1 in 2023, a report on self-inspection of pharmacies has been subjected to strict internal audit and self-inspection in accordance with the "Evaluation Criteria for Inspection and Acceptance of Veterinary Drug Management Standards in * * Province". The self-inspection is as follows:
I. Basic information of the enterprise
1. Enterprise Nature: * * * * * Livestock and Poultry Pharmaceutical Service Center was established in * * *, and it is an enterprise specializing in the wholesale and retail of veterinary drug preparations.
2. Geographical location: * * * * * Livestock and poultry medicine service center is located in * * * * * * * *
3. Business scope and varieties: veterinary drug preparations and 15 products. All products are produced by veterinary drug production enterprises that have passed GMP certification of the Ministry of Agriculture, and each product is produced in strict accordance with national legal quality standards. The products sold in the market are guaranteed not to contain drugs prohibited by national laws and regulations, and are safe and effective to use. The products sold in the market have passed the inspection by the Provincial Institute for Drug Control, obtained the product approval number, standardized packaging instructions and qualified product quality.
4. The construction and management of this center fully meet the requirements of GSP.
5. Quality management organization: the quality management organization of the center is sound, headed by the general manager, and the quality leading group composed of quality management leaders, buyers and personnel in various positions is responsible for the overall quality management and quality system audit of the center, which can better perform quality management functions. Each post can conscientiously implement policies and objectives, and implement various quality management systems and operating procedures.
6. Staffing: There are * * employees in the center, including * * undergraduates who graduated from agricultural universities, most of whom have been engaged in this major for * * years or more.
Second, the GSP quality system self-inspection summary
Since the opening of 1 and * * * * Livestock and Poultry Pharmaceutical Service Center, management posts have been set up in strict accordance with the spirit of relevant documents from higher authorities and the Regulations on the Administration of Veterinary Drugs and the Regulations on the Administration of Veterinary Drugs. At present, various quality management systems, post quality responsibility system, quality management procedures and quality table records have been formulated, and a quality assurance system for the whole process of veterinary drug procurement, acceptance, maintenance and sales has been established, so that every link of veterinary drug management can be followed by rules.
2, enterprise personnel and training.
* * * * According to the annual training plan of the enterprise, all the staff of the Livestock and Poultry Pharmaceutical Service Center have received professional technical training and assessment such as the Regulations on the Administration of Veterinary Drugs, the Regulations on the Administration of Veterinary Drugs and the quality management system, and established employee training files. After passing the training, they will take up their posts. All employees who have direct contact with veterinary drugs have undergone physical examination and established employee health records. ( ZWB5.COM )
3. Facilities and equipment
The business hall is equipped with a thermometer to record the temperature and humidity every day and control the business environment. Each warehouse is equipped with exhaust fans for ventilation, flying lights and mousetraps at the door, and each warehouse is equipped with fire extinguishers. Among them, there are air conditioners and thermometers in the cold storage room, which record the temperature and humidity every day. Every warehouse has enough pads, and all veterinary drugs are stored off the ground. Veterinary drug varieties are divided into areas according to dosage forms and uses, stored in warehouses and managed by color codes. Each variety has a positioning card, and the status and quantity are clear at a glance. These can meet all the needs of existing varieties.
4, veterinary drug procurement management
* * * * In order to ensure the quality of veterinary drugs, the Livestock and Poultry Pharmaceutical Service Center has formulated a veterinary drug procurement management system and a first order business management system. Follow the principle of "taking quality as the premise, purchasing on demand and selecting the best". Ensure that the supplier's legal qualification and quality reputation must be reviewed first when purchasing goods, and the legality and quality reliability of purchasing veterinary drugs must be reviewed. All purchased veterinary drugs have legal bills.
Complete procurement records shall be established and filed as required, and all records shall be kept as required.
5, veterinary drug quality acceptance management
* * * * The full-time quality inspector of the Quality Control Department is responsible for the acceptance of veterinary drugs in the Livestock and Poultry Pharmaceutical Service Center. Veterinary drug acceptance records shall record the supplier, quantity, arrival date, product name, dosage form, specification approval number, batch number, manufacturer, validity period, quality status, acceptance conclusion and acceptance personnel. Establish a complete acceptance record and file it as required.
6, display and maintenance
Veterinary drugs require the basic principle of separating prescription drugs from over-the-counter drugs according to the classification of GSP. Put the corresponding shelves separately, and put them correctly and accurately. The administrator shall, according to the veterinary drug maintenance management system, conduct a periodic maintenance inspection on the veterinary drugs stored in the warehouse once a month. The main contents of inspection include packaging, appearance, shelf life, etc. And strengthen the maintenance and management of veterinary drugs that are perishable, long in display time and short in validity. Veterinary drugs with a validity period of nearly 3 months should be filled in in time and sold first. Veterinary drugs that exceed the validity period should be returned to the library in time.
7. Sales and after-sales service
* * * * The salesmen of the Livestock and Poultry Pharmaceutical Service Center implement unified and standardized management according to the quality management system of veterinary drug sales and related operating procedures, and can correctly introduce the performance, uses, taboos and precautions of veterinary drugs, without misleading users, provide correct and reasonable medication guidance and consulting services for consumers, and check the names, specifications and quantities of veterinary drugs purchased by customers before selling them.
* * * * The Livestock and Poultry Pharmaceutical Service Center has a supervision telephone and a customer suggestion book, which widely collects quality information, customer opinions and quality complaints, and gives feedback on the quality problems of veterinary drugs and service quality reflected by customers.
Take the detailed records seriously, follow them up, explain everything and answer every pile.
8. Management of unqualified veterinary drugs
* * * * Up to now, there are no unqualified veterinary drugs in the Livestock and Poultry Pharmaceutical Service Center, but the system has established regulations on reporting, confirmation, loss reporting and destruction of unqualified veterinary drugs, and made records to effectively control unqualified veterinary drugs and prevent unqualified products from entering the market.
9, file system and quality management
In order to ensure the quality of veterinary drug management, the center has formulated a series of feasible quality management systems according to the national laws and regulations on veterinary drugs and the requirements of GSP, combined with the actual needs of enterprise management. Since the implementation, the operation and management activities of the center have been more scientific and standardized, the responsibilities and work requirements of each post have been clearly defined, and the overall quality management level of the center has been continuously improved and improved. The above is the implementation of GSP in * * * * Livestock and Poultry Medicine Service Center. Because this is the first time, we have little experience to learn from, and our level is limited, so it is inevitable that there are deficiencies and irrationalities. I hope the experts can put forward valuable opinions to help us improve our work in the future, better implement the "Quality Management Standards for Veterinary Drug Management" and make better contributions to the veterinary drug circulation industry. thank you
2023 Self-inspection Report of Pharmacy 2 Kangmei Pharmacy in Dianjiang County, according to the requirements of Dianjiang County Human Resources and Social Security Bureau, according to the spirit of Notice on Carrying out Special Inspection of Designated Service Institutions of Work-related Injury and Maternity Medical Insurance (Yu She Fa [20xx] No.99) and Notice of Chongqing Social Insurance Bureau on Implementing the Special Inspection of Designated Service Institutions of Work-related Injury and Maternity Medical Insurance by the Municipal Human Resources and Social Security Bureau and other six departments (Yu She Fa [20xx] No.49)
Basic information: our store hangs the certificate of designated retail pharmacy, and announces the service promise and social security complaint telephone number according to the regulations; Business license, drug business license and certificate of quality management standard for drug business are all within the validity period; Submit the Self-evaluation Form of Designated Pharmacy Service on time every quarter; The drugstore * * * has 3 clerks, including/kloc-0 pharmacists and 2 salespeople, all of whom have signed labor contracts and participated in social insurance as required. In the process of self-examination and self-correction, we found some good points and some shortcomings.
What you did well:
(1) Strictly abide by the Drug Administration Law of People's Republic of China (PRC), and strictly implement the relevant regulations on medical insurance credit card management; (2) Seriously organize and study the medical insurance policy, correctly publicize the medical insurance policy to the insured, and did not sell any other items that did not meet the payment scope of the medical insurance fund; (3) The clerk actively and enthusiastically serves the insured and does not sell counterfeit and inferior drugs. So far, no complaints have occurred; (4) The store shall be clean and tidy, strictly implement the national drug price policy, and clearly mark the price.
In 2023, the self-inspection report of Pharmacy 3 was notified by XXXXXX, and the pharmacy paid more attention to it. According to the national Food and Drug Administration Law and GSP management norms, the self-examination and self-correction are reported as follows:
1. Our store was established in, and it is a chain store of a pharmaceutical company. It is a pharmaceutical retail enterprise in nature and passed GSP certification in.
2. Strengthen leadership, organize drug-related personnel to concentrate on learning, understand the spirit of the document, and operate in accordance with the Drug Administration Law of People's Republic of China (PRC) and other relevant laws and regulations.
3. In terms of business scope, there is no out-of-scope operation. All drugs in our store are within a reasonable range, and there are no drugs prohibited by the state from being sold. Uniformly purchase goods from regular drug suppliers (such as XXXXXX Sales Co., Ltd.), do not purchase goods from illegal channels, ensure the quality of drugs, and do not deal in counterfeit and inferior drugs.
4. Personnel and training. According to the training plan of specific shop assistants, employees are trained in relevant laws, regulations and rules such as drug administration law, quality management system and business knowledge, and employee education files are established.
5. Maintenance, display and storage of facilities and equipment, such as adjustment of wet thermometer, measurement inspection, dehumidification of air conditioner, cleaning of mosquito and fly lamp, etc. Maintenance of refrigerator. Save the maintenance records according to the date.
6, drug maintenance, purchase acceptance and maintenance, according to the professional training acceptance and maintenance. Check the specification, dosage form, manufacturer, approval number, registered trademark, expiration date and quantity, label description and related documents of drugs, make records and place drugs in categories. If prescription drugs and over-the-counter drugs are found to be unqualified, they shall be corrected in time, and the drugs shall be maintained and inspected, and records shall be made.
7, drug sales and services, pharmacies to quality service first, sales staff health examination qualified certificates, enthusiastic service to customers, wearing a badge and name service. Don't mislead consumers when introducing drugs, and explain the contraindications and precautions to consumers. When the drugs sold in our store are sold according to the relevant regulations, prescription drugs can only be sold with prescriptions issued by licensed pharmacists or professional pharmacists' assistants.
In short, through this self-examination, we take the inspection as an opportunity, seriously rectify and work hard, and we will understand the purpose of the document in strict accordance with the spirit of the instructions of the county bureau, so as to satisfy customers and let everyone eat safe, effective and assured drugs. All the staff of the pharmacy thanked the leaders of the Municipal Food Administration for their seriousness in their work. I hereby pay tribute.
Hereby report
2023 pharmacy self-inspection report 4 Dear inspection team experts and leaders,
Good afternoon, welcome all experts and leaders to visit and guide our company! Below I will give a brief report to the experts and leaders on the basic situation of implementing GSP in this enterprise:
1. Company Profile: Haifeng Veterinary Feed Store is a private veterinary feed retail enterprise. Founded in June 20xx, the registered address is Enhe Street, Enhe Town, Zhongning County, and the legal representative is Chen Haifeng. At present, * * * has a total of 3 employees, all of whom have reached technical secondary school education in veterinary specialty. The area of pharmacy business premises is 30m2, and the area of warehouse is 40m2. The business scope of pharmacies includes: veterinary chemicals, traditional Chinese medicine preparations, pesticides, feed additives, etc., operating more than 30 kinds, with an estimated annual sales of 65,438+10,000 yuan. In the preparation stage of veterinary drug GSP in recent months this year, the recent cost of software, hardware and environmental transformation is about 13000 yuan. Since its establishment, our enterprise has always adhered to the principle of "serving farmers, quality first" in the process of veterinary drug management, comprehensively implemented the Regulations on Veterinary Drug Management, Standards for Quality Management of Veterinary Drug Management and other laws and regulations, strengthened basic management, constantly improved various quality management systems, ensured that all quality management systems were implemented, strengthened employees' awareness of veterinary drug quality, improved their professional quality, constantly improved the quality management level of veterinary drug management, and legally engaged in veterinary drug management activities. In recent months, the enterprise has not had a veterinary drug quality accident, which has been affirmed and praised by the majority of farmers. In the process of GSP inspection and acceptance, the enterprise will foster strengths and avoid weaknesses, learn with an open mind, and strive to do a good job in veterinary drug management to meet the needs of breeding customers to the greatest extent.
Two. Implementation of veterinary drug GSP: In recent months, according to the provisions of this veterinary drug GSP standard and its detailed rules for implementation and the requirements of the Grading Standard for Veterinary Drug GSP Acceptance Site Inspection Items, our company has carried out many inspections on the implementation and rectification of veterinary drug GSP management, and timely corrected unqualified items. The following summarizes the latest self-inspection and rectification from seven aspects:
1, establishment of quality management organization for veterinary drug management and formulation and implementation of quality management documents. Because the enterprise is located in a township, and the breeding scale in this area is small, there are few users and few merchants, and the quality management has 1 person, which is responsible for quality supervision, quality management and quality acceptance. Since August this year, our veterinary drug store has formulated a set of quality management documents suitable for its own actual situation according to the requirements of veterinary drug GSP. In the course of operation, our pharmacy strictly follows the requirements of GSP. according to
During the trial operation required by GSP specification, some systems were not well implemented, and the work was not standardized. After many rectifications, the system has been fully implemented and basically meets the requirements of GSP specification.
2. Personnel and training. (1) personnel composition: general manager (quality manager) of our pharmacy: Chen Haifeng, male, aged 3 1, graduated from veterinary animal medicine; Salesman (and warehouse keeper) Chen, male, 63 years old, graduated from veterinary major and has been engaged in grass-roots animal husbandry and veterinary work for a long time; Buyer Zhu, male, 42 years old, graduated from animal husbandry and veterinary specialty, and all the above personnel have been trained and assessed by the county competent department to obtain employment certificates; (2) Training situation. Our veterinary drug store began to make an annual training plan when GSP was rectified, and the plan contained detailed training contents. The training method is mainly based on the combination of pharmacy's own centralized training and higher-level department training. Our own training method is: focus on two days of spare time every month to learn business knowledge and laws and regulations on veterinary drugs promulgated by the state, and take an exam on the main contents, and the exam results are linked to wages, so as to mobilize and stimulate employees' learning enthusiasm. And actively participate in the training of veterinary drugs and veterinary knowledge organized by higher authorities, and through effective use of various ways to learn, the professional quality has been greatly improved. The staff of our veterinary drug feed store had a health check-up on time this year, and the health check-up files were complete and the standards met the requirements.
3. Facilities and equipment. This veterinary drug store has a business space of 30㎡ and a warehouse area of 40㎡. The business area, environment and layout meet the requirements of veterinary drug GSP. The main facilities and equipment are: office area 1 desk, business area 1 filing cabinet, 1 computer, 1 laser printer, 1 cabinet air conditioner, 4 sets of aluminum alloy shelves and 2 sets of glass counters; 5 warehouse mats, 3 shelves, 1 wall-mounted air conditioner (for cool warehouse); 3 wet and dry thermometers (business room 1 unit, normal temperature room 1 unit, cold storage 1 unit); In addition, there are fire extinguishers, 3 rat-sticking boards, 1 fly-killing lamps and sanitary cleaning tools in the business area. Equipment and facilities can meet the needs of daily business activities.
4. Veterinary drug procurement management. In the management of veterinary drug procurement, the procurement procedures of veterinary drugs are strictly implemented to purchase from qualified legal enterprises, and the first-time enterprises conduct review and approval according to the management system of the first-time enterprises, and sign quality assurance agreements and product supply contracts with suppliers. Purchase invoices shall be kept in good condition, so that tickets, accounts and goods are consistent. Establish qualified supplier files.
5, veterinary drug inspection and acceptance management. The drug management of our veterinary drug store is the responsibility of the quality administrator who has obtained the training certificate. In the work, each batch of purchased veterinary drugs should be carefully checked and accepted from the packaging to the appearance of veterinary drugs, and each batch of purchased veterinary drugs should be logged into China Veterinary Drug Information Network at any time.
Check the products and return the unqualified or suspicious veterinary drugs after confirmation. Up to now, our veterinary drug store GSP has accepted more than 50 batches of veterinary drugs, and the qualified rate of veterinary drugs in storage has reached 100%.
6, drug storage, maintenance and display (retail) management. During the rectification of GSP, our veterinary drug store created a high-standard storage and display environment, customized glass counters and added new shelves, and equipped the warehouse and business hall with air humidity and thermometers. Once it is found that the storage requirements cannot be met, corresponding measures shall be taken immediately. In our work, we will manage according to the Management System for the Storage, Maintenance and Display of Veterinary Drugs, such as the separate display of veterinary drugs and feed additives, the separate display of powder injection and water injection, and the management of storage color codes. Set the signs of the area to be inspected (yellow), qualified area (green), unqualified area (red) and returned area (yellow) as reasonable standards. In addition, measure the temperature and humidity of the business hall and warehouse every day, and take timely measures to adjust when it does not meet the requirements; Do a good job in daily hygiene and cleaning, regularly check the maintenance of inventory and display drugs every month, and keep complete records. These measures can ensure the storage quality of veterinary drugs.
7. Sales and after-sales service. Carry out business activities in strict accordance with the requirements of relevant systems in terms of sales and after-sales service. The sales records of veterinary drugs are accurate and complete; The management responsibility of complaints and adverse reaction reports lies with people, and related work is carried out in an orderly manner. In sales work, salespeople are required to dress neatly, wear badges indicating their names and job responsibilities, use civilized language, set up suggestion books to welcome customers to put forward valuable opinions, and set up customer rest areas to create a comfortable, comfortable and relaxed environment for customers to buy drugs in their business premises.
With the intensification of market competition and the strengthening of veterinary drug supervision and management, the new quality management standards for veterinary drug management put forward higher requirements for the quality management of veterinary drug management enterprises. We are determined to improve and standardize the quality management in the GSP certification process. After self-examination of the above aspects, the enterprise thinks that it has basically reached the requirements of the GSP construction specification for veterinary drugs. Please ask the leaders and GSP inspection team to accept and put forward valuable opinions. Our enterprise must accept it with an open mind and try to correct it.
Haifeng veterinary medicine feed Dian
October 29th, 20 10
Report on self-inspection of pharmacies in 2023 5 xx Municipal Bureau of Human Resources and Social Security: In order to further strengthen and standardize the management of designated retail pharmacies with basic medical insurance for urban employees, according to the Interim Provisions on Basic Medical Insurance for Urban Employees in xx and other relevant regulations, our pharmacy signed a medical insurance service agreement with the medical insurance department of xx in contrast to the Administrative Measures for Designated Retail Pharmacies with Basic Medical Insurance for Urban Employees in xx. In the course of service, we failed to provide good services according to the requirements of various regulations, which caused losses to social medical insurance and brought some negative effects. To this end, he was sentenced to six months' suspension and rectification. Now that the rectification period has ended, we have completed the rectification as scheduled, and guarantee that the following behaviors will not occur in future operations:
1, don't check the social security card, don't make (sell) drugs according to the prescription;
2. Drugs, daily necessities, health care products or other items in the drug list of employees' basic medical insurance;
3. Provide medical insurance settlement services for non-designated retail pharmacies;
4. Providing personal account realization services for the insured;
5. Stealing funds from the personal account of the insured;
6 other acts of taking medical insurance funds.
Through the above summary, the operation of this pharmacy has reached the requirements of fulfilling the medical insurance service for urban employees and the requirements of continuing to fulfill the medical insurance service agreement for employees' lives. Please correct me if there are any imperfections, and we will accept and correct them with an open mind.