Pharmacy self-inspection self-inspection report
Time in a hurry, a period of time has come to an end, look back at this period of time, there are a number of problems, take immediate action to write a self-inspection report. Then a detailed self-examination report to write how? The following is my carefully organized self-inspection of the pharmacy self-examination report, I hope to be able to help you.
Pharmacy self-inspection self-inspection report 1
According to the "Chinese People's Republic of China *** and the State Drug Administration Law" and the new version of the "Drug Certification Practice" and "Drug Certification Practice Implementing Rules", my pharmacy attaches great importance to the implementation of the GSP work, and carried out serious preparations and a comprehensive inspection, now I will be the implementation of the 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 the Tianyuan Xincun 17 building 12 outlets, the 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 same composition: respectively, the pharmacy legal person: Wu Yan, quality management responsible for: Wu Aizhi (and pharmacist in the store), the acceptance of the inspector: Shen Yunyun, 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 stages 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.
Three, personnel and training
In order to continuously improve the professional and technical qualities of all staff, the development of learning and training programs, and regularly organize all staff to learn drug management laws and regulations and professional and technical knowledge, every six months for an assessment, and the establishment of training files.
Four, facilities and equipment
The enterprise according to the new version of the GSP requirements are equipped with computers and in line with the relevant management requirements of the drug purchase and sale of inventory management software, in the business premises configured 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.
Fifth, the 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 obtain the official seal of the drug GSP certification, drug license (wholesale) and a copy of the business license. The power of attorney should specify the scope of authorization and authorization period; copies of drug sales personnel ID card; purchase of imported drugs, to the supply unit for "imported drug registration certificate", "imported drug inspection report" copy, and stamped with the original seal of the supply unit's quality management body; 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 line with the corresponding appearance of quality standards.
(1) Whether the outer packaging is firm and dry; whether the sealing label and seal are broken; whether the outer packaging indicates the generic name, specification, manufacturer, approval number, registered trademark, batch number and expiration date. For specific storage and transportation signs are in line with the drug packaging requirements.
(2) whether the inner packaging of each piece of product certification, whether the container is reasonable, whether there is no damage, sealing tightly whether qualified, the packaging should be clear handwriting, name, specifications, lot number, etc. shall not be missing; bottle sign should be firmly affixed.
(3) drug labeling instructions clearly printed with the generic name of the drug, ingredients, specifications, the name of the manufacturer, the approval number, the production batch number, production date, expiration date. 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 to indicate 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, a high standard of storage and display environment, according to the city council of the latest standard decoration of the business area, to achieve a spacious and bright business premises. Convenient shopping, eye-catching 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 protection facilities (curtains), anti-rodent 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, the temperature and humidity of the business area and the warehouse are measured every day in the morning and afternoon, and timely measures are taken to regulate the temperature and humidity when it is not in accordance with the requirements; the maintenance and inspection of the stock and the display of drugs are carried out on a regular basis every month and recorded according to the requirements, etc. These measures can ensure the storage quality of the drugs. These measures can ensure the quality of the storage of drugs
Seven, sales and after-sales service
In order to provide consumers with assured that the drugs and quality of service, the enterprise engaged in the retail of drugs sales staff, business training and assessment. The sales of drugs, for customers to request the purchase of drugs, after checking the drugs to the customer, and issued sales vouchers, while detailed to the customer to explain how to take the drugs and contraindications, etc.; in the business place to express the service convention, publish the supervision of telephone and set up the customer opinion book. The customer's evaluation and complaints are resolved in a timely manner, and the quality of drugs reflected by the customer is treated seriously, recorded in detail, and handled in a timely manner.
Eight, computer software systems
Computer system for the domestic well-known company: Shenzhen Wanguo SiXun Software Co. Relevant modules in line with the new version of the GSP application requirements, every day on the stock of automatic reminder, the monthly inventory of near-expiry products can be done to remind remind the sale of the expiry of the enterprise and the expiry of the drug automatically limit the relevant procurement acceptance of sales and other activities, on the preparation of preparations containing hemp can be automatically limited to the registration of the name and ID card sales, and so on.
Nine, self-examination
I set up a self-examination of the pharmacy team, 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 archives, records, scientifically summarized and collated;
The second is to standardize the sales of shelves labeling
The third is to re-clean the store hygiene;
The fourth is to further check and standardize the classification management.
Through the self-examination and self-correction activities GSP management level has been further improved.
Through the GSP self-inspection, we believe that we have initially met the standard requirements, is now applying for certification, welcome to the leaders to come to inspect and guide.
Pharmacy self-inspection self-inspection report 2
In order to further improve the management level of medical institutions, to ensure that the people use safe and effective drugs. In accordance with the "Regulations for the Implementation of the Drug Administration Law", "Drug Administration Quality Management Standard" and other relevant documents required to seriously carry out self-inspection, is now the relevant information reported as follows:
First, the basic situation
Second, the main implementation of the process and self-inspection
(a) Management responsibilities
Our hospital set up a leading group of pharmacy management, improve the system, clear the responsibilities of each person, the formulation of the pharmacy quality management policy, objectives, the implementation of the combination of regular inspections and routine inspections, so that the hospital pharmacy management to achieve evidence-based, rules and regulations to follow.
(2) Strengthen the education and training to improve the overall quality management quality of pharmacy practitioners.
1, in order to improve the overall quality of all staff, our hospital in addition to actively participate in the higher level of pharmaceutical administrative departments to organize a variety of training, but also adhere to the internal job training. These include training in laws and regulations, the hospital system, work procedures, accountability training, job skills training, drug classification knowledge training and practitioner moral education. All trainings are assessed and training files and assessment files are established to achieve more obvious training effects. The hospital regularly arranges medical checkups for practitioners who are in direct contact with medicines and establishes health records.
2, our hospital engaged in quality management, acceptance, maintenance, storage and sales of direct contact with the drug staff health checkups, insisting that all suffering from mental illness, infectious diseases or may contaminate the drugs of the staff are practiced first checkups before taking up their duties.
(C) Facilities and equipment
I strive to further increase the existing basis, in accordance with the relevant requirements, upgrade and remodel the pharmacy. Equip and replace dry hygrometers, drug shelves, refrigerated boxes. Improve the ventilation and thermostatic facilities of the pharmacy. The environment is bright, clean and well laid out.
(D) purchase management
1, strict purchase of drugs. Seriously implement the policy of the national basic drug system to ensure the legality of purchasing drugs 100%. Implementation of quality first, standardized business quality policy. With the supply unit 100% signed drug quality assurance agreement, drug purchase vouchers complete and true, strict quality control of drug procurement.
2, the acceptance of personnel in accordance with legal standards on the purchase of drugs in accordance with the prescribed proportion of drug quality inspection and acceptance of each batch, to ensure that the acceptance rate of storage drugs 100%, the unqualified drugs resolutely be rejected. The acceptance of the drugs allowed to be stored in the acceptance of each one of the registration.
(E) storage in the maintenance
1, conscientiously do a good job of drug maintenance. Strictly according to the physical and chemical properties of drugs and storage conditions for storage and maintenance in the library to ensure that the quality of drugs in the library intact.
2, every day to do a good job of temperature and humidity records, timely adjustment of temperature and humidity in the pharmacy, found that the problem is promptly reported.
(F) the management of special drugs: for special drugs in accordance with the provisions of the special person, special cabinet management. Strictly check the information after the issuance of drugs.
(VII) Dispatch of drugs and prescription
1, the pharmacy in strict accordance with the relevant laws and regulations and the hospital's 'quality management system to carry out sales activities, carefully checking the physician's prescription, the specifications of the drug, expiration date, method of consumption, precautions and patient names and other necessary information to ensure that the drugs are accurately paid.
2, to achieve the drug payment are in line with the relevant provisions. Keep the physician's prescription and establish a complete sales record.
3, to ensure the quality of service, the implementation of quality query system, good after-sales service.
4, the quality of drug information in a timely manner to pass feedback, regular summary, the establishment of drug quality query records and quality information transfer feedback records.
(H) the implementation of adverse drug reactions: the occurrence of adverse drug reactions tracking and monitoring, once the phenomenon of adverse drug reactions found to occur, timely report to the higher authorities, and timely recovery of medicines, and tracking services for patients. Ensure that the drugs are safe and effective and the patients' medication safety.
Third, there are problems
has been in the county drug department of the care and guidance, after all the staff of the *** with efforts to improve the quality management system, to strengthen their own construction, but there are still some problems:
1, to improve the conditions of storage of medicines and temperature regulating facilities, to meet the storage of medicine Temperature requirements;
2, the training of employees to be further strengthened;
3, the positions of quality management work self-consciousness and ability to be strengthened to do a better job of drug quality inquiries and drug adverse reaction investigations.
On the existence of the problem of our hospital will certainly be implemented one by one, and constantly check and rectify, so that the hospital's quality management of drug management more standardized and standardized.
Pharmacy self-inspection self-inspection report 3
In order to thoroughly implement the "Shandong Province, the use of drugs quality management standards", to improve the quality of medical care and the overall quality of the situation of our hospital pharmacy has been a serious, comprehensive check, self-inspection is as follows:
First, pharmacy staff to seriously study and implement the "Drug Administration Act" and the relevant medicinal laws and regulations, and strictly abide by the operating procedures, there are The quality management of drugs is the responsibility of a specialized person.
Second, a study plan has been formulated, and the operational staff regularly study legal knowledge and professional and technical knowledge to improve the overall quality of the operational staff and the level of business skills.
Third, the purchase of drugs strictly audit the supply unit, the purchase of drugs and sales staff qualifications, to ensure that the purchase of qualified drugs from legally qualified business enterprises.
Fourth, the late establishment of a complete purchase inspection and acceptance system. The main contents are: drug generic name, specifications, approval number, batch number, expiration date, manufacturer, supplier, purchase quantity, purchase date and so on. Acceptance inspection of drugs to do: accounts, tickets, things match. Acceptance records are kept for a specified period of time.
Fifth, the acceptance of the need to maintain special transportation conditions of the drugs, while checking whether the transport conditions meet the requirements, and make a record of the drugs do not meet the transport conditions will not be accepted.
Sixth, the pharmacy is neat and orderly, storage, display of drugs have special shelves and medicine cabinets, need to be refrigerated, light storage of drugs stored under the appropriate conditions. There are necessary dust, moisture, fire, anti-theft, anti-pollution, anti-rodent facilities, regular maintenance of all facilities and equipment, maintenance instruments, timely repair.
VII. Regularly check the quality of stored and displayed drugs, and observe the indoor temperature and humidity every day. The display of drugs according to the dosage form is arranged separately. Drugs and non-drugs, internal and external drugs are placed separately.
VIII, the dispensing room is clean, the drugs and the items used to be placed in a fixed position, the staff in strict accordance with the operating procedures of the dispensing room, the dispensing to do the "four checks and ten pairs" unqualified prescriptions refused to issue drugs, the issue of drugs carefully check to prevent errors and accidents.
IX, drugs according to the "first produced first, near the expiration date first out" and the principle of issuing drugs by lot number. Within six months of the expiration date of the drug fill in the expiration date of the drug register, fill in the loss of the drug report, timely destruction.
X. Adverse drug reaction reporting system, a person responsible for the collection and reporting of adverse drug reaction information. Adverse drug reactions found in a timely manner to fill out the "Adverse Drug Reaction/Event Reporting Form" to the higher authorities to report.
XI, a monthly inventory, the account is consistent.
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