Standardized management of Anhui Huayuan medicine

Since its establishment, the company has carried out its work in full accordance with the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law and the Quality Management Standards for Drug Trading, standardized its operation and achieved remarkable results. All functional departments and employees of the company are required to further standardize the business order, improve the quality assurance system, ensure the quality of drugs and abide by the concept of "Huayuan caring for life" on the basis of the original GSP certification.

1, establish and improve the quality management organization and improve the quality management system of pharmaceutical business.

According to the requirements of GSP, the company has set up six functional departments, including purchasing, quality control, warehousing, sales, finance and computer room, and implemented computer operation and network management. According to GSP requirements, the company set up a quality management leading group headed by Kang Zhongyuan, general manager and quality director. The quality management department of heavy chemical industry has a quality management group and an acceptance group, and the storage department of heavy chemical industry has a maintenance group. In recent years, according to the new laws and regulations promulgated by the state, the quality management department revised and supplemented the original quality management system of drug trading in time, from 26 systems in 2003 to 365,438+0 systems now, so that it can meet the requirements of drug trading. According to the requirements of the Drug Administration Law and GSP, the members of the quality leading group further upgraded and improved the company's hardware and software around ensuring drug quality, standardizing business practices, improving service efficiency and adapting to market demand.

2. Strengthen employee education and training to improve the overall quality management quality of the enterprise.

The company attaches great importance to strengthening staff training and improving the quality of cadres and workers. Personnel with professional titles account for 1 1.4% of the company's total employees. The company can organize training according to the established training plan every year, and the quality management personnel participated in the quality management personnel training course organized by the US Food and Drug Administration as required. In order to further improve the professional quality of employees, the company also reported to the experts of Fuyang US Food and Drug Administration and Taihe County Institute for Drug Control, and organized training for inspection and maintenance personnel, lobby sales staff and other related personnel. In addition, the company also stopped orientation training in time according to the new laws, documents and notices of the National Bureau and local food and drug supervision departments every year, combined with the needs of the post. The company also designated 2007 as "Employee Training Year", invested more than RMB10.7 million, and organized10.5 million employees to go to Beijing for training, so as to strengthen the knowledge of medical laws and regulations and business knowledge and further improve the quality of employees.

At the same time, according to the established physical examination plan, the company organizes people who come into contact with drugs to the health department for health examination every year, and establishes employee health records.

3. Increase investment in equipment and facilities, and optimize operation and storage conditions.

In order to further optimize the company's business environment, better adapt to the business scale of the enterprise and effectively ensure the quality of all drugs, the company invested a lot of money to transform the business hall and office space and purchased equipment. The transformed business hall was spacious, bright and clean. Check the ventilation, drainage, temperature regulation, rat prevention, insect prevention, bird prevention and other facilities in the warehouse frequently, and repair and replace them in time when problems are found. The measuring instruments in the warehouse have been professionally tested by Fuyang Metrology and Testing Institute as required. From the perspective of safety, the company's market investigates fire-fighting equipment and anti-theft facilities, cleans up the environment outside the warehouse, eliminates fire hazards, optimizes drug storage conditions from different angles and levels, and ensures drug quality. The company has invested a lot of money to equip various functional departments with computers, and the number of networked computers has increased from 324 in 2003 to more than 700 now, realizing the whole process microcomputer management of drug procurement, warehousing, sales, quality management and finance, avoiding the loopholes and mistakes of the original manual operation, and upgrading the internal processes of quality management, warehousing and finance several times according to the actual situation, realizing the comprehensive computerized operation of three-in-one accounts in the warehouse and improving the work efficiency.

4, seriously implement the system, strictly control the quality of drugs.

1) drug procurement management: the company implements strict unified procurement, and the procurement department is responsible for obtaining legal procedures for preliminary examination. Procedures include: license, GMP or GSP certificate, drug quality assurance agreement, legal person power of attorney, salesman ID card, qualified supplier quality credit questionnaire, drug approval quality document, quality standard, trademark registration certificate, quality inspection report, purchase contract, value-added tax invoice and other related materials, which must be stamped with the original seal of the supplier. The management of the first camp enterprises and the first camp varieties can be examined and approved in strict accordance with the "Management System for Examination and Approval of the First Camp Enterprises and the First Camp Varieties". First, the purchasing department will ask for information, and then fill in the Approval Form for the First Camp Enterprise or the Approval Form for the First Camp Drug after the preliminary examination. The quality control department will strictly review the legality and validity of the materials, and submit them to the quality director for final approval after passing the review. The quality control department is responsible for establishing the database of the first camp enterprises and the first camp varieties. The purchasing department has a purchasing plan according to the market demand and inventory structure, and can purchase according to the plan. Every drug purchased has a purchase and sale contract with the supplier.

2) Acceptance management of drugs in storage: Before drugs are put into storage, the inspectors can conduct batch acceptance of drugs returned after purchase and sale in strict accordance with the procedures and requirements stipulated in the Drug Quality Acceptance System, and the conclusion is clear. Psychotropic drugs of category II are subject to double acceptance. The inspector found that the bill of lading was inconsistent, the quality was abnormal, the packaging was deformed, damaged and polluted, and the marking was vague. If the label instructions do not conform to the relevant provisions of the state, they should be resolutely rejected, and the Drug Rejection Report should be filled in and submitted to the quality control department for processing.

3) Storage maintenance management: After receiving the drug acceptance form signed by the inspector, the storekeeper agrees to put the drugs into storage, and carries out warehouse, partition and classified storage in strict accordance with the storage requirements and dosage forms of the drugs, and implements color-coded management. Drugs are divided into non-drugs, drugs for oral use and drugs for external use, and drugs that are easy to smell are stored separately. Special management of drug special library, and the implementation of double lock management.

Under the professional guidance of the quality control department, the maintainer should do a good job in the daily maintenance of drugs, record the temperature and humidity in the warehouse every morning and afternoon, take effective control measures in time when it is found that the temperature and humidity exceed the standard, and increase the detection frequency of temperature and humidity in bad weather. Inventory of drugs can be maintained according to the principle of "three three four", and the quality of drugs should be checked regularly. If problems are found, they should be reported to the quality control department in time to avoid drugs with suspicious quality flowing into the society.

4) Outgoing management: The warehouse keeper can produce first, deliver first in the near future, and deliver according to the batch number. The reviewer can check the name, specification, batch number, manufacturer, quantity, quality and other items of the outbound drugs one by one according to the sales bill, and agree to the outbound drugs after confirmation, and make records. When delivering goods to customers, the deliveryman should handle them carefully and stack them according to the requirements of graphic signs on the outer packaging to ensure the quality of drugs.

5) Sales and service management: The company adopts the "unified purchase and distribution" mechanism, and all drugs in the company can be prescribed through networked computers in all branches. But only the sales department is responsible for the audit of customer qualifications and the establishment and maintenance of files. When a customer comes to our company to purchase goods for the first time, he must first submit the company license and relevant qualification certification materials to the sales department for legality and effectiveness audit, register and put on record after the audit, and enter them into the computer to establish the customer's electronic file. Sales staff can only sell drugs to customers who have established files, and the validity period of customer qualification is entered into electronic files. The company implements qualification magnetic card management for the sales of general taxpayer procurement enterprises. When purchasing, they must carry a magnetic card with qualification marks and read the information of the billing unit before invoicing, otherwise they cannot invoice. If the qualification expires, the microcomputer will call the police, and the salesperson can't sell the medicine to the customer, so as to avoid the medicine from flowing to the unqualified or expired unit. Customers' drug quality inquiries, complaints and reports of adverse reactions are collected, recorded and sorted by the sales service personnel of each branch, and reported to the quality control department in time to put forward handling opinions, so as to ensure that each piece has an explanation and each piece has an echo.

6) Management of special drugs: The company has stricter management of special drugs. The supplier is a designated production or business unit approved by the provincial food and drug administration, and the purchased drugs are stored in a special warehouse, which is managed by two people and two locks. Sales customers are also registered in the sales department of our company. All aspects of purchase, sale and storage are closely supervised, which can be operated according to the system, the accounts and goods are consistent, and the records are complete and clear, thus preventing the special management drugs from flowing into illegal channels.

5. Strengthen inspection and pay attention to assessment.

The company's quality management organization is set up reasonably, with clear responsibilities and meticulous division of labor, which can ensure strict control and seamless connection of all links in the whole process of drug management. Purchasing, warehousing and sales facilities and equipment are fully functional, which is suitable for the scale of operation and can ensure the company's rapid and good operation. The company has set up a quality management system implementation inspection team headed by the general manager and quality director, which conducts strict inspection and assessment on the implementation of the quality management system of various functional departments and posts every six months, analyzes the reasons for the problems found in the inspection, and puts forward effective rectification measures within a time limit. After the rectification, the inspection team will review it again until it meets the requirements.