Part I GSP internal audit self-examination report
xx medicine store was established in 200x x month x, is an individual retail enterprise, the business scope includes: Chinese medicine Chin tablets, proprietary Chinese medicines, chemical pharmaceutical preparations, antibiotics, biochemical products, biological, store address for xx town xx, business premises xx square meters, warehouse area xx square meters (all cool storage). Warehouse area of xx square meters (all cool storage), refrigerator effective volume of 189l. Since the opening of sales of nearly x million yuan, gross profit of xx yuan. The operation of nearly xxx kinds of drugs, all business behavior are in line with national laws and regulations, since the opening of no distribution of fake and shoddy drugs.
The pharmacy adheres to the "sincerity of the customer, reputation first" business for the purpose of gsp as the enterprise quality standards, the pharmacy opened in accordance with the gsp certification requirements consciously carry out business activities, and strive to make the quality management work standardized. Especially this year, we through the drug laws and regulations and gsp and its implementing rules of continuous learning, article by article, item by item against the gsp certification standards, repeated self-checking and rectification, received a significant effect, the level of quality management of the pharmacy has substantially improved the level of quality management, we believe that the current has basically reached the gsp certification standards, the implementation of the gsp certification of the work of the store is now reported as follows:
First, the organization set up and staffing
gsp implementation involves the purchase of drugs, storage, sales and after-sales service and other aspects of the management of the whole person, the whole process. In order to ensure the smooth implementation of gsp certification, the person in charge of the enterprise is specifically responsible for the gsp certification organization and coordination, and at the same time equipped with the enterprise quality officer, specifically responsible for the enterprise quality management and organization of the implementation of gsp certification. Enterprise existing staff x people, pharmacy professional and technical personnel x (pharmacist), the quality of the person in charge of the pharmacist, specifically responsible for the implementation of the enterprise quality management system and business management process of the quality management work of the management and audit and retail prescription audit work, to ensure the quality of medicines and services, all employees are in accordance with the requirements of the induction after professional training to obtain a certificate, in addition to the pharmacy each year to organize regular staff to participate in health check-ups, and for each employee to establish a health file, and the health of the staff. In addition, the pharmacy regularly organizes health checkups for its employees every year and establishes a health file for each employee to ensure that those who are qualified in health checkups will be employed in jobs that have direct contact with medicines. At present, the pharmacy staffing is more reasonable, in line with the gsp certification requirements.
Second, pay attention to publicity and education and training work
In order to successfully implement the gsp certification work, improve the professional quality of staff and quality awareness, the preparation of training plans through a combination of internal and external training, has organized the relevant personnel to participate in the post of technical training, marketing technology training and gsp special learning, gsp special learning content involves the relevant laws and regulations of the drug business, The gsp special learning content involves the relevant laws and regulations of drug business, knowledge of drug quality management and the quality management system, work procedures, quality responsibilities and so on developed by the pharmacy. Through the study and training, greatly improve the professional quality of the staff and job skills, so that employees realize that gsp is the drug business activities must follow the guidelines to ensure the smooth progress of the gsp certification work and put into practice.
Third, improve the quality management system
According to the "Drug Administration Law", "Drug Administration Quality Management Standard" and "Drug Retailers gsp certification inspection and evaluation standards" requirements, combined with the actual situation of the enterprise itself, the pharmacy quality person in charge of the organization of the relevant personnel to develop the "Pharmacy Quality Management System", "quality of all levels of personnel responsibilities", "drug quality control procedures", so that each employee is clear about the quality of each position. In order to make every employee clear about the quality management regulations of each position, so that the work can be followed by rules and regulations. Pharmacy quality responsible group according to the provisions of the system, every six months on the implementation of the system for assessment, found that the problem, immediate rectification, timely correction.
Fourth, increase hardware investment, improve facilities and equipment
In order to effectively implement the gsp certification, improve the drug business and storage conditions, the store purchased with the scale of operation of the refrigerator, air conditioning, exhaust fans, such as temperature and humidity control ventilation equipment; at the same time configured shelves, and additional rodent-proofing equipment, so that the warehouse to achieve a dust-proof, moisture-proof, anti-pollution and insect-proof, rodent-proof, anti-mold requirements. Requirements, the warehouse area has fire safety equipment. At the same time, the pharmacy on the warehouse partition management, color coding is obvious, so that the warehouse division of the four districts in line with the requirements of the gsp.
Fifth, strict control, strengthen the purchase, storage, sales quality management
To ensure that the quality management work effectively in place, the pharmacy on the purchase of drugs, storage, sales and other aspects of the comprehensive and systematic management, the whole tracking, while the pharmacy on the operation of the whole process of management have a detailed and true records, to ensure that the drug purchase channel is legitimate, the quality of the drugs are qualified, the management of the tracking in place, and effectively prevent the occurrence of various types of quality accidents. Quality accidents are effectively prevented. Since the opening of the pharmacy, there has been no distribution of counterfeit and shoddy drugs, no adverse reactions and customer complaints related to drug quality.
Six, the pharmacy in the purchase of drugs, storage, sales and after-sales service process, specifically to do the following
1, the purchase of drugs in strict accordance with the pharmacy's quality management system, to strengthen the quality assurance system of the supplier enterprises to audit, and require suppliers to provide the official seal of the "Drug License" and "business license" copy, the establishment of the supplier enterprise files to strengthen the supplier drug sales personnel qualification audit. Supplier drug sales staff qualification audit, and signed a quality assurance agreement with the supplier; the purchase of imported drugs require the supplier to provide the supplier to cover the original seal of the quality management body of the supplier unit "imported drug registration certificate" or "pharmaceutical product registration certificate", "imported drug inspection report" copy: from the source of the quality gateway.
2, the acceptance of drugs
The acceptance of the acceptance of the corresponding laws and regulations, the quality of the contract terms and quality standards, the appearance of the shape of the drugs, packaging and labeling strict acceptance, do not meet the requirements of the firm to be rejected.
3, standardize drug display management
pharmacy according to gsp requirements, standardize the drug display management, to do according to the use of classification, at the same time to do a good job of drugs and non-drugs, drugs and external drugs, easy to string of drugs stored separately, prescription drugs and non-prescription drugs in separate cabinets, as well as the demolition of drugs in special cabinets for storage, and the sign is obvious, clear. Monthly inspection of the display of drugs and truthful records.
4, pay attention to the maintenance of drugs
According to the quality management system of the pharmacy, the maintenance staff according to the storage conditions of the drugs for reasonable storage and display, daily morning and afternoon on time to record the temperature and humidity of the warehouse and the business premises, the temperature and humidity do not meet the requirements for the storage of medicines, and then take timely measures to regulate the temperature and humidity. At the same time, the quarterly inventory of general medicines for inspection, the key maintenance varieties of monthly inspection, key maintenance varieties also established maintenance files, maintenance records to achieve real, perfect, standardized.
5, do a good job in the sale of drugs
In order to standardize the behavior of the pharmaceutical industry, to provide consumers with assured that the drugs and quality service, prescription drugs dispensed by the prescription audit review, other drug sales staff can adhere to ask the disease, to do the "three questions", that is: ask the disease, ask the gender, ask the age of the "Three account", that is, account for service, account for dosage, account for precautions, according to the name of the customer purchased drugs, specifications, quantities, prices after checking the correct, award drugs handed over to ensure that the people's medication is safe and effective. At the same time, the pharmacy in the business hall express service conventions, publish supervision telephone and set up customer opinion book; and provide consulting services, guide customers to safe and rational use of drugs.
Part II GSP internal audit self-examination report
According to the "People's Republic of China *** and the State Drug Administration Law" and the new version of the "Drug Certification Practice" and the "Drug Certification Practice Implementation Rules," the pharmacy attaches great importance to the implementation of the GSP work, and carried out a serious preparation and a comprehensive inspection. Now the implementation of GSP certification of my pharmacy and self-inspection report is as follows:
First, the business profile
The store was established in November 21, 20xx store, located in Tianyuan Xincun 17 building 12 outlets, enterprise responsible for Wu Aizhi, the quality of the person in charge of Wu Aizhi. Scope of business: prescription and non-prescription drugs, proprietary Chinese medicines, chemical preparations, antibiotic preparations, biochemical drugs, Class B non-prescription drugs. Existing staff 4 people, including 1 pharmacist, has obtained the certificate of 3 people, business area of 106 square meters. The business area is 106 square meters and there are more than 800 kinds of products.
Second, quality management and system
Because of the small size of my store, fewer staff, less business, in view of such a situation is only the establishment of the quality management group, consisting of four with the composition of the pharmacy: respectively, the legal person: Wu Yan, quality management responsible for: Wu Aizhi (and pharmacist in the store), acceptance: Shen Yun Yun, caretaker: Li Fang. At the beginning of business, my pharmacy is in accordance with the GSP requirements to develop a set of quality management documents suitable for their actual situation of drug business, business process, my pharmacy in strict accordance with the GSP requirements to do. In the early days of business, some of the system implementation is not good, there has been the phenomenon of work is not standardized, after a few rectification now system has been fully implemented, has been fully in line with the new version of the "GSP" requirements.
Third, personnel and training
In order to continuously improve the professional and technical qualities of all staff, the development of learning and training programs, regular organization of all staff to learn the laws and regulations of drug management and professional and technical knowledge, every six months to conduct an assessment, and the establishment of training files.
Fourth, facilities and equipment
The enterprise in accordance with the new version of the GSP requirements are equipped with computers and meet the relevant management requirements of the drug purchase and sale of inventory management software, configured in the place of business to detect the temperature and humidity of the equipment, is now equipped with temperature and humidity meter, air conditioning. And equipped with rodent-proof, insect-proof, fire prevention equipment. The business place is clean, bright, business shelves, counters are available.
V. Drug purchase, acceptance management
According to the "Drug Administration Law" and "Drug Administration Quality Management Code" and other relevant laws and regulations, the purchase of drugs for quality and legal qualifications of the audit, and request for the official seal of the drug GSP certification, drug license (wholesale) and a copy of the business license, the letter of attorney should be clearly stipulated in the scope of the authorization and the authorized Term; copies of drug sales staff identity cards; purchase of imported drugs, to the supply unit for "imported drugs registration certificate", "imported drug inspection report" copy, and stamped with the original seal of the supplier's quality management organization; imported drugs should be marked in Chinese instructions. The first enterprise and the first drug to implement the audit system. Enterprises have established a drug purchase account, the account true and complete record of drug purchases, to achieve the ticket, account, things match, and then according to the relevant procedures to enter the computer to do the basic work.
Acceptance management: acceptance personnel on the purchase of drugs, according to the original documents and tax stamps, in strict accordance with the relevant provisions of the batch-by-batch inspection and acceptance and record. Mainly check whether the acceptance of the drugs in accordance with the corresponding appearance of quality standards. (1) Whether the outer package is firm and dry; whether the sealing label and seal are broken or not; whether the outer package indicates the generic name, specification, manufacturer, approval number, registered trademark, batch number and expiration date. For specific storage and transportation mark whether in line with the requirements of pharmaceutical packaging. (2) Whether there is a certificate of product conformity in each piece of inner packaging, whether the container is reasonable, whether there is any breakage, whether the sealing is qualified, the package should be clear handwriting, name, specification, batch number, etc. shall not be missing items; bottle labeling should be firmly affixed. (3) Drug labeling instructions are clearly printed with the generic name of the drug, ingredients, specifications, the name of the manufacturer, approval number, production lot number, production date, expiration date and so on. Labeling or instructions should also be indications or functions, dosage, contraindications, adverse reactions, precautions and storage conditions. (4) acceptance of imported drugs and their packaging labels in Chinese indicating the name, the main ingredients and registration number, with Chinese instructions, with "imported drug registration certificate", "imported medicinal materials batch" and "imported drug inspection report", and stamped with a copy of the supplier's quality management organization red seal. Timely collection of adverse drug reactions, the emergence of adverse reactions immediately reported to the drug regulatory authorities.
Six, drug storage, maintenance and display (retail) management
I enterprise in the beginning of the construction of the strict requirements of the GSP, the high standard of the storage and display environment, according to the municipal standards of decoration of the business area, so that the business premises spacious and bright. Convenient for shopping, conspicuous signs, according to the business situation and the requirements of GSP, the drugs are categorized. And according to the drug performance and nature of the partition, classification, the implementation of the color-coded management, the warehouse is divided into pending inspection area (yellow), the drug area (green), unqualified drugs area (red) and return area (yellow), so that the drugs and non-drugs, drugs for external use and internal use of drugs stored in separate areas, so as to facilitate the operation, to prevent errors, contamination of the incident occurred. Shelves, greenhouse meters, light-avoidance facilities (curtains), rodent-proof facilities (door seals) have been added to meet the requirements of the "seven defenses" (dust, insects, birds, rodents, moisture, mold, pollution). Lighting equipment that meets the lighting requirements has been installed. The business areas are equipped with air conditioners to ensure proper air humidity and temperature. In the work in accordance with the store's "drug storage, maintenance and display management system" for management, such as drugs and non-drugs are displayed separately, over-the-counter drugs are displayed separately from prescription drugs, drugs for internal use are displayed separately from drugs for external use, such as the "four separate principles" of categorization and display, including Special preparations containing ephedra preparations are displayed in special cabinets with warning slogans, and special cabinets in the zero-removal area are equipped with relevant zero-removal tools. In addition, every day in the afternoon and afternoon to measure the business area and the temperature and humidity of the warehouse, the emergence of non-compliance with the requirements of timely measures to regulate; monthly regular inventory and display of medicines for the maintenance of the inspection, and according to the requirements of the record, and so on.
Seven, sales and after-sales service
In order to provide consumers with assured drugs and quality service, the enterprise engaged in the retail sale of drugs, sales staff, business training and assessment. Sales of medicines, for customers to request the purchase of medicines, after checking the medicines handed over to the customer, and issue sales vouchers, while explaining in detail to the customer how to take the drugs and contraindications, etc.; in the place of business express service conventions, publish supervision telephone and set up a customer opinion book. The customer's evaluation and complaints to be resolved in a timely manner, the customer reflects the quality of drugs, seriously, detailed records, and timely processing.
VIII. Computer software system
The computer system is developed by a well-known domestic company: Shenzhen Wanguo SiXun Software Co. Relevant modules in line with the new version of the GSP application requirements, the daily inventory of automatic reminders, monthly inventory of near-expiry date products can be done to remind the sales call, the expiration of the enterprise and the expiration of the drug automatically limits the relevant procurement, acceptance and sales activities, the preparation containing marijuana can be automatically limited to the registration of the name and ID card sales, and so on.
IX, self-examination
I set up a self-examination group of pharmacy, led by the manager of Wu Yan, the quality of the person in charge of the implementation of the GSP management of self-examination and rectification of the situation:
First, the relevant files, records are scientifically summarized and sorted out; the second is to fill out the sales label specification of the shelves; the third is to the store hygiene and cleaning again; the fourth is to classify management of the situation Further inspection and standardization. Through the self-examination and self-correction activities GSP management level has been further improved.
Part III GSP internal audit self-examination report
I, quality management organizations and systems
With the gradual increase in the scale and scope of the company's operations, our company has continued to adjust and improve the company's quality system, enrich the quality management organizations and personnel, clarify the responsibilities of the various departments and personnel, the development of the enterprise quality management policy, objectives, the preparation of quality management procedures, and the development of a quality management program, and the development of the company's quality management policy, objectives, and the development of the company's quality management program. We have formulated quality management policy and objectives, compiled quality management program documents and operating procedures, implemented regular inspection and assessment to ensure that the company's quality management personnel to exercise their authority, more scientific and reasonable quality management organizations and personnel; according to the relevant provisions and requirements of the GSP, we have gradually revised and audited the quality management system, quality work procedures, organizations and job responsibilities, so that the company's quality management work to be evidence-based, rule-based, and improved the company's quality management system, and the company's quality management system. The company's quality management system has been improved and the quality management system and work procedures have been effectively implemented.
The enterprise set up an independent quality management department and full-time acceptance, maintenance group. The Quality Control Department has set up a quality management team and a quality acceptance team, which can carry out the relevant drug laws and regulations and the company's quality management documents. The Quality Control Department exercises quality management functions in all aspects of the enterprise's operation, and has the right to adjudicate the quality of drugs within the enterprise.
The company has developed a quality management system internal audit system, regular internal audit of the GSP operation to ensure the normal operation of the quality system.
Second, personnel training
In order to improve the overall quality of all employees, our company in addition to actively participate in the province, the city organized a variety of training, but also held a series of internal training. These include training in laws and regulations, the company's systems, work procedures, accountability training, skills training for various positions, drug classification knowledge training and staff moral education. All trainings are assessed and training files and assessment files are established to achieve more obvious training effects.
The leadership of the enterprise also attaches great importance to the national drug laws and regulations and drug management knowledge of learning, regular study and training organizations. The person in charge of the enterprise and the person in charge of quality are all undergraduates, the deputy general manager in charge of quality, quality control department manager and other quality management personnel are licensed pharmacists, and have a bachelor's degree or above, with rich practical experience and management ability. Engaged in quality acceptance, maintenance and sales personnel have a specialized education.
In accordance with the GSP requirements for all types of personnel, the company's direct contact with the drug practitioners to carry out health checks, qualified and licensed to work, and the establishment of health records, in the work of strict accordance with the relevant rules and regulations.
Third, facilities and equipment
My company's business and office space area of **** square meters, to meet the daily business and office requirements, the office environment is bright, clean, reasonably laid out, and equipped with the necessary modern office equipment, the sale of inventory computerized management.
Warehouse area of *** square meters, including cold storage *** square meters, cool storage *** square meters, Chinese herbal medicines and Chinese medicine tablets library *** square meters, medical equipment library *** square meters, to adapt to the requirements of the company's storage of drugs. Treasury to achieve a reasonable layout, the ground level, doors and windows tight, no source of pollution, with dust, moisture, mold, pollution, insects, rodents, birds, equipment, facilities, with fire safety facilities to meet the requirements. Waiting for inspection area, qualified products area, non-qualified products area, return area, shipping area to implement color-coded management, qualified products area and non-qualified products area and return area effectively separated, storage operation area, auxiliary operation area, office living area effectively separated. Each warehouse temperature and humidity monitoring and control equipment is complete, can adapt to the company's operation of the drug according to the physical and chemical properties and storage conditions of the library partition storage requirements.
Acceptance maintenance room **** square meters, equipped with one-thousandth of the balance, clarity detector, moisture meter, ultraviolet fluorescent lamps, standard colorimetric liquid, microscope, specimen room, zero cargo area, as well as drying oxygen, fumigation, maintenance and other special equipment, a variety of acceptance and maintenance of instrumentation and equipment have established the equipment file and the use of the file, maintenance.
Fourth, the purchase of goods management
The purchase of drugs management is the first level of quality control in the drug business, but also to ensure the legitimacy of business behavior, to ensure the quality of the drug business is a key link. Our company adheres to the principle of quality as a prerequisite and purchasing according to needs, and implements unified management of medicines, with purchasing organized by the purchasing department and sales by each business department. Purchasing department to develop monthly purchasing plan, purchasing plan development need to have quality control department related personnel to participate in, and reported to the supervisor for approval after the record.
Strictly control the quality of drug procurement, seriously implement the first enterprise, the first varieties of approval system and its procedures, drug purchase system and its procedures, pay attention to the quality assurance system of the supply unit investigation, to ensure that all supply units and the legitimacy of the purchase of drugs, and the supply unit of 100 percent signed a drug quality assurance agreement, the purchase of drugs vouchers are complete and true, and the establishment of a qualified supplier file.
V. Acceptance management
The Quality Control Department of our company is responsible for the quality acceptance of the purchased drugs and the sales of returned drugs, the Quality Control Department has set up a special acceptance team, the acceptance of the inspector strictly in accordance with the relevant systems and procedures for quality acceptance in the maintenance room.
Acceptance personnel in accordance with the statutory standards and procurement contracts on the purchase of drugs in accordance with the prescribed ratio of drug quality acceptance by batch, the first varieties, injections, a variety of dosage forms of the first purchase of drugs are the appearance of drug acceptance check, the unqualified drugs and counterfeit and shoddy drugs resolutely rejected to ensure that the certificate of acceptance of the drugs in the warehouse rate of 100 percent. Imported medicines have imported drug registration certificates and imported drug inspection reports stamped with the original seal of the supplier's quality management organization. The OTC drugs are accepted in accordance with the required labeling.
Drug acceptance record is the core basis for enterprise quality acceptance, where the acceptance of qualified drugs, must fill out the quality acceptance record in detail, the record content should be true and complete, do a good job of acceptance of the conclusions and signatures of the relevant personnel, acceptance records need to be preserved in accordance with the provisions of the record.
Sixth, storage and maintenance
In the storage of drugs, our company strictly in accordance with the requirements of the storage of drugs stored in separate libraries and classified storage, first of all, in accordance with the storage conditions required by the drugs were stored in the room temperature library, cool storage and refrigerated storage, and secondly, in accordance with the natural properties of the internal and external drugs will be separated from the storage of the drugs, easy to cascade the flavor of the drug, the non-medicine storage, will be close to the expiration date of the drug statement filled out monthly in accordance with the prescribed time. The company's website is a great place to find out more about the company's products and services.
Seriously do a good job of drug maintenance. In accordance with the provisions of the drug division of the stored drugs will be identified as key maintenance varieties, the development of key maintenance plan, the monthly cycle of maintenance, the establishment of drug maintenance records and maintenance files, strictly in accordance with the physical and chemical properties of the drugs and storage conditions for the storage and maintenance of the library, to ensure that in the library of the drugs of intact quality; every day to do a good job of temperature and humidity records, timely adjustment of temperature and humidity in the warehouse, and found that the problem reported in a timely manner.
For the company's sales of returned medicines, in accordance with the relevant operating procedures, the custodian of the sales department with the return vouchers issued by the receipt and storage in the return area, the acceptance of the acceptance of the qualified library into the qualified products, the acceptance of the unqualified storage of unqualified area, unqualified drugs are confirmed, reported, reported loss, destruction are in accordance with the provisions of the program, and the establishment of a comprehensive record file.
VII, warehousing and transportation
Drugs out of the warehouse is strictly implemented according to the principle of batch number shipment, the strict implementation of warehousing review system, review of drugs item by item, review found in the quality of the doubt immediately stop shipping, and reported to the Department of Quality Management to deal with, to ensure that unqualified drugs do not go out of the warehouse; according to the physical and chemical properties of the drug and transport conditions, equipped with thermal insulation, cold-proof, such as the necessary refrigeration and heat preservation equipment and transport safety facilities to ensure that during transportation, the transportation of unqualified drugs. Transportation safety facilities to ensure the quality of drugs in transit.
VIII. Sales and after-sales service
In order to strengthen the sales and service of medicines, the custodian and reviewer carefully review the quantity of medicines and check the quality of medicines. The sales department carries out sales activities in strict accordance with relevant laws and regulations and the quality management system of the enterprise to ensure that the drugs are sold to units with legal qualifications. Adhere to the law, do not have business relationships with units without qualifications for the operation and use of drugs, so that the sale of drugs are legal bills, the establishment of a complete sales record.
Ensure the quality of service, the implementation of the quality query system, good after-sales service. The company advocates enthusiastic service, and the establishment of customer complaints record file, tracking implementation. The company's regular customers and suppliers of drug quality inquiries, the quality of drug information in a timely manner to pass feedback, regular summary, the establishment of drug quality query records and quality information to pass feedback records. The occurrence of adverse drug reactions are tracked and monitored, reported in a timely manner, and drugs are recovered in a timely manner to ensure that the drugs are safe and effective.