Part I special drugs management self-examination report
Received the Shijiazhuang Municipal Bureau of Health on the "forwarded to the Provincial Department of Health to strengthen the management of special drugs of the Emergency Circular," after the organization of the relevant personnel of the hospital to actively carry out self-checks, self-examination of the situation is as follows:
1, anesthesia drugs, psychotropic drugs, regulations and systems, and a clear responsibility.
2, narcotic drugs, psychotropic drugs practitioners, pharmacy staffing requirements, qualified training.
3, narcotic drugs, a class of psychotropic drugs for the standardization of procedures, patients with anesthesia this regular follow-up follow-up supervision is not strict, part of the licensed physician issued narcotic drugs, psychotropic drugs part of the prescription does not comply with the provisions of the phenomenon of the existence of outpatient prescription overdose.
4, narcotic drugs, psychotropic drugs, the use of special safes to save, and set up anti-theft doors and windows, to achieve 24-hour duty.
5, the patient's remaining narcotic drugs, a class of psychotropic drugs recovery and destruction records are not sound. In response to the above problems, the following corrective measures were made in a timely manner:
(1) All qualified physicians with narcotic drugs, a class of psychotropic drugs for in-hospital training, standardize prescription dosage, read the relevant laws and regulations, to strengthen the sense of responsibility, standardize the use of.
(2) Implementation of the new narcotic drugs, a class of psychotropic drugs special card, standardize the process.
(3) the strict implementation of the remaining narcotic drugs, a class of psychotropic drugs recovery and destruction management system, the establishment of recovery registration files, make a good record of recovery, and in strict accordance with the provisions of the implementation.
Part II special drugs management self-examination report
** City Food and Drug Administration:
My company according to the "on the organization of special drugs production and management enterprises to carry out self-examination and self-correction work notice", against the actual situation of the company, carried out a serious cross-checking, my company is now self-examination report:
The situation is as follows:
The company is now self-examination report. As follows:
1, our company does not have narcotic drugs, psychotropic drugs (Class I, Class II) business scope.
2, after self-examination of the company so far only in ** years ** month ** from Jiangsu Fosun Pharmaceutical Sales Limited purchased the compound licorice tablets (Guilin South Pharmaceutical Co., Ltd. production, 100 tablets/bottle) 600 bottles, so far, there is no sale to customers. No other related varieties are operated.
3, for the purchase of such drugs, receipt, acceptance into the warehouse, sales and other work of the company have designated a person responsible for.
4, the quality control department strictly audit and retain the supplier, purchaser and sales staff, purchasing staff of the legal qualifications and copies of identity cards, request for information is complete, the records are true and complete, and can be filed in a timely manner.
5, the purchase and acceptance of such drugs in line with the company's relevant management system and laws and regulations.
6, the sale of such drugs is strictly enforced, "wholesale enterprises directly purchased from the manufacturer of drugs, can be sold to other wholesale enterprises, retail chain stores and medical institutions; purchased from the wholesale enterprise, can only be sold to the province (region, city) of the retail chain stores and medical institutions. Strictly prohibit the sale of such drugs to all kinds of units or individuals without legal qualifications.
7, our company's procurement and sales of special drugs containing compound preparations, prohibit the use of cash for transactions, and in accordance with the provisions of the demand and invoicing, to achieve the ticket, account, goods consistent, standardized management of bills.
8, the company's sales of compound preparations containing special drugs, the strict implementation of the warehouse review system, carefully check whether the physical and sales out of warehouses in line with the bill, and to ensure that the drugs are delivered to the buyer's "Drug License" contained in the address of the warehouse, the address of the drug retailer's registered address, or the medical institution's pharmacy. After the delivery of the drugs, the purchaser should check the goods, and the consignee should sign the accompanying goods list after the goods are correct. The original of the accompanying list shall be kept, and the copy shall be stamped and returned to our company in time. The quality control department of the company should check whether the content of the returned copy of the accompanying list is abnormal and archived.
After this self-inspection, to promote the safety management of special drugs in our company, in the future business work will be more stringent requirements to do a good job in all aspects of the work. The above is my company's self-examination of the situation, please Kunming Food and Drug Administration leadership inspection and guidance!
Part III special drugs management self-inspection report
My company in accordance with the State Food and Drug Administration on the implementation of the medical device business quality management standard announcement (No. 58 of 201x) the spirit of the document, the organization of the relevant personnel focus on my company's operation of all the medical equipment to carry out a comprehensive inspection, now the specific situation is reported as follows. Now the details are reported as follows:
First, strengthen the system management, improve the quality management system, to ensure the quality and safety of products in the process of operation
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 of the 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 the system.
Part IV Special Drug Management 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 my pharmacy strictly in accordance with the "Drug Retailer GSP", "on-site inspection guiding principles" to carry out the inspection of the pharmaceutical retail business, and to ensure that the system is effectively implemented. On-site 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, hygienic and clean, and 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 aspects, 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 seriously audits the qualifications of the supplying units and their sales personnel, is responsible for auditing the legality of purchasing drugs, guiding and supervising the quality management work of drug purchasing, storing, displaying, selling and other aspects of the work, seriously doing the work of drug quality inquiries and quality information management, confirming and dealing with the unqualified drugs, being responsible for the report of adverse reactions of the fake and shoddy drugs, and doing the work of education and training on the quality management of the drugs seriously. The quality manager is also responsible for the review and control of the operation authority of the computer system and the maintenance of the basic data of quality management, as well as the calibration and verification of the measuring instruments, and guiding and supervising the pharmacy service. 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, Guidance on rational use of medication and other pharmacy services management system, personnel training and assessment system, adverse drug reaction reporting system, computer system management system, the implementation of electronic monitoring system for drugs, the development of the head of the enterprise, quality management, purchasing, acceptance, sales staff, as well as prescription review, dispensing and other positions 's responsibilities. Established a dozen operating procedures for drug purchasing, acceptance, sales, prescription review, deployment, checking and so on.
Established records related to drug purchasing, acceptance, sales, display inspection, temperature and humidity monitoring, unqualified drug treatment, etc., to be 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, scale of operation is appropriate. Enterprise business area of XX square meters, clean environment, reasonable layout, well ventilated, no pollutants, business premises, living area 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. There is one temperature and humidity meter, one dehumidifying appliance, one ventilation fan, one sticky rodent board, and it is equipped with the mixing tools and packaging supplies necessary for the split-sale of medicines in compliance with the requirements. And there is a special cabinet containing ephedrine.
(E) procurement and acceptance of drugs
1, drug procurement
Drug procurement management is a key link to ensure the quality of 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 (tickets) to verify the drugs in kind, so that the tickets and accounts in line with the goods.
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, regular summary, analysis and reporting of drug maintenance quality information.