In a blink of an eye, a period of work has come to an end. Review the existing work problems during this period, make a summary and write a self-inspection report. How to focus the self-inspection report? The following is the self-inspection report of drug quality management (generally 5 articles) I collected for you, for reference only, and I hope it will help you.
Self-inspection report on drug quality management 1 According to the requirements of Measures for Drug Supervision and Management in Medical Institutions (Trial), our hospital carried out self-inspection on drug quality management in hospitals in 20XX, and now the results of self-inspection are reported as follows:
First, leaders attach great importance to improving management organizations.
Hospital leaders attach great importance to the drug management in our hospital, and set up a hospital pharmacy management team and a drug treatment management team, which are responsible for supervising and guiding the drug procurement and examination and approval in our hospital, scientifically managing drugs and rationally using drugs, and the pharmacy department is specifically responsible for drug deployment and drug quality management, with clear post responsibilities and serious implementation.
Two, strengthen management, establish and improve the drug quality management system and pharmaceutical work system.
The hospital has established and improved a number of management systems, such as the classification management system of antibacterial drugs, the work system of pharmacy department, the prescription checking system of pharmacy, the management system of drug procurement, the work system of drug maintenance, and the responsibilities of pharmaceutical personnel. Through the construction of these systems, the hospital has improved the level of drug quality management and pharmaceutical work.
Three, strengthen business knowledge training and learning, improve the professional quality of personnel.
The hospital organizes employees to study business every month, learn pharmaceutical laws and regulations and professional knowledge of pharmacy, conduct relevant examinations and tests, and establish training files, which further improves the professional skills and professional knowledge of employees.
Fourth, strengthen drug management and attach importance to drug quality.
Strictly implement the management regulations of the superior management department on drug procurement. The drug procurement of our hospital is through the centralized procurement platform of drug equipment in Guangxi Zhuang Autonomous Region. The drug procurement catalogue is determined according to the national essential drugs catalogue, the urban medical insurance catalogue, the basic drugs catalogue of the new rural cooperative medical system and the actual clinical use. It is reviewed by the hospital pharmacy management team and drug treatment management team, and approved by the hospital leaders. According to the procurement catalogue, the Pharmacy Department purchased the winning drugs on the centralized procurement platform of pharmaceutical equipment in Guangxi Zhuang Autonomous Region. Establish supplier files, strictly review the qualifications of suppliers and sales personnel, and ensure that they have legal information.
Enterprises purchase qualified drugs. In strict accordance with the management regulations of the superior health management department and drug supervision department, our hospital purchased medical devices from Guangxi Jianyi Pharmaceutical Co., Ltd., a pharmaceutical business enterprise with pharmaceutical business qualifications. The business license, drug business license, GSP certification certificate, original power of attorney of sales staff and copy of ID card of drug business enterprise were filed, and a drug quality assurance contract was signed. According to the Drug Administration Law and relevant drug laws and regulations, combined with the actual situation of our hospital, the relevant drug quality management system is formulated, including drug procurement, acceptance, maintenance system, prescription deployment and prescription management system, recent drug management system, special drug management system, adverse drug reaction reporting system, etc. The purchased drugs with special management shall be managed according to regulations, specially stocked, equipped with anti-theft and monitoring facilities, and managed by two people and two locks. The special account record is consistent with the account. The purchased drugs have a legal tax receipt and a detailed list of suppliers. The list contains the generic name, manufacturer, batch number, specification, quantity, price and other contents of the drugs. The purchase acceptance system is implemented, and the purchased drugs are accepted by two people, and a true and complete drug acceptance record is established. Drug acceptance records include generic name, manufacturer, specification, dosage form, batch number, expiration date, supplier, quantity, price, purchase date, acceptance date, acceptance conclusion, etc. The procurement and acceptance records of drugs and devices should be complete, and the issuer and recipients should be responsible for double signing, and the records should be available for reference. Implement effective storage management of drugs, warn drugs with a validity period of less than 6 months in the management system, and report them to various departments for promotion. Pharmacies and drug storerooms conduct daily inspection and maintenance of drugs, report the loss of expired drugs and medical devices once a month, go through the formalities of reporting the loss and destruction, make a good record of destruction, and double sign by the destroyer and the seller, and report the loss of expired drugs throughout the year 1 1 batch. Pharmacies and drug warehouses are equipped with air-conditioning equipment with temperature and humidity control, and refrigerators for storing related drugs can be stored according to storage requirements.
Five, strengthen the management of pharmacy.
According to the requirements of standardized pharmacy construction, drugs should be placed with obvious regional positioning signs, internal and external drugs should be stored separately, and drugs that are prone to odor should be stored separately. Maintain the displayed drugs every day, monitor the temperature and humidity, and take control measures in time if it exceeds the specified range. Pharmaceutical technicians who are qualified according to law are responsible for the examination and deployment of prescriptions. Pharmaceutical professional and technical personnel review, allocate, distribute and guide the safe use of drugs. Strictly implement the system of "four checks and ten pairs" when dispensing prescriptions to ensure the accuracy of drugs issued. The prescription shall not be changed without authorization, and the prescription with doubt, incompatibility and overdose shall be refused to be prepared, and it can only be prepared after being corrected or re-signed by the prescriber when necessary. Both the examiner and the distributor signed the prescription. Strictly implement the relevant provisions of prescription management, the prescription is valid on the day of issuance, and the dosage of prescription drugs generally does not exceed 7 days; Emergency prescription is generally not more than 3 days; Special prescriptions should be strictly used for special drugs, and drug prescriptions should be kept for 2 years. Check people who have direct contact with drugs every year and establish health records. Workers who have direct contact with drugs are not suffering from infectious diseases or other diseases that may contaminate drugs, and are in good health.
Six, seriously implement the adverse drug reaction monitoring and reporting system.
In 20XX, our hospital reported 8 cases of adverse drug reactions, with adverse drug reactions 1 case and 50 cases of drug abuse to the drug supervision department.
Self-inspection report on drug quality management 2 A Retail pharmacies can always adhere to the requirements of the Drug Administration Law, GSP and detailed rules for implementation, 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. The self-examination is as follows:
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 manage the classification of drugs in business premises, and carry out more scientific drug classification on the basis of prescription drugs, over-the-counter drugs, traditional Chinese medicine, non-drug areas, unqualified drugs and returned drugs.
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 in accordance with the requirements of the drug acceptance regulations, accept the purchased drugs batch by batch, 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!
Self-inspection report on drug quality management 3 In order to strengthen the standardized construction of drug quality management in our hospital, improve the overall level of drug quality management in our hospital, and ensure the safe and effective use of drugs, since June, the preparatory work has been fully carried out according to the "Guidelines for Inspection and Evaluation of Standardized Pharmacy in Medical Institutions in Laixi City" formulated by the US Food and Drug Administration. In order to meet the on-site acceptance of the higher regulatory authorities, we conducted a self-examination on the whole process of drug procurement, storage, deployment and use, from system construction to quality control. The self-inspection situation is summarized as follows:
First, leaders attach great importance to improving management organizations.
Our hospital has set up a pharmaceutical affairs management committee with the dean as the team leader, the dean in charge as the deputy team leader and the directors of relevant departments as the team members, which is responsible for supervising and guiding the drug quality management and rational drug use in our hospital. The pharmacy department shall set up drug quality administrators to be responsible for drug quality management, clarify the responsibilities of each post, and establish and improve various systems of drug quality management, including the responsibilities and inspection and assessment methods for the implementation of drug procurement, acceptance, storage and maintenance, special drug management system, refrigerated drug management system, prescription preparation and prescription management system, near-effect drug management system, adverse drug reaction reporting system and quality management qualification system; Procedures for procurement, acceptance, storage and maintenance of unqualified drugs.
Second, the quality management of drugs
1. The Pharmaceutical Affairs Management Committee of our hospital determined the drug procurement catalogue of our hospital according to the national essential drugs catalogue, urban medical insurance catalogue, rural cooperative medical care essential drugs catalogue and clinical use, and approved it. The pharmacy department will conduct online procurement according to the procurement plan.
2. In order to ensure the procurement of qualified drugs from legally qualified enterprises, establish qualified supplier files and strictly review the qualifications of suppliers and sales personnel; All purchased drugs have true and complete acceptance records; The purchased narcotic drugs and psychotropic drugs shall be managed according to regulations, recorded in special accounts, stored in counters, managed by two people and double locks, and equipped with anti-theft facilities; The implementation of drug validity management, the validity of less than 6 months of drug listing warning; Store drugs in strict accordance with their storage conditions and maintain them regularly. Ensure the quality of drug procurement and storage.
Three: pharmacy management
According to the requirements from the drug placement, maintenance, prescription deployment; Strictly implement the relevant provisions of prescription management; Every year, people who have direct contact with drugs are given health checks; Conscientiously implement the monitoring and reporting system of adverse drug reactions, have a special person responsible for information collection and reporting, and implement dynamic management of the "standardization" construction of pharmacies to ensure the quality and safety of drug use.
The responsibility of drug quality and management is great. Through self-examination, we will strengthen the following work in the next step:
1. Strengthen the management and use of high-risk drugs and antibacterial drugs.
4, strengthen the continuing education and training of pharmaceutical professional and technical personnel.
5. Strengthen the inspection, evaluation and review of the implementation of various management systems.
6. Seriously implement the reporting system of adverse drug reactions, closely monitor and report in time.
7, the establishment of information desk, suggestion box, take the initiative to provide drug consulting services to the public.
Through the establishment of "standardized" pharmacies, we will actively establish a "patient-centered" pharmaceutical service mode and carry out clinical pharmaceutical services with rational drug use as the core.
Self-inspection report on drug quality management: XXX pharmacy in 4 xx urban area, located in. XXX store in XXX district, with XXX in charge, business area of 200 square meters, * * * employees 10, and more than 4,000 business varieties. The business scope covers Chinese patent medicines, Chinese herbal pieces, chemical preparations, antibiotic preparations and biochemical drugs. Since its opening, there have been no illegal operations and no customer complaints, and the customers have responded well. In order to continue to strengthen and improve drug quality management in the future work, ensure the people to use drugs safely, reasonably and effectively, improve our image and ensure customers to buy drugs with confidence, our store conducts drug quality management in strict accordance with the Drug Administration Law, the Quality Management Standard for Pharmaceutical Trading and its implementation rules, and conducts self-inspection in accordance with the GSP Certification, Inspection and Evaluation Standard for Pharmaceutical Retail Enterprises.
I. Management responsibilities
Our store is engaged in drug business activities in strict accordance with the business mode and business scope approved by the Drug Business License, and all licenses are hung in prominent positions in pharmacies to facilitate supervision by the masses.
According to the characteristics and particularity of drug business, our store has set up a full-time quality manager with the title of pharmacist, who is given one-vote veto power, responsible for the daily management of pharmacies and the quality management and supervision of the whole pharmacy business activities, and regularly conducts vocational skills training and post personnel training for inspectors and maintenance workers. Set up part-time inspectors to be responsible for the quality inspection of all drugs in the whole pharmacy; A part-time maintainer was set up to be responsible for the drug maintenance of the whole pharmacy. The quality management system that complies with the Drug Administration Law, the Quality Management Standard for Pharmaceutical Trading and other laws and regulations is also suitable for the operation of our store, which institutionalizes the operation of the post, avoids the arbitrariness of "managing people with emotion" and ensures the continuity and operability of quality management.
Our store regularly inspects and assesses the rules and regulations in the quality management system, generally once every quarter, rewards and punishments are given to relevant personnel according to the inspection and assessment, and records are established. Conduct internal quality review once a year, generally from June 165438+ 10 to February 65438+February, and establish records.
There are 3 key projects and 3 general projects/kloc-0. All the key items of the self-examination and evaluation results have been achieved, and all meet the requirements except the general item (6006). Article (6006) The quality management organization or full-time quality management personnel shall be responsible for establishing the quality files of drugs handled by enterprises, including quality standards, etc. However, the quality of our store has not reached. We will implement the gradual improvement of specific personnel in the future work.
Second, personnel and training.
Our quality manager is a pharmacist and meets the requirements of GSP management. Testing personnel, maintenance personnel and sales personnel are all high school (technical secondary school) or above, reaching the GSP certification standard. All personnel have passed the physical examination of Xishan District Center for Disease Control and Prevention, and there are no infectious diseases, mental diseases and other diseases that may contaminate drugs, and they hold health certificates. At the same time, employee files and health files were established.
All employees in our store must pass the training and examination of drug supervision and management before they can take up their posts. Quality managers will regularly conduct on-the-job training and evaluation according to our shopping mall system. And established training files.
There are 4 key projects and 8 general projects. The key projects have been fully achieved, and the general projects have been fully achieved.
Three. Facilities and equipment
Our store covers an area of 200 square meters, with 5 1 counter * * * 6 1 meter, which meets the requirements of drug display. According to the principle of "four separation", it is divided into non-drug area and drug area, and drugs are divided into prescription box, over-the-counter drugs for external use, drugs for internal use and drugs that are easy to smell. Business shelves and counters are complete, sales cabinets are marked with eye-catching signs, the storefront environment is clean and sanitary, and the ground is flat. The pharmaceutical business is all managed by computer, and equipped with a thermometer that has passed the inspection by Kunming Municipal Bureau of Technical Supervision. Dust-proof tools, moisture-proof articles, insect-proof articles and rat-proof articles are complete and work normally, reaching the requirements of GSP standard.
There are 3 key projects and 10 general projects. There are 2 key items (other 680 1 items are reasonably missing) and 7 general items (other 6705, 6807 and 6808 items are reasonably missing).
IV. Purchase and Acceptance
Our buyers strictly follow the principle of "purchasing on demand and selecting the best", and buy drugs from legal enterprises with strong strength and complete varieties certified by GSP. Bills are legal, so that tickets, accounts and goods are consistent. Check the product name, approval number, manufacturer, specification, batch number, expiration date, production date, instructions, packaging and appearance quality according to the quality management system procedures, and make records to reach GSP.
There are 9 key projects and 4 general projects/kloc-0. Seven key items (other 7007 and 7002 items are reasonably missing) and general 13 items (other 7504 items are reasonably missing).
Verb (abbreviation of verb) display and maintenance
Drugs are displayed according to the principle of "five points" and classified according to efficacy. Drugs are placed without labels, stamped up and down and crossed left and right. The old batch number is placed before the new batch number, and the goods are delivered in strict accordance with the principle of "first in, first out". Record the temperature and humidity on time every morning and afternoon, and take timely measures when it is found that it is out of range, so as to ensure that the environment of the displayed drugs meets the requirements, regularly check the quality of the displayed drugs and make records, report the problems found in the inspection to the quality administrator in time, handle them according to GSP requirements and make records.
There are 8 key projects and 6 general projects/kloc-0. There are 7 key projects (another 7707 projects are reasonably missing) and 12 general projects (another 7706, 7709, 7804 and 790 1 project are reasonably missing).
Intransitive verb sales and service
Sales staff introduce the performance, use, contraindications and precautions of drugs to customers according to the drug instructions. The sales of prescription drugs can only be sold after being audited by personnel with pharmacists' technical titles, and the sales records of prescription drugs should be kept for two years for future reference. We have set up a service agreement, a supervision telephone number and a customer consultation letter in a prominent position in the pharmacy. We will seriously deal with the valuable opinions put forward by customers and give timely feedback.
Drug quality management self-inspection report 5 is to implement the quality inspection of drugs and medical devices in our hospital by the flag food and drug administration, ensure the safe and effective use of medical devices by the people, and standardize the use and management of drugs. The hospital set up a self-examination team headed by the dean. According to the Notice on Effectively Strengthening the Safety Management of Drugs and Medical Devices in Medical Institutions at All Levels, the Drug Administration Law, the Quality Management Standard for Drug Use and the Specification for Pharmacy issued by the Health Bureau of Xiwuqi, the self-inspection team has done a lot of detailed self-inspection, and now the self-inspection report is as follows:
I. Institutions, personnel and systems:
Our hospital has legal qualifications such as practicing license of medical institutions. A drug quality management organization was established, which was composed of the director, the head of pharmaceutical machinery department, the head of pharmacy, the head of quality and the buyer, and the responsibilities of personnel and organizations at all levels were defined. At the same time, various quality management rules and regulations have been formulated as a guarantee and carefully organized and implemented. At the same time, the Pharmaceutical Affairs Management Committee of our hospital and the supervision and guidance group for clinical rational use of antibacterial drugs have been established and improved.
Our hospital has established a continuing education and training plan. The training focuses on People's Republic of China (PRC) Drug Administration Law, Regulations on Pharmaceutical Affairs Management of Medical Institutions, Regulations on Supervision and Management of Medical Devices, Guiding Principles for Clinical Application of Antibacterials, Measures for Management of Clinical Application of Antibacterials, Measures for Prescription Management, Special Remediation Activity Plan for Clinical Application of Antibacterials in Inner Mongolia Autonomous Region in 20xx, and other laws and regulations, the basic theory of national drugs and medical care, and the relevant regulations on strengthening supervision and management of medical devices and storage. Improve the quality of personnel, further standardize all aspects of drugs and medical devices from procurement, acceptance and storage, storage and use, and strictly follow the regulations. Every year, people who are in direct contact with drugs are examined for health, and health records are established to ensure the safety and effectiveness of drug use.
Second, the procurement and acceptance:
Purchased drugs in strict accordance with the centralized drug procurement system formulated by the superior health bureau. Purchasing drugs from enterprises with pharmaceutical production and business qualifications; The acceptance of drugs in storage shall be carried out in strict accordance with the standard operating procedures, and the quality of drugs purchased and returned after sale shall be accepted batch by batch in strict accordance with the statutory quality standards and contract quality terms.
Three, the implementation of standardized pharmacy management system:
In strict accordance with the standard of standardized pharmacies, the Meng Xi pharmacies and drug storerooms in the whole hospital are managed.
Four, drug storage and maintenance:
The warehouse is divided into drug warehouse and medical device warehouse, and each warehouse is divided into qualified area, pending inspection area and unqualified area. Each area is managed according to the regulations, that is, the qualified area is green, the returned area to be inspected is yellow, and the unqualified area is red. After the acceptance, the special drug warehouse should be stored in strict accordance with the drug storage and maintenance system, and stored in the corresponding reservoir area according to the drug storage conditions and requirements. Drugs should be piled up in a centralized way according to the batch number and expiration date, or stacked separately according to the order of batch number and expiration date, and drugs near the expiration date should fill in the expiration date table every month.
Five, the deployment of drugs:
Pharmacists must prepare drugs with prescriptions issued by registered medical practitioners, and drugs may not be prepared without prescriptions issued by doctors. Drug preparation should be carried out in strict accordance with the requirements of four checks and ten pairs, and distribution should follow the principles of "production first, distribution first", "distribution first in the near future" and distribution according to batch number.
Six, adverse reaction monitoring:
Establish an adverse drug reaction monitoring and management team, designate full-time or part-time personnel to be responsible for reporting and monitoring adverse drug reactions, establish and save adverse drug reaction monitoring files, actively collect adverse drug reactions, and report them through the national adverse drug reaction monitoring information network. The contents of the report shall be true, complete and accurate.
Seven, special drugs:
Special management drugs have safe storage measures that meet the requirements, and five special management methods are implemented, such as double locks for two people and matching accounts and goods. The purchased special drugs shall be accepted upon arrival, unpacked by two persons, counted according to the minimum package, and special acceptance records shall be kept. The returned, expired and unqualified specially managed drugs and wastes recovered according to regulations shall be destroyed under the supervision of the health department, and the destruction records shall meet the requirements.
Eight, problems found in the inspection:
Through the self-inspection team, all aspects of hospital drug use and quality management were self-inspected, including personnel organization, management system, hardware facilities, management records, etc., which basically met the requirements of drug use quality management norms. However, we also found some shortcomings, such as poor sanitary conditions, irregular drug placement, irregular classification, unclear zoning, and insufficient written records in some places involving medical equipment. Ordered the relevant personnel of all departments to seriously rectify according to the system and implement it to people.
Nine, rectification:
On the basis of self-examination and mutual inspection, our hospital respectively rectified the following problems:
1. Formulated the system and labels of confusing drugs, and attached them next to the classified confusing drugs.
2. Formulated the on-the-job education and training system and training plan focusing on ethnic medicine.
3. The system of medical device incoming inspection record is established.
4. The monitoring system of medical device adverse events was established.
5. Strengthen the maintenance of large medical equipment. Supplementary medical device inspection, maintenance and related records will be implemented for a long time.
6. Strengthen the monitoring of adverse reactions and medical device adverse events.
In actual work and implementation, there may be some subtle problems that are easily overlooked. I hope the superior leaders will put forward valuable opinions on our work. In the future work, we will make persistent efforts to do a better job in pharmaceutical affairs in our hospital and ensure the safety of people's medication.
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