Part I Special Drugs Self-inspection Report
According to the "Drug Administration Law" and its implementing regulations and the "Drug Administration Quality Management Standard" requirements, in order to make the XXX Pharmacy as early as possible to pass the GSP certification, in the xx food and drug supervision departments under the guidance of the pharmacy in strict accordance with the "Drug Retailer GSP on-site inspection guiding principles" to carry out self-inspection. Inspection Guiding Principles" for self-inspection, is now reported as follows:
First, the basic situation
XXX Pharmacy belongs to a single-unit pharmacy, no pollution sources around the business address, no high-risk facilities, the business premises are spacious and bright, clean and hygienic, the layout is reasonable. The approved business scope of the pharmacy is: traditional Chinese medicine tablets, proprietary Chinese medicines, chemical preparations, antibiotic preparations, biochemical drugs. According to the GSP requirements, our pharmacy has improved the corresponding equipments, revised the duties of each position and related regulations, and carried out GSP transformation from both hardware and software, which has received better results. The pharmacy adheres to the law, honest and trustworthy, in the GSP certification and daily operation without any deceptive behavior.
Second, the implementation of GSP self-examination of enterprises
(a) quality management and responsibilities
My pharmacy in accordance with the relevant laws and regulations and the "Code of Practice for the Quality Management of Pharmaceutical Business," the requirements of the formulation of quality management documents to carry out quality management activities, to ensure the quality of drugs. We have established operating conditions that are appropriate to the scope and scale of our pharmacy's operations, including organization, personnel, facilities and equipment, quality management documents, and set up a computer system in accordance with the regulations.
XXX is the main person responsible for the quality of drugs, responsible for the daily management of the pharmacy, to ensure that the quality management personnel to effectively fulfill their duties, and supervise the position of personnel to implement the laws and regulations of drug management and the "norms" requirements. Equipped with a quality administrator XXX is specifically responsible for the quality of drugs, the development of quality management documents. The quality administrator is responsible for auditing the qualifications of the supplying units and their salespersons, auditing the legality of the purchased drugs, guiding and supervising the quality management of the drug purchasing, storing, displaying, selling and other aspects of the work, doing a good job of the drug quality query and quality information management work, confirming and dealing with the unqualified drugs, being responsible for the report of the adverse reaction of the fake and shoddy drugs, and doing a good job of the quality of the drug quality management education and training, computer system operation. Management education and training, computer system operation authority review, control and quality management of basic data maintenance and calibration and verification of measuring instruments, guidance and supervision of pharmacy services. Responsible for other duties that should be performed by the quality manager.
(B) personnel management
I pharmacy personnel engaged in drug business and quality management work, in line with relevant laws and regulations and the "norms" requirements, no industry ban. The person in charge of the enterprise XXX has the qualification of XXX pharmacist, guiding the rational use of drugs. The quality administrator is XXX with the technical title of XXX pharmacist. The salesman XXX has XX education, and the dispenser of traditional Chinese medicine tablets XXX has XXX education (delete this sentence if there is no traditional Chinese medicine tablets).
XXX and XXX have received pre-service and continuing education training on relevant laws and regulations as well as pharmaceutical professional knowledge and skills. The enterprise has formulated an annual training program and carried out training. Annual health checkups are conducted every year, and all of them have obtained health certificates and established health records to meet the requirements for employment. My pharmacy does not store items unrelated to business activities and personal items and behaviors that affect the quality and safety of drugs.
(C) Documents
Our pharmacy has formulated practical quality management documents in accordance with relevant laws and regulations, including quality management system, job responsibilities, operating procedures, files, records and vouchers. And it is regularly reviewed and revised in time. Through training, the personnel in each position are made to understand the contents of the quality management documents correctly to ensure the effective implementation of the quality management documents. And we have formulated the quality management system of drugs: the management system of drug purchase, acceptance, display, sales, storage and maintenance, the audit system of supply units and purchasing varieties, the management system of sales of prescription drugs. Drug splitting management system, special management of drugs and the state has special management requirements of the drug management system, records and vouchers management system, the collection and query quality information management, quality accidents, quality complaints management system, Chinese herbal medicine prescription audit, dispensing, verification management system, drug expiration date management system, unqualified drugs, drug destruction management; environmental hygiene, personnel health system, medication counseling, The company has set up the management system of pharmacy services, such as guiding the rational use of medicines, personnel training and assessment system, adverse drug reaction reporting system, computer system management system, implementation of the system of electronic monitoring of medicines, and formulated the duties of the person in charge of the enterprise, quality management, purchasing, acceptance and inspection, salespersons, as well as the positions of prescription auditing and dispensing, and so on. Established a dozen operating procedures for drug purchasing, acceptance, sales, prescription review, deployment, checking and so on.
The establishment of drug procurement, acceptance, sales, display inspection, temperature and humidity monitoring, unqualified drug treatment and other related records, to achieve true, complete, accurate, effective and traceable. Records and related vouchers should be kept for at least 5 years.
Record data through the computer system, the relevant positions should be in accordance with operating procedures, through the authorization and password to log on to the computer system, data entry, to ensure that the data is original, true, accurate, safe and traceable.
(D) facilities and equipment
The enterprise's business premises and its pharmaceutical business scope, business scale is appropriate. Enterprise business area of XX square meters, clean environment, reasonable layout, well ventilated, no pollutants, business premises, living quarters separate. There are XX sets of shelves for business use, XX sets of counters, and sales cabinets are clearly marked. Due to the legal and reliable drug supply channels, the sold drugs can be replenished in time, and after acceptance, they are put on the shelves and cabinets in time, so the store does not have a warehouse. The medicine shelves and cabinets are able to keep more than 10cm between the medicines and the ground. The pharmacy is equipped with equipment to prevent dust, moisture, insects and rodents. 1 temperature and humidity meter, 1 dehumidification appliance, 1 ventilation fan, 1 piece of sticky rodent board, equipped with blending tools and packaging supplies required for the split-sale of medicines in compliance with the requirements. And there is a special cabinet containing *.
(E) procurement and acceptance of drugs
1, drug procurement
Drug procurement management is to ensure the quality of the key links in the drug business. Effective supervision and control of the drug procurement process, in order to strengthen the management of drug procurement, we first developed a strict procurement management system in the procurement process, the specific matters of the procurement process, the first enterprise and the purchase and sale contract for effective control and regulation.
(1) Purchasing enterprise legitimacy
Qualified suppliers, the first enterprise to assess the legitimacy of the purchaser is responsible for obtaining relevant information from the supplier, such as the original seal of the enterprise production or business license, business license and its copy of the annual inspection certificate, the "Good Manufacturing Practices for Drug Manufacturing" certification or "Good Management Practices for Drug Operation" certification certificate. Copies of the relevant seals, with the goods with the single (ticket) style, account name, account bank and account number, "Tax Registration Certificate" and "Organization Code Certificate" copy, through the investigation and understanding of the first enterprise to fill in the approval form, qualified by the quality administrator, there are pharmacies in charge of the approval of the consent to the establishment of a qualified supplier file.
(2) the legitimacy of the purchase of drugs
The purchasing agent to purchase drugs, should be to the supply unit to obtain an invoice. The invoice should set out the generic name of the drug, specifications, units, quantity, unit price, amount, etc.; procurement of drugs should be established procurement records. Purchasing records should have the generic name of drugs, dosage forms, specifications, manufacturers, supply units, quantity, price, purchase date and so on.
(3) the legitimacy of the supplier salesman and the signing of the quality assurance agreement
Check the supplier salesman's business behavior and its business "certificate, license" approved by the mode of operation, the scope of business is consistent. Ask the supplier salesman to supply the original seal of the sales staff ID card copies; check the original seal of the supplier and the legal representative of the seal or signature of the authorization, the authorization should contain the name of the authorized person, ID number, and authorized the sale of varieties, geographic areas, the period of time; the supply unit and the supply of varieties of relevant information.
The signing of the quality assurance agreement should clarify the quality of the two parties responsible; the supply unit should provide information in line with the provisions of the authenticity and validity of the responsibility; the supply unit should be in accordance with the national provisions of the invoices; drug packaging, labeling, instructions in line with the relevant provisions of the quality assurance and responsibility for the transportation of medicines; the validity of the quality assurance agreement period.
The quality manager is responsible for the verification of the above work audit, audit qualified materials and quality assurance agreement together with the qualified supplier file.
2, the acceptance of drugs
In order to ensure the quality of purchased drugs, to prevent the entry of counterfeit and inferior drugs into the store, we have formulated the management of the acceptance of drugs.
When the drugs arrive, the acceptance personnel should be in accordance with the procurement records, against the supply unit of the accompanying counterparts to verify the drugs in kind, so that the ticket account goods match.
Enterprises in accordance with the established procedures and requirements for the arrival of drugs batch by batch acceptance, acceptance of the samples taken should be representative. Acceptance inspection personnel should be sampling the appearance of drugs, packaging, labeling, instructions and related documents, etc., one by one check, check.
The acceptance officer according to the quality of acceptance of the actual situation, the acceptance of the quality of the drug record at the same time to make acceptance of the conclusion, and to retain the acceptance record. Rejection of unqualified drugs, and reported to the quality manager.
(F) display and storage
The store of the drugs operated in strict accordance with the requirements of the "Code of Practice for the Quality Management of Pharmaceutical Business", to achieve the principle of the four separation, that is, drugs and non-drugs, drugs for internal and external use are stored separately, prescription drugs are placed in separate cabinets with over-the-counter medicines, drugs that are easy to cascade the flavor of the drugs are stored separately from the general drugs and stored in accordance with the characteristics of the drugs, and the zero-zero drugs are concentrated in the zero-zero special cabinet, retaining the original packaging. The drugs are stored according to their characteristics, and the drugs are centrally stored in the special cabinet for the removal of parts, and the original package labels and instructions are retained.
The quality and packaging of medicines on display are in accordance with the regulations, and the quality of medicines on display is inspected and recorded every month, and medicines found to be problematic are immediately withdrawn from the shelves and counters, and the relevant records are filled in. The place where the drugs are displayed and the shelves and counters are kept clean and hygienic. There are fire, moisture, insect, rodent, light facilities and equipment.
In order to ensure the quality of drug storage, the drug care staff of the display of drugs on a regular monthly inspection, perishable, near-expiry date, easy to moisture the drug weekly quality checks, found that the problem in a timely manner to take effective measures to deal with the problem. At the same time to do a good job of maintenance inspection records, regularly summarize, analyze and report the quality of drug maintenance information.
Part II Special Drugs Self-Inspection Report
In order to carry out the spirit of the relevant documents issued by the Xx County Board of Education, and to further strengthen the use of hazardous chemicals in the school, management, to protect the school and teachers and students of the safety of life and property, our school recently on the safety of the use of chemicals, the management of a thorough inspection, is now checking the situation reported as follows:
First, the use of chemicals in the school is not only the use of chemicals, but also the use of chemicals. The situation is reported as follows:
First, the organization is sound in order to strengthen the use of hazardous chemicals in schools, management of supervision and inspection work, the members of the inspection team are required to use a combination of regular inspections and unscheduled spot checks, to strengthen the inspection of the safe management of chemicals, found that the problem, correct and rectify in a timely manner.
Second, the establishment of a comprehensive system of instrumentation room, laboratory a variety of systems are complete, are on the wall publicity. Specifically, there are "hazardous chemicals management system", "the use of hazardous chemicals system", "laboratory managers", "instrument room managers", "the use of chemicals registration system", "chemical experiments, emergency response" and so on.
Third, a clear task, the responsibility of the school in order to strengthen the management of chemicals, the implementation of accountability, whoever is in charge of who is responsible for the problem, an investigation to the end. Science instrument room, science laboratory by the office in charge, the inspection team to supervise.
Fourth, the management and use of dangerous, highly toxic drugs:
1, the school should establish a dangerous, highly toxic drugs account, from the purchase, warehousing, receipt, use, disposal must be timely, accurate records, to achieve the account, the account is consistent.
2, the school should be dangerous goods (the establishment of a special cabinet). Laboratory managers should make regular checks of dangerous goods.
3, laboratory managers should be dangerous categorized storage, keep a safe distance from each other, forbidden to mix; strong acid, strong alkali should be locked custody, placed in the 'place' not easily accessible to outsiders. Strictly keep all kinds of chemical hazards and highly toxic products, so that people away from the door lock.
4. When teachers use dangerous and poisonous drugs, they must fill in the "Dangerous and Poisonous Drugs Usage Sheet" and get approval before they can collect the required quantity from the administrator. If there is any surplus of hazardous and highly toxic drugs after use, the teacher shall return them to the laboratory and indicate the quantity of drugs returned on the original requisition form. Teachers and laboratory personnel who use dangerous chemicals must comply with the operating procedures and strictly implement safety measures.
5, chemical hazardous, highly toxic drugs once found lost, stolen, should be immediately reported to the school leadership, the education department and the local public security departments.
5, the disposal of waste dangerous and highly toxic drugs after the test of dangerous and highly toxic drugs, such as waste liquid or residue should be stored centrally, by the school teacher regular safety treatment or destruction. Minimize the pollution of the environment in the treatment process.
Six, check the situation:
1, chemicals can be stored in accordance with the requirements for safekeeping.
2, flammables, explosives have a special cabinet storage and lock.
3, hazardous chemicals have a special cabinet, cabinet lock.
Part III Special Drugs Self-inspection Report
According to the Guangdong Provincial Drug Administration Quality Management Standard (GSP) certification management approach (for trial implementation) and the "Drug Administration Quality Management Standard On-site Inspection Guiding Principles," the provisions of the company's self-inspection on the implementation of the GSP report is as follows:
First, the company's basic situation.
Our company was founded in XXXX on XX/XX/XXXX, the company's registered capital of XXXXX million yuan, the business scope of: XXX, XXXX, XXXX, XXXX. our existing staff of XX people, including XX practicing pharmacists, pharmacy technicians XX people (including practicing pharmacists), pharmacy technicians accounted for the total number of employees of the XXX% of the company set up the quality control department, the business department, Storage and Transportation Department, Finance Department, Administration Department, Information Management Department *** six departments, the company's sales last year XXXX million yuan, our company operates XXXX varieties, operating XX varieties XX. The company to "XXXXX" for the quality policy, in accordance with the law and regulations engaged in pharmaceutical business activities, strict quality control, to prevent the entry of fake and shoddy drugs into the company, opened so far has never occurred in the operation of fake and shoddy drugs behavior.
Second, the operation of the quality system
1, the quality system documents
The company compiled the "quality management system" XX, "quality management procedures" XX, "departmental and post quality responsibilities at all levels" XX and other documents, composed of the company's quality system of standardized documents, is the company to carry out the quality of management work of the textual basis for the quality management, the Department of quality control to carry out the necessary ``documentation'' on the documents. The quality control department has carried out the necessary `training on the documents.
2, the staffing situation
(1) the company's legal representative, the person in charge of the enterprise XXX general manager is XXXX education, XX title, familiar with the national laws, rules and regulations relating to drug management, regulations and knowledge of the drugs operated.
(2) the quality of the person in charge of XXX for the licensed pharmacist, qualification certificate No.: XXXXXXXX, XX bachelor's degree, engaged in the quality of drug management for more than XX years, familiar with the national laws, regulations, rules and regulations relating to drug management and knowledge of the drugs operated by the company, able to independently solve the quality of the operating process of the quality of the problem, the quality of the management of the work of the ability to carry out the right to judge and guarantee the implementation of the implementation of the quality of the work.
(3) The person in charge of the quality management organization, XXX, is a professional pharmacist, with the qualification certificate No. XXXXXXX, specializing in XXXX, who is able to adhere to the principle, has rich practical experience, and is able to independently solve the quality problems in the process of operation.
(4) Warehouse quality control officer XXX, XXXXX graduated, quality control officers are professional and job training, can independently solve quality problems found in the quality management process.
(5) Warehouse Receiving and Inspection Clerk XXX, XXXX professional bachelor's degree, Chinese pharmacist; Warehouse Receiving and Inspection Clerk XXX, XXXXX graduated from the Western Pharmacist. Receiving inspectors have been trained in professional positions, and can independently solve the quality problems found in the inspection process.
(6) Warehouse caretaker XXX, XXXX education; warehouse caretaker XXX, XXXXX education. Conservators have been through professional and job training.
(7) Purchaser XXX, XXXX education, Chinese pharmacist; salesman XXX, XXX education, XXX, XXX education. Purchasers and salespersons have been trained in their specialties and positions.
(8) engaged in quality management, acceptance, maintenance, storage and other direct contact with the position of drug personnel, our company has organized annual health checks, and the establishment of employee health records.
Third, the office and warehouse
Our business office area of XXX square meters, equipped with computers, telephones, fax machines, printers, photocopies, and other modern business office equipment, spacious and bright working environment. The total area of the warehouse is XXX square meters: the area of cool storage is XXX square meters, the area of room temperature storage is XXX square meters, and the cold storage is XX cubic meters. Inside the warehouse, the walls and roof are clean, the ground is flat, and the doors and windows are tightly structured. The warehouse is covered with matting to effectively isolate the drugs from the ground; it is equipped with heat-insulating boards, exhaust fans, mosquito lamps, rat cages and other equipment for avoiding light, ventilating, preventing moisture, insects and rats; it is equipped with XX air-conditioners, which can effectively regulate the temperature and humidity as well as indoor/outdoor air exchanges; and it is installed with XX automatic temperature and humidity monitoring terminals (including XX detection terminals of refrigerated transport trucks), which can monitor and record the temperature and humidity and the transportation of refrigerated drugs in the warehouse automatically. It can automatically monitor and record the temperature and humidity of the warehouse and the temperature and humidity of the transportation process of refrigerated drugs. Configure one cold storage of XX cubic meters, equipped with double refrigeration units and standby generator sets; and purchase one refrigerated truck, XX liters of refrigerated boxes XX, and in XXXX XX month of XXXX on the cold storage, refrigerated boxes, and refrigerated trucks to verify that the configuration of refrigerated trucks is in line with the requirements of the relevant national standards, and can ensure the requirements of the transportation of refrigerated and frozen medicines. Cold storage, refrigerated trucks and insulation boxes are equipped with automatic temperature and humidity detection system, which can collect, display and record the temperature and humidity data in real time, and have the function of remote and local real-time alarm, and the recorded detection data can be read and stored by computer. The warehouse is divided into qualified products area, delivery area, pending inspection area, return area, non-conforming products area, out of the warehouse review to go, zero cargo area and other special places, and according to GSP requirements for the implementation of color-coded management.
Fourth, the management of computer systems
The company has installed "XXXX" computer system terminals **** XX, in line with the operation of the whole process and quality control requirements, to achieve the quality of drugs can be traced, and to meet the implementation of electronic monitoring of drugs conditions. The company's computer system has servers that support the normal operation of the system; it has a safe and stable network environment that can realize information transmission and data **** enjoyment between departments and posts, and establish relevant databases. The company's see accounting system is able to make true, complete and accurate records and management of the purchase, acceptance, maintenance, outbound review and sales of medicines, as well as generating and printing the relevant medicine business bills. The company requires all positions to carry out computer system data entry, modification, preservation and other operations according to the scope of authorization to ensure that the data is original, true, accurate, safe and traceable, the computer system operation involves business operations and management of the data back up on a daily basis and stored in a safe place, the relevant records in accordance with the provisions of the preservation of the 5 years.
V. Self-inspection against the standard
XXXX XX month XX - XX day of XXXX our company based on the "Drug Quality Management Code" (Ministry of Health Order No. 90) and its appendices, "XX Province, the pharmaceutical wholesale enterprises GSP certification on-site inspection of the project list" of the company's quality management system for an internal review, the results of the review: XX serious defects in the project, the general The results of the evaluation were: XX items of serious defects, XX items of general defects, basically in line with the requirements of the conditions set out in the GSP, and is now applying to your bureau for GSP certification.
Part IV Special Drugs Self-Inspection Report
In order to further improve the management level of medical institutions, to ensure that people use safe and effective drugs. According to the County Health Bureau and the County Food and Drug Administration jointly issued a relevant document requirements, in order to do a good job in the standardization of drug management, we in accordance with the "Regulations for the Implementation of the Drug Administration Law", "Drug Business Quality Management Code" and other relevant documents required to seriously carry out a self-inspection, is now reported on the relevant information as follows:
First, the basic situation
Our hospital is located in Fengjie County Longqiao Township, is a public non-profit The hospital is a public non-profit medical institution that undertakes disease prevention and control, health education and basic medical services for the township's population of more than 10,000 people. The scope of drug use is implemented in strict accordance with relevant regulations and systems. Since its establishment, our hospital has been adhering to the service concept of putting patients first. Adhering to the principle of running the hospital in good faith, operating in accordance with the law, high quality and good price, there is no illegal behavior in drug business, and no quality accidents occurred in the drugs operated. Pharmacy management 2 people, mainly engaged in drug quality management, acceptance and daily maintenance work. The pharmacy covers an area of 20 square meters. It has set up a drug management team headed by the president, has formulated more than 10 regulations and management systems, and has actively taken effective measures to continuously strengthen learning and training to improve the comprehensive quality of the pharmacy management personnel. Adhere to the operation of the law, strengthen internal management, the establishment of a long-term mechanism for drug management, to ensure the quality of drugs, to ensure that the people's medication is safe and effective to make a positive contribution.
Second, the main implementation process and self-examination
(a) management responsibilities
1, our hospital set up a "leading group of drug quality management work", clear responsibilities of all personnel, the development of the pharmacy quality management policy, objectives, the preparation of quality management program documents and operating procedures, the implementation of The regular inspection and routine inspection combination, so that the quality of management of the hospital's pharmaceuticals to achieve evidence-based, rules and regulations to follow.
2, our hospital medicines adhere to the implementation of full-time acceptance, special care. The establishment of a full-time quality manager and quality inspector, the use of drugs in the outpatient pharmacy and drug turnover library of the warehouse are able to carry out the relevant drug laws and regulations and the hospital quality management documents.
3, the hospital has developed a quality management system internal audit system, regular internal audits of the operation of the norms to ensure the normal operation of the quality system.
(B) Strengthen education and training to improve the overall quality management quality of pharmaceutical 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's systems, 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
1, the hospital strives on the basis of the existing, and further increase efforts, in accordance with the relevant requirements, upgrading and remodeling of the pharmacy. Equipped with and replaced with dry hygrometer, drug shelves, refrigerated boxes. Improve the pharmacy ventilation and thermostat facilities. The environment is bright, clean and well laid out.
2, on the basis of the existing pharmacy upgrading and remodeling, can adapt to the requirements of the hospital's storage of drugs. 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 in line with the requirements.
(D) purchase management
1, the strict purchase of drugs. Seriously implement the national drug procurement policy to ensure that 100% of the legitimacy of the purchase of drugs. Implement the quality policy of "quality first, standardized management" and strictly control the quality of drug procurement.
2, the acceptance of personnel in accordance with legal standards for the purchase of drugs in accordance with the prescribed ratio of drug quality inspection and acceptance of each batch, to ensure that the acceptance rate of storage drugs 100%, unqualified drugs resolutely be rejected. Acceptance of the acceptance of drugs allowed to be stored one by one for 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 warehouse, found that the problem is reported in a timely manner.
(F) the management of special drugs
The use of 'special drugs to implement 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 check the physician's prescription, the specifications of the drug, the expiration date, the method of taking, precautions and the patient's name, 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 to track and monitor, once the phenomenon of adverse drug reactions found to occur, timely reporting to the national adverse drug reaction monitoring network, and timely recovery of medicines, and tracking services for patients. Ensure that the drugs are safe and effective and the patients' medication safety.
Third, the self-examination summary and solutions to existing problems
Has been in the county drug department under the care and guidance, after all the staff of the *** with efforts to improve the quality management system, to strengthen their own construction. After self-examination that: basically meet the conditions set by the drug authorities.
1, with a legal and effective "medical institutions license".
2, no illegal operation of fake and shoddy drugs.
3. Improvement of drug storage conditions and temperature regulation facilities to meet the temperature requirements for drug storage.
4, at the same time, we found some problems and deficiencies will take effective measures to seriously rectify. The main performance: First, the training of staff to be further strengthened; Second, the positions of quality management work on self-examination and the ability to be strengthened; Third, the strength of the service work needs to be strengthened to further improve the quality of drug quality inquiries and adverse drug reaction investigation.
Our hospital will definitely implement one by one according to the problems found in the process of self-inspection and internal audit, and constantly check and rectify to make the quality management of drug operation in our hospital more standardized and standardized.
Part V Special Drugs Self-Inspection Report
In compliance with the State Food and Drug Administration on the implementation of the announcement of the quality management standard for the operation of medical devices (No. 58 of 201x) the spirit of the document, the organization of the relevant personnel focused on my company's operation of all medical devices to carry out a comprehensive inspection, is now the specific situation reported as follows. The specific situation is reported as follows:
First, strengthen the system management, improve the quality management system, to ensure the quality and safety of the products in the operation process
The company set up a general manager as the main leadership core, the department managers as the main members of the organization, all employees as the main supervision and implementation of the members of the safety management organization, the safety of medical devices into the management of the work of my company's top priority. Strengthen the leadership, strengthen the responsibility, enhance the awareness of quality responsibility.
The company has established and improved a series of medical device related management system: medical device procurement, acceptance, storage, sales, transportation, after-sales service and other aspects of the effective quality control measures to ensure that the company's business activities to ensure the safe and smooth.
Second, clear job responsibilities, strict management system, improve and save the relevant records or file management system
The company from the general manager to the quality of the person in charge of the various departments of the staff of each link in strict accordance with the quality management standard for the operation of medical equipment management system to develop appropriate management system, the purchase of medical devices have the conditions and the qualifications of the supplier to make a rigorous provisions to ensure that the quality of medical equipment purchased and the use of medical equipment, and to ensure that the quality and use of the company. To ensure the quality and safety of purchased medical devices, and to prevent unqualified medical devices from entering the hospital. To ensure the legitimacy and quality of incoming medical devices, the company carefully implements the in/out system to ensure the safe use of medical devices.
The enterprise quality officer is responsible for the quality management of medical devices, with independent decision-making power, mainly organizing the development of quality management system, guidance, supervision of the implementation of the system, and the implementation of the quality management system to check, correct and continuous improvement, timely collection of laws and regulations related to the operation of medical devices and related regulations, and the implementation of dynamic management. For the confirmation of unqualified medical devices, the collection and reporting of adverse events as well as quality complaints and device recall information and other events real-time supervision, regularly organize or assist in quality management training. The company has been in accordance with the requirements of the new version of the quality management standard for the operation of devices on all computer systems for the transformation and upgrading, the installation of the latest version of the new space-time software system to meet the whole process of the management of medical devices and quality control, and the establishment of the relevant records and archives, for the previous part of the qualification of the supplier to stay in the file is not perfect, but also timely to ask for supplementation to make further improvements to the preservation of the situation.
Third, personnel management
Our company medical equipment work by professional and technical personnel, and regularly carry out the relevant laws and regulations and related systems of training to ensure the smooth progress of the work; annual organization of direct contact with the medical equipment staff health checks, and build a health file.
Fourth, warehouse management
The company has hardware facilities and equipment to meet the requirements of the medical device warehousing, acceptance and storage and transportation requirements, independent storage of medical devices, categorized storage, separate storage of instruments and non-instrumentation, and the establishment of the latest warehousing management system and the medical device maintenance system, to strengthen the quality of the storage of the instrumentation management, there are personnel to do a good job in the day-to-day maintenance of the instrumentation. To prevent unqualified medical devices from entering the market, and develop an adverse incident reporting system.
Our company has always adhered to the "quality first, customer first" quality policy, in strict accordance with the "Code for the Quality Management of Medical Devices" requirements, to increase the warehouse medical device safety program inspection, timely investigation of medical devices hidden danger, regular self-checks, to ensure that the effective implementation of various systems.