-term development of the enterprise. It should be noted that even the best hardware can't work well without real software. 2.4 "Going out" and "Please come in" mean learning from the advanced experience of other enterprises in implementing GSP and learning from the management practices of successful enterprises, so that enterprises can avoid detours in the process of implementing GSP and meet the requirements of standardized operation as soon as possible. However, it should be noted that citation is not the same as the original text, because each enterprise has different habits and solutions when dealing with many work details and on-site operation requirements. If we just imitate blindly without combining with the actual situation of the enterprise, the effect can only be that the appearance is close to the spirit and deviates from the essential requirements of GSP. "Please come in" refers to inviting experts in GSP certification to the enterprise for on-site guidance, teaching methods and experience of GSP transformation, giving guiding opinions on the problems existing in the enterprise and giving "face-to-face" help; In addition, before GSP certification, enterprises can conduct simulated on-site inspection according to the evaluation criteria to find out the problems and gaps existing in enterprises, so as to rectify enterprises. 2.5 Enterprises should continue to act in accordance with GSP requirements. Enterprises should fully realize that standardized operation will be the basis for future survival. After China's entry into WTO, the pharmaceutical market will be a global market. In such an open market, on the one hand, enterprises should "struggle" with many competitors to seek their own living space; On the other hand, we should be responsible for the vast number of consumers and operate our own enterprises in strict accordance with the law. Therefore, enterprises must establish the concept of "sustainable development" and carry out GSP to the end. Drugs have their commodity and particularity, so it is necessary to establish a strict quality assurance system in the field of drug management. Here, we might as well learn from a sentence in Japan's GDP: "Nothing is more important than improving the quality assurance system to impress customers." It is believed that Chinese pharmaceutical enterprises can establish a correct ideological understanding through their own efforts, conscientiously implement GSP, and meet the challenges of the new situation and environment in the pharmaceutical market after China's entry into WTO with greater strength.