What is the gsp authentication software used in retail pharmacies? The requirements of health bureaus vary from place to place. If there is no unified software, you can use all certified software that meets GSP requirements.
What does GSP require for the location of pharmacies? GSP requires *** 109, in which 6702 stipulates that the business premises and drug warehouses of enterprises should be clean and pollution-free. The remaining clauses have no requirements for site selection.
Gsp certification hardware for pharmacies: store area, business area and warehouse area should be sufficient. There are shelves and warehouses: drug waiting area, qualified area, unqualified area and return area. Air conditioner, refrigerator, fire extinguisher, mousetrap, mosquito killer, mosquito killer, damp-proof board of buffer warehouse, service convention, clothing, famous brand, etc.
Personnel: number of people, skill certificate, education certificate.
Software: various systems, procurement, sales and inventory records. Publicity and publicity of various management systems. Invoice, business license, etc.
If you can't understand what I'm saying, it means you're not ready at all.
Either invite experienced people, or ask the drug supervision department for guidance, otherwise it is a wooden stick.
GSP self-inspection report
* * Drugstore was established on September 27th, 2007, with the business address of * * *, and currently operates about * varieties and specifications. With the strong support of the headquarters, since its opening. No matter from the hardware facilities, personnel institutions, or software systems and management, they are all operated in strict accordance with the "Quality Management Standards for Pharmaceutical Trading" and have undergone self-examination and rectification for * months. The contents and results of the certification self-examination are reported as follows:
I. Management responsibilities
(1) Business scope: prescription drugs, over-the-counter drugs, Chinese patent medicines, chemical preparations, biochemical drugs, biological products and antibiotic preparations. The mode of operation is retail chain. Stores strictly implement eight unified management, including unified purchase, unified distribution, unified quality, unified service standard, unified trade name and logo, and engage in pharmaceutical business activities in strict accordance with the approved mode of operation and scope of business.
(2) Our store has a store manager and a quality manager, who are responsible for collecting, conveying and implementing the policies and information of the headquarters on drug quality management, and guiding and supervising the implementation. The person in charge of store quality is responsible for the management of drug quality inquiry, quality complaint, drug acceptance and unqualified drug treatment.
(3) Establish and improve a set of "quality management system", including 365,438+0 system and 65,438+09 post quality responsibility system, such as audit management of quality policy, objectives and quality system.
Second, personnel and training.
(1) There are 4 employees in our store, all of whom are professional technicians, including 3 pharmacists and others 1 person. Pharmacy professionals account for 100% of the total employees. The person in charge of the store is a pharmacist with a college degree in pharmacy, and the prescription reviewers are all licensed pharmacists;
(2) All employees of our store have participated in the training and assessment organized by the Municipal Food and Drug Administration, and can only work with certificates after obtaining the certificate of approval.
(3) All the new employees in our store have passed the training and assessment of new employees in the headquarters.
(4) A special training center has been set up, and employees regularly receive education and training organized by the headquarters, and education and training files have been established.
(5) The headquarters regularly organizes employees' health checkups every year and establishes complete health records.
Three. Facilities and equipment
(1) All drugs in our store are distributed by the headquarters, and there is no warehouse in the store;
(2) In order to implement GSP standardized management, our store put in/kloc-0 freezer and temperature and humidity detector according to the requirements of drug storage, so that drugs can be stored in cold storage and normal temperature and humidity environment as required. The existing business area of pharmacy is * square meters. The ground of the business premises is smooth and bright, equipped with fire control and safety facilities and equipment.
(3) Our store has a computer and a complete computer software management system for drug retail.
IV. Purchase and Acceptance
(1) All medicines in our store are distributed by the head office. The headquarters of the company has obtained GSP certification in * *, and has conducted the first camp audit on the purchased drugs, and strictly put the drug procurement into the warehouse for acceptance.
(2) Since the opening of our store, the person in charge of quality in the store has inspected the relevant items in strict accordance with the original documents. At the same time, check the appearance of drugs again to ensure that the quality and quantity of drugs sold in stores are qualified.
Verbs (short for verb) are displayed and stored.
(1) The drugs displayed on the counter in our store are classified according to their functions, indications and storage requirements. Prescription drugs and over-the-counter drugs are displayed in separate cabinets, internal drugs and external drugs, and drugs and non-drugs are displayed separately. Prescription drugs are divided into anti-infection system, digestive system, respiratory system, endocrine system, antibiotics, topical drugs and so on. According to the system, OTC OTC drugs are open-shelf. There is also a drug-sniffing counter. The odorous drugs are stored in the odorous medicine cabinet. All the drugs displayed in the store are distributed according to the staff of the whole store, and they are inspected periodically every month and recorded. For drugs with a near-term effect of six months, fill in the early warning form of drugs with near-term effect according to regulations, and urge sales.
(2) The containers and windows for displaying medicines are neat and bright, and there are no personal articles for daily use and other articles unrelated to medicines in the business premises. There is a temperature and humidity detector in the store, which is checked and recorded twice a day as required. The specific time will be arranged at 9: 00- 10: 00 in the morning and 15: 00- 16: 00 in the afternoon.
(3) The medicines needed in our store are uniformly distributed by the company, and the sales are fast and fixed, which ensures that the processed medicines can be replenished in time, and the medicines with refrigeration requirements are put into the refrigerator in time. Drugs are stored on the counter in principle, and a few are stored in counter lockers.
Six, sales and service:
(1) We have established a customer suggestion book, a quality inquiry book and a customer record book. And handle the collected opinions, quality inquiries and complaints in a timely manner. Medication consultation 1 1, guiding medication implementation 1 1, all employees can strictly abide by relevant laws, regulations and rules when selling drugs, and can correctly grasp and introduce the performance, use, contraindications and precautions of drugs, without making false propaganda.
(2) Strictly manage the sales of prescription drugs. When selling prescription drugs, the prescription must be examined and signed by a licensed pharmacist or pharmacist or above before it can be deployed for sale. Both the deployment personnel and the auditor should sign the prescription.
(3) For prescriptions whose compatibility is contraindicated or overdose, the allocator has the right to refuse to allocate or to allocate and sell them after being corrected and re-signed by the original prescriber.
(4) Arrange pharmacists on the job reasonably, ensure that pharmacists are on the job during business hours, and sell medicines when pharmacists are not on the job at night.
(5) The service convention has been formulated, and the supervision telephone number has been published. There are no behaviors such as sales with prizes, giving away medicines or gifts in the store. No adverse reactions occurred in the drugs sold.
Self-examination results: According to the GSP inspection and evaluation standards, our store has basically met the GSP certification requirements, and now we apply for the certification of drug quality management standards according to the Administrative Measures for Certification of National Drug Quality Management Standards (Trial).
* * drugstore
date month year
What are the requirements for gsp certified refrigerators used in pharmacies? The national GSP requires a temperature range of 2-8℃ and 8-20℃ and a humidity range of 35%-75%. I hope I can help you, and the snow swimming refrigerator will answer for you. I hope it can be adopted. Thank you.
Medical cold storage is mainly used to store all kinds of medical supplies that cannot be guaranteed at room temperature. Under the condition of low temperature refrigeration, the shelf life of drugs can be prolonged, and the storage temperature is generally -5℃ ~+8℃.
The warehouse of medical cold storage adopts rigid polyurethane heat insulation sandwich board, which is formed by high pressure foaming process at one time. Double-sided color steel plate adopts advanced eccentric hook and groove hook, and the eccentric connection mode of warehouse plates realizes the close connection between warehouse plates, greatly reducing the leakage of cold air and enhancing the heat insulation effect. T-plate, wall plate and corner plate combined cold storage can be assembled in any space. Scientific design, simple and practical, energy saving and environmental protection.
According to the new version of "Quality Management Standard for Pharmaceutical Trading (revised 20 12)", enterprises should allocate warehouses that are suitable for the scale and scope of business and meet the requirements for drug storage:
The drug warehouse should be equipped with equipment for adjusting temperature and humidity and indoor and outdoor air exchange; Equipment for automatically monitoring and recording warehouse temperature and humidity.
1, medical warehouse
2. On-site inspection
3, warehouse temperature and humidity requirements
Brief introduction of refrigeration system in drug warehouse;
The refrigeration system should be equipped with air conditioning equipment according to the warehouse scale, local temperature and heat preservation. If energy-saving air-conditioning equipment is used, the proportion can be slightly lower than that of ordinary air-conditioning equipment. In North China, for the large-scale warehouse whose daily shipment accounts for 5%~ 15% of the total cargo volume, the warehouse height is less than 3 meters and the heat preservation is good. The reference for estimating the low configuration of refrigeration equipment: the room temperature warehouse is not less than 30㎡/ piece; Cold storage should not be less than 20m2/ horse. When the temperature in the south is high or the warehouse is high or there is no heat preservation, the number of refrigeration equipment should be appropriately increased.
It is suggested to use insulation board for thermal insulation in qualified warehouses, which can effectively reduce heat loss and achieve the effect of energy saving and electricity saving under long-term use; The design of refrigeration system is based on the Code for Acceptance of Construction Quality of Ventilation and Air Conditioning Engineering (GB50243) and the characteristics of warehouse, and cabinet air conditioner, central air conditioner or industrial high-efficiency refrigeration unit are selected respectively.
Small cold storage should be combined with multi-cabinet air conditioning;
Medium-sized cold storage should be combined with modular frequency conversion multi-connected central air conditioning unit plus fan or air duct.
Large-scale cold storage should adopt the combination of industrial high-efficiency screw refrigeration unit and remote air cooler. Screw refrigeration unit is more energy-saving and efficient than piston unit. The PLC automatic control system is divided into 0-50-75- 100%(25% for startup) multistage energy conversion control, which can automatically adjust the operating power of the unit according to the refrigeration load and effectively reduce energy consumption. The industrial device has the characteristics of stable and reliable operation. The later maintenance cost is several times lower than that of the air duct central air conditioning chiller, and the effective air supply distance of the cold fan in the warehouse can reach 30 meters at the farthest. Compared with air-conditioning fans with short air supply distance, the number of fan equipment can be greatly reduced, and the investment and construction costs and operation and maintenance costs are lower than those of ordinary air-conditioning units.
refrigeration unit
Brief introduction of warehouse temperature and humidity automatic monitoring system;
The system is designed in strict accordance with the requirements of temperature and humidity monitoring records in Order No.90 (new GSP) and its appendix in the Quality Management Standard for Pharmaceutical Trading (revised 20 12).
The automatic temperature and humidity monitoring system consists of a temperature and humidity recorder, a measuring point terminal, a management host, a data backup memory, an uninterruptible power supply and temperature and humidity monitoring system software that meets the requirements of the new GSP. It has the functions of temperature and humidity automatic monitoring and recording, SMS alarm, power failure alarm, UPS uninterrupted power supply, data backup, data automatic upload and so on, which meets the online supervision requirements of Food and Drug Administration. The temperature and humidity monitoring system and refrigeration system are set separately and run independently, which meets all the acceptance requirements of the new GSP.
Each measuring point terminal of the temperature and humidity monitoring system can collect, transmit and alarm the environmental temperature and humidity in real time. The management host can collect, process and record the data monitored by each measuring point terminal, and store and back it up every day, and has the function of alarm management in abnormal situations. The system automatically generates temperature and humidity monitoring records, including the temperature value, humidity value, date, time, measuring point position, reservoir area or vehicle category of each monitoring channel; The system stores, displays, prints and exports real-time monitoring data and historical data in the form of encrypted file format, Excel tables and graphs. The remote data automatic uploading interface is reserved to meet the online supervision requirements of the Food and Drug Administration.
What are the new requirements for software in the new gsp? The new version of GSP has comprehensively improved the standards and requirements of software and hardware for enterprise management, put forward new requirements for computer systems, real-time monitoring of storage temperature and humidity, cold chain logistics and transportation equipment of pharmaceutical enterprises, raised the market access threshold, helped to curb low-level duplication, promoted industrial restructuring and increased market concentration.
Founded in 1992, Beijing Moke Technology Co., Ltd. is one of the earliest manufacturers providing enterprise information services in China. For a long time, Cohen Technology has been committed to promoting the in-depth application of enterprise informatization, not only providing customers with information solutions, but also providing customers with information services such as enterprise management consulting, implementation and maintenance, and project training. In particular, he has been paying attention to the pharmaceutical industry for a long time and has become a leader among information service providers in the pharmaceutical industry.
What should I do for the new GSP certification of 20 14 pharmacy? Must go to the computer system and freezer that meet the requirements of the new GSP. The rest shall be prepared one by one according to the Guiding Principles for On-site Inspection in good manufacturing practice.
What is the impact of the withdrawal of gsp certification by pharmacies? See the treatment conclusion later.
After the results are processed, re-apply for GSP certification within the time specified by the Food and Drug Administration.