Self-inspection report on drugs and devices (General 6)
In the blink of an eye a period of time comes to an end, looking back on this period of time, there are problems that are very worth summarizing, and it is very important to write a self-inspection report at this time. Are you still struggling to write a self-examination report? The following is my compilation of self-examination report on drugs and devices (General 6), welcome to learn and reference, I hope to help you.
Self-inspection report on drugs and devices 1
My company in accordance 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 20xx) the spirit of the document, the organization of the relevant personnel focused on my company's operation of all the medical devices to carry out a comprehensive inspection, the specific circumstances are reported as follows:
First, strengthen the system management, improve the quality management system, to protect the quality and safety of products in the business process
The company set up a general manager as the main leadership core, the department managers as the main organization members, all employees as the main supervision and implementation of the members of the safety management organization, the management of medical equipment safety into my company's work is the most important thing. 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 safety of the smooth running of the system.
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 are strictly in accordance with the quality management standard for the operation of medical equipment management system to develop the corresponding management system, the purchase of medical equipment and the conditions of the supplier with strict provisions of the qualification. The company has made strict regulations on the conditions for the purchase of medical devices and the qualifications of suppliers to ensure the quality of purchased medical devices and the safety of their use, 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 quality manager of the enterprise is responsible for the quality management of medical devices, with independent decision-making power, mainly organizing the development of quality management system, guiding and supervising the implementation of the system, and checking, correcting and continuous improvement of the implementation of the quality management system, and timely collection of laws, regulations and other relevant provisions related to the operation of medical devices 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 device business quality management standards for 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 management and quality control of medical devices, and the establishment of the relevant records and archives, for the previous part of the supplier qualifications in the archives is not perfect, but also a timely request for supplementation to make further improvements to the preservation of the situation.
Three, personnel management
Our medical equipment work by professional and technical staff, and regularly carry out the relevant laws and regulations and related systems of training, to ensure the smooth progress of the work; the organization of direct contact with the medical equipment every year, staff health checks, and build health records.
Fourth, warehouse management
The company has hardware facilities and equipment to meet the requirements of warehousing, acceptance and storage and transportation of medical devices, independent storage of medical devices, categorized storage, separate storage of instruments and non-instrumentation, and the establishment of the latest warehousing management system and medical device maintenance system, to strengthen the quality of the stored equipment management, with a dedicated staff to do the daily routine of instruments. Specialized personnel to do the daily maintenance of equipment. To prevent unqualified medical devices from entering the market, and to 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 the effective implementation of the system.
Drugs and Devices Self-Inspection Report 2To implement the flag Food and Drug Administration of our hospital drugs, medical equipment quality inspection, to protect the people to use medical devices safe and effective, standardize the use and management of drugs. The hospital set up a self-examination team headed by the president, in accordance with the Xiwuqi Health Bureau issued "on the effective strengthening of medical institutions at all levels of drugs, medical equipment safety management notice" and "Drug Administration Law", "Drug Use Quality Management Standard", "standardize the standards of the pharmacy" one by one self-check, one by one, self-checking the team did a lot of detailed self-checking, self-checking the report is as follows:
Agency, personnel, and medical equipment, and the quality of the people's medical equipment. strong> A, institutions, personnel and systems:
Our hospital has a "medical institutions practice license" and other legal qualifications. The establishment of a drug quality management organization, composed of the director in charge, the head of the Pharmaceutical and Device Section, the head of the pharmacy, the quality of the person in charge, the purchaser, to clarify the responsibilities of all levels of personnel and institutions. At the same time, various quality management rules and regulations have been formulated as a safeguard and carefully organized and implemented. At the same time, we have established and improved our hospital's pharmacy management committee, clinical rational use of antimicrobial drugs supervision and guidance group.
Our hospital has established a continuing education training program, focusing on the training of the "Chinese People's **** and the State Drug Administration Law", "Medical Institutions Pharmaceutical Management Regulations", "Medical Devices Supervision and Management Regulations", "Antimicrobial Drugs Clinical Application Guiding Principles", "Antimicrobial Drugs Clinical Application Management Measures", "Prescription Management Measures", "Inner Mongolia Autonomous Region 20xx Antimicrobial Drugs Clinical Application Special Rectification activities program" and other laws and regulations, the basic theory of national drugs and medical care and the flag health bureau issued on strengthening the supervision and management of drugs, medical equipment, storage and preservation, the use of normative documents to improve the quality of personnel, and to further standardize the drugs, medical equipment from the procurement, acceptance into the warehouse and the storage and preservation of all aspects of the use of strictly in accordance with the provisions of the regulations. The personnel engaged in the work of drugs in direct contact with the drugs every year to carry out health checks, and establish a health file, to ensure that the use of drugs in the process of safety and effectiveness.
Second, procurement and acceptance:
Strictly in accordance with the centralized purchasing system for medicines formulated by the higher-level health bureau for the procurement of medicines. Purchase of drugs from enterprises with the qualification of drug production and operation; acceptance of drugs into the warehouse in strict accordance with the standard operating procedures, strictly in accordance with the statutory quality standards and contractual quality terms of the quality of the purchased drugs, returned after the sale of drugs batch by batch inspection and acceptance.
Three, the implementation of standardized pharmacy management system:
Strictly in accordance with the standards of standardized pharmacy, the management of the hospital's Mongolian and Western pharmacy, pharmacy.
Fourth, drug storage and maintenance:
Warehouse is divided into a drug warehouse, medical equipment warehouse, each warehouse are divided into qualified area, pending inspection area, unqualified area, each area in accordance with the provisions of the implementation of the color-coded management, i.e., the qualified area for the green, pending inspection, the return of the area of the yellow, the failure of the area for the red. After acceptance, in strict accordance with the drug storage, maintenance system of drug storage, categorized storage, according to the drug storage conditions and requirements of the storage in the appropriate library area, the drug according to the batch number, the expiration date of centralized stacking, according to the batch number and the validity of the near and far or separate stacking, the near-expiry date of the drug to fill in the validity of the table every month.
Fifth, the allocation of drugs:
Pharmacy staff to allocate drugs, must be with a registered medical practitioner issued by the prescription, non-physician prescription shall not be allocated drugs, drug allocation work in strict accordance with the requirements of the four checking ten pairs of allocation, the issuance of the first to follow the "first produced first out of", "the near future, the first to be issued", "the first to be issued", "the first to be issued", "the first to be issued", "the first to be issued", "the first to be issued". "The first thing you need to do is to make sure that you have a good understanding of what you are doing and how you are doing it.
Six, adverse reaction monitoring:
The establishment of adverse drug reaction monitoring management team, designated full-time or part-time personnel responsible for adverse drug reaction reporting and monitoring work, the establishment and preservation of the adverse drug reaction monitoring file, take the initiative to collect the adverse drug reaction, through the National Adverse Drug Reaction Monitoring Information Network Reporting, report content should be true, complete and accurate. The report should be true, complete and accurate.
Specialty medicines:
Specialty medicines have safety storage measures in accordance with the provisions of the implementation of the double double locks, the account is consistent with the management of the five special. Purchase of special drugs should be carried out on arrival that inspection, double open boxes, count to the smallest package, and have a special acceptance records, return, expiration, unqualified special management of drugs and the provisions of the recovery of waste should be destroyed under the supervision of the health department, the destruction of records should be consistent with the to be.
VIII. Problems found in the inspection:
Through the self-checking team of the hospital use of drugs in all aspects of quality management work on self-checking, from the personnel organization, management system, hardware and facilities, management records to carry out a comprehensive and detailed self-checking, basically to meet the requirements of the use of drugs and quality management regulations, but also found some However, some shortcomings were found, such as poor hygiene, untidy arrangement of medicines, lack of standardization of sorting, lack of obvious zoning, lack of detailed writing records, etc., in individual places involving medicines, such as the drugstore, pharmacy, and pharmacy of outpatient department. Ordered the relevant personnel in each department must be according to the system to seriously rectify, and implement to the person.
Nine, the rectification of the situation:
I hospital in the self-inspection and mutual inspection on the basis of the rectification of the following problems:
1, the development of the system of confusing medicines and marking, and affixed next to the classification of out of the confusing medicines.
2. The system of on-the-job education and training and the training program focusing on ethnomedicine have been developed.
3, developed a medical device purchase inspection record system.
4, developed a medical device adverse event monitoring system.
5, strengthened the care and maintenance of large medical equipment. The medical equipment inspection, maintenance and related records were made up and will be implemented for a long time.
6, strengthened the adverse reaction and medical device adverse event monitoring.
In the actual work and implementation, there may be some easily overlooked, subtle aspects of the problem, hope that the higher leadership of the work of our hospital to put forward valuable advice. In the future work, we will certainly make persistent efforts to do a better job of our hospital's pharmaceutical work, to protect the people's 'drug safety.
Self-inspection report on drugs and devices 3
Since the Tiexi District Food and Drug Administration organized the "Tiexi District Drugs and Medical Devices Quality and Safety Remediation Mobilization Conference", I actively participate in the cooperation, and immediately organized the establishment of self-inspection team, the hospital's drugs and medical devices quality and safety situation to conduct a comprehensive mapping, the results of the self-inspection is reported as follows.
2. Duty management: Our hospital has established a management system including: drug and medicine procurement and acceptance system; drug and medicine storage system; drug adverse reaction (event) monitoring and reporting system; drug deployment and review system; drug and medicine storage and maintenance system; medical staff post responsibility system; safety and health management system. The above systems are complete, reasonable, feasible, and have the corresponding implementation records.
3. Drugs, medicines and equipment purchase and sale management: our hospital by the professional staff assigned to the procurement, quality inspection and acceptance of work; from the legal production and operation of enterprises to purchase drugs and medical equipment, and signed a quality agreement with the supplier enterprises, with legal bills; acceptance of personnel in strict accordance with the development of the inventory acceptance system and operating procedures for the acceptance of drugs and medicines, and to keep a complete record of the purchase and acceptance of records.
4. Pharmacy management: our hospital has a comprehensive pharmacy, safety and hygiene, sign conspicuous; pharmacy division of the appropriate functional areas, so that the drugs according to the dosage form classified and placed in a neat and orderly manner; the bureau is equipped with anti-rodent and anti-mosquito facilities; pharmacy staff in the dispensing of prescriptions can be strictly audited in accordance with the system of dispensing and operating practices for the deployment, and according to the requirements of the daily inspection of medicines, such as in the event of damage or expired drugs reported by the The company's business is to provide the best possible service to its customers.
5. Pharmacy management: our hospital pharmacy partition is distinct and reasonable, the distance of drug storage is appropriate, according to the requirements of the classification, sub-dosage form at room temperature storage of drugs; management personnel can be strictly in accordance with the requirements of the custody of drugs; drugs out of the warehouse to follow the principle of "first in, first out," the record is complete.
The above is the existing situation of the quality and safety of drugs and medical devices in our hospital, in the future work, we will further improve.
Self-inspection report on drugs and devices 4
According to the xxx County Food and Drug Administration "on the development of township health centers, village health clinics, individual clinics, the use of drugs, medical equipment safety special rectification notice", our hospital actively participate in the cooperation and immediately organize the establishment of a self-inspection team, the use of the hospital's medicines, medical equipment to carry out a comprehensive mapping, the results of the self-inspection are reported as follows:
I hospital has established the management system includes: drugs and medicines procurement acceptance system; drugs and medicines in and out of the warehouse system; drugs and medicines storage and maintenance system; medical staff post responsibility system; safety and health management system.
Second, the purchase and sale of drugs and medicines management
Our hospital does not exist from the unqualified units, individuals, the purchase of drugs, medical equipment; according to the provisions of the acceptance and fill in the true and complete acceptance records, inspection, request for information; there is no use of expired and invalid drugs and medical equipment.
Third, the management of the drugstore
Our hospital drugstore safety and hygiene, signs are conspicuous. The drugstore partition is distinct and reasonable, so that the drugs according to the dosage form of classification, neat and orderly. Drugs are stored in accordance with the prescribed conditions, to achieve the dust, moisture, heat, moth, anti-theft, etc., equipped with a refrigerated cabinet to put drugs. There is a corresponding pharmacy drug quality management system and implementation records.
The above is the existing situation of the safe use of drugs and medical devices in our hospital, and we will further improve it in the future.
Self-inspection report on medicines and devices 5
To protect the people of the county with medicines and medical devices effective, I store special organization of the relevant personnel on the store medicines and medical devices to carry out a comprehensive inspection, now report the specifics of the situation is as follows:
A strengthened responsibility, to enhance the awareness of the responsibility for quality. The first step is to make sure that you are aware of the importance of the quality of the product. The store has established and improved a series of drug and medical equipment related systems: drug and medical equipment substandard treatment system, medical equipment adverse event supervision and management system, medical equipment storage, maintenance, use, maintenance system, etc., to ensure that the system to ensure that the hospital clinical work of the safe and smooth operation.
Second, in order to ensure the quality of purchased drugs and medical equipment and the use of safety, to prevent the entry of unqualified drugs and medical equipment, the store specially formulated drugs and medical equipment purchase management system. The conditions for the purchase of drugs and medical equipment and the qualifications of suppliers have made strict provisions.
Third, in order to ensure the legal and quality of medical equipment, we seriously implement the system of storage of drugs and medical equipment to ensure the safe use of medical equipment.
Fourth, do a good job of daily storage
Fifth, in order to ensure that the quality of stored medicines and medical equipment in the library, we also organize special personnel to do a good job of daily maintenance of medicines and medical equipment.
Six, to strengthen the management of unqualified drugs and medical equipment, to prevent unqualified drugs and medical equipment
into the store, the store specially formulated adverse event reporting system. If there is an adverse event of medicines and medical devices, we should find out the location, time, adverse reactions or adverse events, and make a good record, and quickly reported to the county drug and medical device supervision and management bureau.
VII, the focus of my future work on drugs and medical devices, and effectively strengthen the safety of drugs and medical devices in the store, to prevent the occurrence of drug and medical device safety time, to ensure that the majority of patients with drug and medical device safety, in the future work, we intend to:
1, to further increase the publicity of the safety of drugs and medical devices, the implementation of the relevant system, to improve the store's drug and medical device safety awareness of the responsibility. Medical device safety awareness of responsibility.
2, to increase the store's drug and medical device safety daily inspection, supervision and frequency, timely investigation of drug and medical device safety hazards, firmly establish the "safety first awareness, customer service.
3, continue to cooperate actively with the higher authorities, consolidate the results of the hospital drug and medical equipment safety work, *** with the creation of a good atmosphere of drug and medical equipment, in order to build a harmonious society to make greater contributions.
Self-inspection report on drugs and devices 6To implement the "xx city to rectify the city's medical device circulation area business practices" (hundred food and drug supervision office {20xx}88) the spirit of the document, I attach great importance to the company, on July 8, 20xx by the company's quality management department of the company's relevant positions in the organization in accordance with the contents of the bulletin combined with the company's actual item-by-item to carry out a serious self-inspection work, now will be reported as follows. Self-inspection is now reported as follows:
(a) engaged in the wholesale business of medical equipment business enterprise sales to non-qualified business enterprises or the use of units; medical equipment business enterprises from the non-qualified production and operation of medical equipment purchased from the enterprise.
Self-inspection: our company's purchasing and sales channels are legal, strictly in accordance with the relevant requirements of the state audit of the supply unit and the purchase of units of legal qualifications, the company's all the supply unit and the purchase of units of legal qualifications, effective.
(B) changes in business conditions, no longer meet the requirements of the quality management standard for medical device business, not in accordance with the provisions of the rectification; unauthorized change of business premises or warehouse address, expand the scope of business or unauthorized establishment of the warehouse. Self-inspection: Our company strictly in accordance with the requirements of the quality management standard for the operation of medical devices to carry out business, there is no unauthorized change of business premises or warehouse address, expanding the scope of business or unauthorized establishment of the illegal act of the warehouse.
(C) provide false information or take other deceptive means to obtain a "medical device business license"; not for the record or the record to provide false information; forged, altered, trading, leasing, lending, "medical device business license" or "medical device business record certificate.
Self-inspection: Our company solemnly undertakes: for the "Medical Device Business License" to provide information is true, accurate and complete, there is no forgery, alteration, trading, leasing, lending the "Medical Device Business License" of illegal behavior.
(D) unauthorized to engage in the third class of medical equipment business activities, or "Medical Device License" expires after the continuation of the law, still continue to engage in the operation of medical equipment.
Self-inspection: my company's "Medical Device License" is valid until September 27, 20xx, at present my company is actively preparing for the renewal of the license.
(E) the operation of medical devices without obtaining a medical device registration certificate of the second class, the third class of medical devices, especially imported medical devices in the territory of the agent operating unlicensed products.
Self-inspection: our company's purchase and sales channels are legal, not over the scope of business.
(F) business does not meet the mandatory standards or do not meet the technical requirements of the registered or filed products of medical devices; business without qualified documents, expired, expired, out of medical devices.
Self-inspection: our company in accordance with the approved mode of operation, the scope of business engaged in the operation of medical devices; not operating without a qualified document, expired, invalid, out of medical equipment.
(G) the operation of medical devices, instructions, labels do not meet the relevant provisions; not in accordance with the instructions and labels of medical devices labeling requirements for the transportation and storage of medical devices, in particular, the need for low-temperature, refrigerated medical devices to carry out the whole chain of cold chain management.
Self-inspection: our company's medical devices instructions, labeling in line with the relevant provisions; our company does not operate the need for refrigeration medical devices.
(H) not in accordance with the provisions of the establishment and implementation of the medical device purchase inspection records system; engaged in the second class, the third class of medical equipment wholesale business and the third class of medical equipment retail business business business enterprises are not in accordance with the provisions of the establishment and implementation of the sales record system.
Self-inspection: has been in accordance with the provisions of the implementation of medical equipment purchase inspection and sales record system.
Through this self-examination and self-correction work, more standardized and supervise our business behavior, in order to the company's healthy and sustainable development, to better serve the people, in the future operation of the work we will, as always, in strict accordance with the food and drug supervision and management departments deployed to carry out the work required to put the quality of the gate, to ensure that the people of the people with the device safe and effective.
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