1. pharmacy self-inspection report
In order to implement the spirit of the document 19971February 1 1/. According to the requirements of the provincial, state and county human resources and social security bureaus, and in combination with the standards of Yunnan Province Basic Medical Insurance Drug List, Yunnan Province Basic Medical Insurance Diagnosis and Treatment Project and Yunnan Province Basic Medical Insurance Service Facilities Standard, Renxin Pharmacy organized all employees to carry out self-inspection of designated medical insurance pharmacies. Now the self-inspection and self-inspection are reported as follows: 1. Our pharmacy hangs the certificate of designated retail pharmacy, announces the service, announces the complaint telephone number, and the business license, drug business license and drug business quality management standard certification certificate are all within the validity period.
Second, this drugstore has strict rules and regulations on the import and sale of drugs. Pharmacy staff conscientiously perform their duties, carefully examine the starting enterprises and varieties, establish files, and ensure that the purchase channels are formal and legal, and the accounts, tickets and goods are consistent.
Three, the pharmacy business hours at least one pharmacist on-the-job, the pharmacy door has obvious signs to buy medicine at night. All business personnel hold employment certificates, health certificates and professional qualification certificates issued by relevant authorities, and all certificates are within the validity period. Pharmacists need to hold relevant certificates.
4. The pharmacy has a business area of 284 square meters. * * * is equipped with four computers, three of which are equipped with drug retail software. 1 is equipped with a medical insurance system, which is connected with the medical insurance system of Nujiang Prefecture through a special line. Equipped with corresponding management personnel and cleaning personnel to ensure the normal operation of computer hardware and software equipment and the cleanliness of business premises.
Five, pharmacy pharmaceutical technicians in accordance with the provisions of certificates. All employees have purchased social insurance; Pharmacies strictly implement the national, provincial and state drug sales prices. When the insured purchases drugs, no matter which payment method is chosen, our store will implement the same price.
To sum up, in the past year, our hospital pharmacy strictly implemented the basic medical insurance policy and the "two-fixed" service agreement, and carefully managed the medical insurance information system; Respect and obey the leadership of the state and county social security management agencies, attend the study and meeting of social security organizations on time every time, and convey the spirit of superiors to every employee in time to ensure the implementation of the meeting spirit. In the future, our hospital pharmacy will continue to do a good job in drug quality, put an end to counterfeit and shoddy drugs and unhealthy practices, do a good job in drug supply for the insured people, and make greater contributions to the healthy development of medical insurance in our state.
2. The pharmacy self-inspection report
According to the special inspection notice and inspection standard of "Assured Pharmacy" of the Municipal Health Bureau and the US Food and Drug Administration, our hospital conscientiously implemented it and conducted a self-examination. Now the self-inspection results are reported as follows: 1. Strengthen management and clarify responsibilities.
Our hospital has set up a special pharmaceutical affairs management team, whose members comply with relevant regulations, formulated a pharmaceutical affairs management system, and held regular meetings. Strictly implement the regulations on drug bidding and purchasing, and apply for clinical use of new drugs.
The second is to strictly implement the system according to law, strict quality management, and ensure safety.
(a) the implementation of drug procurement system.
1. Legal channels: Our hospital strictly abides by the "Pharmaceutical Management Standards for Medical Institutions" and purchases drugs from legal enterprises with corresponding pharmaceutical business qualifications to ensure legal and safe drug channels.
2. Complete licenses: Before purchasing drugs, our hospital will verify the drug business license, business license, power of attorney of suppliers, and approval documents of purchased drugs.
3. Online centralized procurement: According to the instructions and requirements of the Municipal Health Bureau, our hospital has fully implemented online centralized procurement.
4. Bill management: every batch of drugs purchased by our hospital needs legal bills (tax bills and detailed lists) and keeps them.
(2) Implement the acceptance management system.
1. Drug acceptance: When accepting drugs, inspectors should not only check the drug name, specifications, approval number, quantity, batch number, expiration date, manufacturer and supplier, but also conduct sensory inspection on the appearance quality and packaging; The arrival of drugs must be accompanied by the factory quality report of the same batch number.
2. Acceptance of special drugs: double acceptance by the keeper and the inspector.
(three) the implementation of the storage and maintenance management system
1. Classified storage: the drugs in the drug storehouse are stored separately according to their nature and function. Expired and damaged drugs are placed in the drug return area. All of them are stored and managed in accordance with relevant regulations, stored in counters, recorded in special accounts, and the accounts are consistent with the materials.
2. Storage conditions: All drugs are stored according to the storage conditions indicated in the drug instructions.
3. Maintenance work: Drug maintenance personnel strictly implement the drug storage and maintenance management system, regularly check whether the conditions of drug protection from light, ventilation, fire, insects, rodents and pollution are reasonable, and establish corresponding maintenance files to ensure the quality of drugs.
4. Management of drugs approaching expiration date: We have established a management system for drugs with expiration date, and counted drugs on the 20th of each month, and removed the expiration date of drugs three months in advance to prevent the existence of expired drugs. Drug distribution also strictly follows the principles of "first in, first out" and "first out in the near future".
(4) Drug allocation and distribution system
1. Hygienic requirements for dispensing: the spoon, packaging and area of dispensing completely meet the hygiene requirements and the corresponding dispensing requirements.
2. Unpacking requirements: If it is necessary to unpack the original minimum packaging drugs, the words "Please take them within the specified service period" should be marked on the unpacked drug packaging bag, and the generic name, specification, batch number, expiration date and patient name of the drug should be marked.
(5) Reporting and monitoring of adverse drug reactions.
1, ADR monitoring: the pharmacy department is responsible for the collection of ADR reports. Check and urge clinicians to find and fill in adverse reaction reports from time to time, which will be summarized by the pharmacy department and reported to the superior drug supervision department online.
2. Clinical guidance: The Pharmacy Department provides guidance to clinicians through irregular visits to clinical departments.
Third, carefully organize and strengthen personnel training.
Strengthen system construction, actively carry out personnel training, and master relevant laws and regulations in a timely manner. Conduct regular training for all employees on the rational use of antibacterial drugs, and conduct regular training for doctors and pharmacists with prescription rights.
Through self-examination, we also found shortcomings, and we will improve and perfect our work to make our work more standardized. In short, in the future work, we will make unremitting efforts to provide patients with reliable drugs and quality services.
3. The pharmacy self-inspection report
A retail pharmacies can always adhere to the requirements of Drug Administration Law, GSP and its detailed rules, constantly strengthen drug quality management, and implement the principle of "quality first, business according to law". After active rectification, the drug quality management in the pharmacy of our hospital has been improved. First, the basic situation of pharmacies
Retail pharmacies are old shops that have been operating for many years. Its business model is drug retail. Its business scope includes prescription drugs and over-the-counter drugs: Chinese herbal pieces, Chinese patent medicines, chemical preparations and antibiotic preparations. At present, there are more than 800 kinds of Chinese and western medicines in pharmacies. Enterprises have always adhered to the service tenet of operating according to law and quality first in drug business activities for many years. There are 4 people in the pharmacy, including 2 pharmacists, 1 pharmacist. All the staff have many years of working experience in drug retail, established quality management system documents covering the whole process of GSP, and actively trained all the staff. Strictly control the service quality of drug procurement, acceptance, maintenance and sales, all quality management procedures meet the requirements, records are perfect, and after-sales service awareness is good.
The business place covers an area of 60 square meters and is equipped with facilities and equipment such as 1 air conditioner, 1 freezer, 1 computer, etc., which are used for drug maintenance, display and sales, prescription preparation, etc. It can meet the actual needs of daily drug management and deployment.
Second, all employees attach great importance to and fully perform quality management functions.
Our pharmacy has been ensuring the effective operation of the quality management system for many years. Full-time quality controller assigns and supervises quality management. While running the pharmacy quality system and guiding the quality management of each post, the quality controller can continuously strengthen the sense of responsibility and quality awareness of all employees and comprehensively ensure the quality of drug procurement and service. At the beginning of the year, pharmacies revised the quality management system documents of pharmacies. After years of system operation, the quality management system documents of pharmacies in our hospital are more standardized and operable. Through the implementation of relevant regulations, the job responsibilities of each post have been clarified again, and the drug quality information file has been completely supplemented; Drug quality files; Employee education and training files; Enterprise quality management system documents, etc. Ensure the orderly development of quality management of each post.
Our store usually attaches great importance to the quality education and improvement of personnel; On the basis of meeting the requirements of GSP post allocation, fully participate in the professional and technical training of all posts in Yamatonokusushi organized by the Municipal Medical Skills Training Center, and constantly improve the level of professional knowledge. At the same time, since the beginning of this year, the pharmacy in our hospital has carried out a comprehensive inspection of the maintenance facilities and equipment, and upgraded the computer to better ensure the daily management needs and meet the GSP requirements. Strictly classify and manage drugs in business premises, and make more scientific classification of drug use on the basis of prescription drug area, over-the-counter drug area, traditional Chinese medicine area, non-drug area, unqualified drug area and returned drug area.
Strictly implement the supplier customer review and the first enterprise approval system to ensure the legitimacy of suppliers and purchased drugs. Establish the files of qualified suppliers and customers of the first enterprise, and adhere to the principle of "quality first, business according to law"; Strictly implement the management system and process of the first enterprise. In terms of drug quality acceptance, our inspectors strictly implement the provisions of the acceptance management system, and carry out batch-by-batch acceptance of purchased drugs in accordance with the requirements of the drug acceptance regulations, and strengthen the acceptance management of imported drugs.
When displaying drugs, strictly implement drug classification management, standardize the requirements for drug placement and storage, and organize scientific classified display of drugs; Carry out maintenance work according to GSP requirements, and strengthen the maintenance inspection of key maintenance varieties, near-effective varieties and perishable varieties; Report the drugs suspected of having quality problems to the quality inspector in time; Play an active preventive role and ensure the quality of drugs. Doing a good job in drug sales and after-sales service is the foundation for the survival and development of our store. First, drug sales activities should be carried out in strict accordance with the business mode and scope approved by the license. Secondly, strictly follow the principle of "first in first out, first out in the near future" to ensure the accurate quantity and good quality of drugs sold; Before all drugs are sold, check whether the appearance quality of drugs meets the requirements and whether they are delivered according to the principle of near-expiration. In-store rational and safe drug use service consultation, guiding customers to master the correct usage and dosage. Pay attention to the collection of ADR information of drugs sold in this drugstore.
III. Self-inspection of GSP
After GSP certification is completed, our store will continue to implement full-time and whole-process drug quality management. Through the re-implementation of GSP certification, the mental outlook of pharmaceutical personnel in our hospital has been comprehensively improved, and the quality of personnel has been significantly improved. Now our pharmacy can meet the requirements of GSP in both software and hardware. For violations found in daily work, we can actively and seriously rectify them. Now self-examination is qualified!
4. Pharmacy self-inspection report
According to the requirements of relevant laws, regulations and rules such as the Drug Administration Law and the Quality Management Standard for Pharmaceutical Trading, in order to ensure the quality of drugs handled by our store is qualified and safe to use, our store has conducted self-inspection on relevant links of drug trading, and the self-inspection situation is as follows: 1. Personnel management:
1. In accordance with the requirements of laws, regulations and rules related to pharmaceutical business, our store has set up a quality leading group with the corporate as the main person in charge and the quality director as the main person in charge. At the same time, each store has full-time maintenance and quality management personnel, and the store has three employees.
2. According to the training requirements of drug-related management laws and regulations for enterprise employees, the person in charge of store quality management makes an annual training plan, trains store employees in laws and regulations and professional knowledge as planned, and establishes training files at the same time.
3. In order to ensure the quality and safety of drugs handled by stores, the business personnel and quality leaders who are in direct contact with drugs are examined once a year, and health records are established.
Second, facilities and equipment:
1. According to the relevant regulations and requirements of drug management, the business area of the store is 10000 square meters, and the color code management is strictly implemented in the store, with obvious signs.
2. The store is clean, tidy, dry and well ventilated, and there is no pollution source around. The store is equipped with facilities and equipment suitable for drug storage: air conditioner 1, mosquito killer 1, 4 mousetraps and thermometer 1.
Third, quality management:
The mall has established an adverse reaction monitoring and reporting system and a quality tracking and inspection system. In case of adverse events, the quality director will track, record and establish quality files according to the relevant quality management system.
Four. Sales management:
1. The store is engaged in business activities in strict accordance with the business scope and methods approved according to law, and has not changed the business premises, the person in charge of quality and other licensing matters without authorization, nor has it lowered the operating and storage conditions.
2, in strict accordance with the requirements of relevant laws, regulations and rules and regulations for drug sales.
The above is the self-inspection of our store in the whole drug business process, which has basically met the requirements of relevant laws, regulations and rules and regulations such as "Quality Management Standards for Drug Business".
5. Self-inspection report of pharmacy
Kangfutang Pharmacy was established in May of 20xx. It is an individual retail drugstore, and its business scope includes: Chinese patent medicines, chemical preparations, biological products, biochemical drugs and antibiotics. The address of the pharmacy is Dashizi, Qizil Town, Wensu County, with a business area of 43 square meters. There are nearly 265 kinds of drugs, all of which meet the requirements of laws and regulations stipulated by the state, and no counterfeit and inferior drugs have been distributed since its opening. Pharmacies adhere to the business tenet of "sincerely attracting customers, reputation first" and take GSP as the quality standard of enterprises. Since its opening, pharmacies have consciously carried out business activities in accordance with GSP certification requirements and strived to standardize quality management. Especially since the beginning of this year, I have studied the drug laws and regulations, GSP and its implementation rules, compared with GSP certification standards item by item, and made repeated self-examination and rectification, and achieved remarkable results. The quality management level of pharmacies has been greatly improved. Our store believes that it has basically reached the requirements of GSP certification standards at present. The implementation of GSP certification in our store is now reported as follows:
I. Institutional setup and staffing
The implementation of GSP involves the procurement, storage, sales and after-sales service of drugs, which is the management of all staff and the whole process. In order to ensure the smooth implementation of GSP certification, I am specifically responsible for the organization and quality management of GSP certification and the implementation of GSP certification. I am specifically responsible for implementing the quality management system of our store, as well as the management and audit of various quality management work and retail prescription audit to ensure the quality of drugs and services. I have obtained the post certificate through professional training according to the requirements of the post, and take part in the health examination regularly every year.
Second, pay attention to publicity, education and training.
In order to successfully implement GSP certification and improve my professional quality and quality awareness, I actively participated in post technical training, marketing technical training and GSP special study. The GSP special study covers laws and regulations related to drug business, knowledge of drug quality management, quality management system formulated by pharmacies, working procedures, quality responsibilities, etc. Through study and training, I have improved my professional quality and work skills, made me realize that GSP is a criterion that must be followed in drug business activities, and ensured the smooth implementation of GSP certification.
Third, improve the quality management system.
According to the requirements of the Drug Administration Law, the Quality Management Standard for Pharmaceutical Trading, and the GSP Certification Inspection and Evaluation Standard for Pharmaceutical Retail Enterprises, combined with the actual situation of our unit, I formulated the Pharmacy Quality Management System and the Drug Quality Control Procedure, which made me clear the post quality management regulations and made my work have rules to follow.
Fourth, increase investment in hardware and improve facilities and equipment.
In order to effectively implement GSP certification and improve drug management and storage conditions, our store purchased temperature and humidity control ventilation equipment suitable for its business scale; At the same time, it is equipped with shelves and mouse prevention equipment. The shop meets the requirements of dust-proof, moisture-proof, pollution-proof, insect-proof, rat-proof and mildew-proof.
Five, strictly control, strengthen the quality management of procurement, storage and sales.
In order to ensure effective quality management, pharmacies conduct comprehensive and systematic management of drug procurement, storage and sales, and track the whole process. At the same time, pharmacies have detailed and true records of the management of the whole business process, ensuring that the drug purchase channels are legal, the drug quality is qualified, and the management tracking is in place, effectively preventing the occurrence of various quality accidents. Since the pharmacy opened, there has been no distribution of counterfeit and inferior drugs, and there have been no adverse reactions and customer complaints related to drug quality.
Six, pharmacies in the process of drug procurement, storage, sales and after-sales service, specifically to do the following.
1, drug procurement
In strict accordance with the quality management system of pharmacies, strengthen the audit of supplier quality assurance system, require suppliers to provide copies of Drug Business License and Business License with official seals, establish supplier files, strengthen the qualification audit of supplier drug sales personnel, and sign quality guarantee letters with suppliers. Agreement; When purchasing imported drugs, suppliers are required to provide a copy of the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products and the Inspection Report of Imported Drugs stamped with the original seal of the supplier's quality management organization, so as to ensure good quality from the source.
2. Drug acceptance.
I check and accept the appearance, shape, packaging and label of drugs in strict accordance with the relevant laws and regulations, quality terms and quality standards of the contract, and resolutely refuse to accept those that do not meet the requirements.
3, standardize the management of drug display
In accordance with the requirements of GSP, pharmacies standardize the management of drug display, so as to place drugs according to their purposes. At the same time, drugs are stored separately from non-drugs, drugs for internal use and external use, and drugs that are easy to smell. Prescription drugs and over-the-counter drugs are stored in separate cabinets, and the signs are obvious and clear. Check the drugs on display every month and record them truthfully.
4. Pay attention to the maintenance of drugs.
I store and display drugs reasonably according to the quality management system of pharmacies and the storage conditions of drugs. I record the temperature and humidity of the business premises on time every morning and afternoon, and take timely control measures when the temperature and humidity do not meet the requirements of drug storage. At the same time, the general drugs in stock are inspected quarterly, and the key maintenance varieties are inspected monthly. The maintenance files of key maintenance varieties have also been established, and the maintenance records are true, perfect and standardized.
5. Do a good job in drug sales.
In order to standardize the behavior of the drug trading industry and provide consumers with reliable drugs and quality services, prescription drugs are audited by prescription, and other drug salesmen can insist on asking questions to achieve "three questions", that is, asking about the condition, gender and age, that is, explaining the administration method, dosage and precautions, and handing over according to the name, specification, quantity and price of the drugs purchased by customers. At the same time, pharmacies express the service convention in their stores, announce the supervision telephone number, and set up a customer suggestion book; And provide consulting services to guide customers to use drugs safely and reasonably.
Through the implementation of GSP certification, our management quality management system has been continuously improved; The level of business quality management has been continuously improved; The credibility has improved; Our store can continue to grow and develop. Of course, compared with the provisions and standards of the Quality Management Standard for Pharmaceutical Trading and its detailed rules for implementation, there are still some weak links in the quality management of pharmacies, which need to be further improved. Through this self-examination, we can basically meet the standard requirements of GSP certification. We urge the higher authorities to certify our store for the quality management standard of drug operation.