Self-inspection report on drugs and medical devices
The hard work inadvertently has come to an end, looking back at the past period of time, there are surprises, there are also shortcomings, it is time to take the time to write a self-inspection report. Then the general self-examination report is how to write it? The following is my collection of self-inspection report of the pharmacy medical equipment, I hope to help you.
Self-inspection report on drugs and medical devices 1
In order to implement the "xx city to rectify the city's medical device circulation area business behavior program" (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 to organize the company's relevant positions in accordance with the contents of the bulletin combined with the company's actual item-by-item carefully Carried out self-examination, now the self-examination is 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 the operation of medical devices, not in accordance with the provisions of the rectification; unauthorized change of business premises or warehouse address, expand the scope of business or set up a warehouse without authorization. Self-examination: my 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 license"; not for the record or record false information; forgery, alteration, sale, lease, loan, "Medical Device License" or "medical device business filing 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, sale, lease, loan "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 equipment without obtaining a medical device registration certificate of the second class, the third class of medical devices, especially imported medical equipment in the territory of the agent operating unlicensed products.
Self-inspection: the company's purchase and sale of legal channels, not over the scope of business.
(F) does not meet the mandatory standards or do not meet the technical requirements of the registered or filed products of medical devices; operating without qualified documents, expired, invalid, out of medical equipment.
Self-inspection: our company in accordance with the approved mode of operation, the scope of business engaged in the operation of medical equipment; not operating without a qualified document, expired, invalid, obsolete medical devices.
(G) the operation of medical devices, instructions, labels do not comply with 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: my company operates medical devices. Instructions, labeling in line with the relevant provisions; my company does not deal with the need to refrigerate medical devices.
(H) not in accordance with the provisions of the establishment and implementation of the medical device purchase inspection record 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-inspection 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 requirements of the deployment of the food and drug supervision and management departments to carry out their work, the quality of the gate, to ensure that the people of the people with the device safe and effective.
Self-inspection report on drugs and medical devices2
In order to ensure that the people of the county with drugs and medical devices effective, I store special organization of the relevant personnel on the store drugs and medical devices to carry out a comprehensive inspection, now the specific situation is reported as follows:
First, to strengthen the responsibility, enhance the awareness of the responsibility of the 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 as well as the qualifications of the supplier have made strict provisions.
Third, in order to ensure that the legal and quality of medical equipment, we conscientiously implement the drug and medical equipment warehousing system to ensure the safe use of medical equipment.
Fourth, do a good job of daily storage.
Fifth, in order to ensure the quality of the storage of drugs and medical equipment in the library, we also organize special personnel to do a good job in the daily maintenance of drugs and medical equipment.
VI. Strengthen the management of unqualified drugs and medical equipment to prevent unqualified drugs and medical equipment.
Into the store, our store specially formulated adverse event reporting system. If there is an adverse event of drugs and medical devices, you should find out the location, time, adverse reactions or adverse events of the basic situation, and make a good record, and quickly reported to the County Drug and Medical Device Supervision and Administration.
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 eliminate 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, 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.
2, to increase the safety of drugs and medical devices in the store daily inspection, supervision and frequency, timely investigation of drugs and medical equipment 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 drugs and medical equipment, to build a harmonious society to make greater contributions.