How to collect and analyze drug quality information

One is to find out the content of drug quality information, that is, to find out what to collect. Drug quality information is divided into external information and internal information. The external information of the enterprise includes: 1, national laws and administrative regulations on drug quality management, etc. 2, food and drug supervision and management departments at all levels issued a drug quality announcement; 3. Relevant trends and development directions of market conditions; 4. Relevant quality information of suppliers, customers and competitors. 5, the legitimacy and quality assurance ability of drug supply unit business behavior. Enterprise internal information refers to data, records, reports, documents, etc. , formed around the aspects of drug quality, environmental quality, service quality and work quality. The second is to master the methods and channels of collecting quality information, that is, to find out the collection methods. First, the external information of the enterprise, mainly through the websites of food and drug supervision departments at all levels, China Food and Drug Network, China Medical News, TV, newspapers and other publicity media, as well as our customer suggestion book, collects information related to the pharmaceutical business of the enterprise that has an impact on product quality management or enterprise quality management system. Especially in the collection of supplier qualifications, the audit of the first enterprise and the first variety, it should be carefully collected according to the actual situation of the enterprise and the contents to be audited; Second, the internal information of the enterprise shall be collected from the data, records and statements formed during the implementation of the management system such as drug quality acceptance, maintenance, display, sales, prescription deployment, drug disassembly, special drug management, and adverse drug reactions (reports). The third is to carefully sort out and analyze the collected drug quality information to guide the drug quality management of this enterprise, that is, how to use these drug quality information. The purpose of collecting quality information is not to preserve, but to make full use of it. For example, after collecting drug quality announcements and inspection reports, conduct quality internal audit, check whether the enterprise handles drugs with quality problems, put forward handling opinions, and remind the procurement operation risks as a reference for procurement review, so as to make further adjustments. Fourthly, the management data of drug quality information are sorted and catalogued according to time and category, and then filed for future reference. In short, in order to do a good job in drug quality information management, we must conscientiously implement the four links of extensive collection, careful analysis, application guidance and filing of drug quality information on the basis of establishing and improving the drug quality management system.