A self-examination report on the operation and management of special drugs

After receiving the "Emergency Notice of Forwarding the Provincial Health Department to Strengthen the Management of Special Drugs" from the Shijiazhuang Municipal Health Bureau, our hospital organized relevant personnel Actively conduct self-examination. The self-examination situation is as follows:

1. The rules and regulations for narcotic drugs and psychotropic drugs are sound and the responsibilities are clear.

2. The staffing of narcotic drugs, psychotropic drugs practitioners and pharmaceutical personnel meet the requirements and the training is qualified.

3. The procedures for handling narcotic drugs and Class I psychotropic drugs are standardized, and supervision of regular follow-up visits for anesthetized patients is not strict. Some prescriptions issued by some practicing doctors for narcotic drugs and psychotropic drugs do not comply with the regulations, and there are outpatient prescriptions. excess phenomenon.

4. Narcotic drugs and psychotropic drugs should be kept in special safes, with anti-theft doors and windows set up to ensure that there are people on duty 24 hours a day.

5. The recovery and destruction records of patients’ remaining narcotic drugs and Class I psychotropic drugs are incomplete. In response to the above problems, the following corrective measures were taken in a timely manner:

(1) Conduct in-hospital training for all doctors with narcotic drugs and Class I psychotropic drugs qualifications, standardize prescription dosage, read out relevant laws and regulations, strengthen awareness of responsibility, and standardize use .

(2) Implement new special cards for narcotic drugs and Class I psychotropic drugs, and standardize the processing procedures.

(3) Strictly implement the recycling and destruction management system for remaining narcotic drugs and Class I psychotropic drugs, establish recycling registration files, keep recycling records, and strictly implement them in accordance with regulations.

Part 2 Self-examination Report on Operation and Management of Special Drugs

** Municipal Food and Drug Administration:

Our company is based on the "About Organizing Special Drug Production and Operation Enterprises" "Notice on Carrying out Self-examination and Self-Correction Work", we have conducted a careful comparative inspection based on the actual situation of the company. Our company now reports the self-inspection situation as follows:

1. Our company does not have narcotic drugs or psychotropic drugs ( Category I and Category II) business scope.

2. After self-inspection, the company has only purchased compound licorice tablets (produced by Guilin Nanyang Pharmaceutical Co., Ltd., 100 tablets) from Jiangsu Fosun Pharmaceutical Sales Co., Ltd. on **month**, **year /bottle) 600 bottles, which have not been sold to customers so far. No other related varieties are operated.

3. The company has designated dedicated personnel to be responsible for the procurement, receipt, inspection and storage, and sales of such drugs.

4. The quality control department strictly reviews and retains the legal qualifications and ID copies of suppliers, buyers, sales personnel, and purchasing personnel. The requested information is complete, the records are true and complete, and can be archived in a timely manner. .

5. The purchase and acceptance of such drugs comply with the company’s relevant management systems, laws and regulations.

6. The sales of this type of drugs strictly follow the "wholesale companies that purchase drugs directly from production companies can sell drugs to other wholesale companies, retail chain stores and medical institutions; those who purchase from wholesale companies, It can only be sold to retail chain stores and medical institutions in this province (region, city)." It is strictly prohibited to sell such drugs to various types of units or individuals without legal qualifications.

7. When our company purchases and sells compound preparations containing special drugs, it is prohibited to use cash for transactions, and invoices must be requested and issued in accordance with regulations to ensure that invoices, accounts, and goods are consistent, and invoice management is standardized.

8. When the company sells compound preparations containing special drugs, it strictly implements the outbound review system, carefully checks whether the physical objects are consistent with the sales outbound order, and ensures that the drugs are delivered to the buyer's "Drug Business License". The stated warehouse address, the registered address of a drug retail enterprise, or the drug warehouse of a medical institution. After the medicine is delivered, the buyer should inspect the goods, and if they are correct, the consignee will sign the accompanying slip. Keep the original copy of the accompanying receipt, and return the copy to our company promptly after being stamped with the official seal. The company's quality control department should check whether there are any abnormalities in the returned copy of the shipping slip and keep it on file.

After this self-examination, our company has promoted the safety management of special drugs, and will be more stringent in all aspects of work in future operations.

The above is the self-examination of our company. Please ask the leaders of Kunming Food and Drug Administration for inspection and guidance!

Part 3 Self-examination Report on Operation and Management of Special Drugs

Our company complies with the announcement of the State Food and Drug Administration on the Implementation of Quality Management Standards for Medical Device Operations (No. 58, 201x) In the spirit of this, we have organized relevant personnel to conduct a comprehensive inspection of all medical devices operated by our company. The specific situation is now reported as follows:

1. Strengthen system management, improve the quality management system, and ensure the safety of products during the operation process. Quality and Safety

The company has established a safety management organization with the general manager as the main leadership core, department managers as the main organizational members, and all employees as the main supervisory and executive members, and has incorporated the management of medical device safety into the work of our company Top priority. Strengthen leadership, strengthen responsibility, and enhance awareness of quality responsibility.

The company has established and improved a series of management systems related to medical devices: effective quality control measures have been taken in the procurement, acceptance, storage, sales, transportation, after-sales service and other aspects of medical devices to protect the company's business activities with systems. safety and smooth progress.

2. Clarify job responsibilities, strictly manage the system, improve and save relevant records or file management systems

The company has strict requirements in every link from the general manager to the quality director to employees in each department In accordance with the quality management standards for medical device operations, we have formulated corresponding management systems and made strict regulations on the conditions for purchased medical devices and the qualifications of suppliers to ensure the quality and safety of purchased medical devices and prevent errors. Qualified medical devices enter the hospital. Ensure the legality and quality of warehousing medical devices, conscientiously implement the warehousing and warehousing system, and ensure the safe use of medical devices.

The person in charge of enterprise quality is responsible for the quality management of medical devices and has independent decision-making power. He mainly organizes the formulation of the quality management system, guides and supervises the implementation of the system, and inspects, corrects and corrects the implementation of the quality management system. Continuously improve, timely collect laws, regulations and other relevant provisions related to medical device operations, and implement dynamic management. Real-time supervision of the confirmation of unqualified medical devices, collection and reporting of adverse events, quality complaints and device recall information, and regular organization or assistance in quality management training. The company has transformed and upgraded all computer systems in accordance with the requirements of the new version of the equipment operation quality management specifications. It has installed the latest version of the New Spacetime software system to meet the entire process management and quality control of medical equipment operation, and has established relevant records and files. In the case of incomplete qualifications of some archived suppliers, supplements are requested in a timely manner for further improvement and preservation.

3. Personnel Management

Our company’s medical device work is performed by professional and technical personnel, and regular training on relevant laws, regulations and related systems is carried out to ensure the smooth progress of the work; every year we organize direct Staff who come into contact with medical devices undergo health examinations and keep health records.

IV. Warehousing management

The company has hardware facilities and equipment that meet the requirements for warehousing, acceptance and storage and transportation of medical devices. Medical devices are stored independently and classified, and devices and non-devices are separated. Storage, and has established the latest warehousing management system and medical device maintenance system, strengthens the quality management of stored devices, and has dedicated personnel to do daily maintenance of the devices. Prevent substandard medical devices from entering the market and develop an adverse accident reporting system.

Our company has always adhered to the quality policy of "quality first, customer first" and strictly followed the requirements of the "Good Manufacturing Practice for Medical Device Operations", increased inspections of medical device safety items in the warehouse, timely checked medical device hidden dangers, and regularly Self-examination to ensure effective implementation of various systems.

Part 4 Self-examination Report on Special Drug Operation and Management

According to the requirements of the "Drug Administration Law" and its implementation regulations and the "Drug Operation and Quality Management Practices", in order to make XXX Pharmacy as soon as possible Through GSP certification, under the guidance of the xx Food and Drug Administration, our pharmacy conducted a self-inspection in strict accordance with the "Guiding Principles for GSP On-site Inspection of Drug Retail Enterprises". The relevant situation is now reported as follows:

1. Basics Situation

XXX Pharmacy is an independent pharmacy. There are no pollution sources and no high-risk facilities around the business address. The business premises are spacious and bright, hygienic and clean, and the layout is reasonable. The approved business scope of the pharmacy is: Chinese herbal medicines, Chinese patent medicines, chemical pharmaceutical preparations, antibiotic preparations, and biochemical drugs.

In accordance with GSP requirements, our pharmacy has improved the corresponding equipment, revised the responsibilities of each position and related regulations, and carried out GSP transformation from both hardware and software aspects, and has achieved good results. This pharmacy insists on operating in accordance with the law, being honest and trustworthy, and does not commit any deception in GSP certification and daily operations.

2. Enterprises’ implementation of GSP self-examination

(1) Quality management and responsibilities

Our pharmacy complies with relevant laws and regulations and the "Good Manufacturing Practice for Pharmaceutical Operations" According to the requirements, we have formulated quality management documents and carried out quality management activities to ensure the quality of medicines. Established operating conditions suitable for the business scope and scale of the pharmacy, including organizational structure, personnel, facilities and equipment, quality management documents, and set up computer systems in accordance with regulations.

There is a quality manager XXX who is responsible for the quality of drugs and has formulated quality management documents. The quality manager carefully reviews the qualifications of the supplier and its sales staff, is responsible for reviewing the legality of purchased drugs, guides and supervises the quality management of drug procurement, storage, display, sales and other links, and carefully conducts drug quality inquiries and quality inspections. Information management work, confirming and processing substandard drugs, responsible for reporting adverse reactions of counterfeit and substandard drugs, conscientiously doing drug quality management education and training, review and control of computer system operation authority, maintenance of basic quality management data, and measurement Calibration and verification of equipment, guide and supervise pharmaceutical services. Responsible for other duties that should be performed by the Quality Manager.

(2) Personnel management

The personnel engaged in drug operation and quality management in our pharmacy comply with relevant laws, regulations and the requirements of the "Specifications", and there is no industry ban. The person in charge of the company, XXX, has XXX pharmacist qualification and provides guidance on the rational use of medicines. The quality manager is XXX, who has the technical title of XXX pharmacist. The salesperson XXX has XX academic qualifications, and the Chinese medicine preparation staff XXX has XXX education (delete the sentence without Chinese medicine preparations).

Both XXX and XXX received pre-job training and continuing education training on relevant laws and regulations and pharmaceutical professional knowledge and skills. The company develops annual training plans and conducts training. Annual health examinations are conducted every year, health certificates are obtained, and health files are established to meet job requirements. Our pharmacy does not store items or personal items that are not related to business activities and does not affect the quality and safety of medicines.

(3) Documents

This pharmacy has formulated practical quality management documents in accordance with relevant laws and regulations, including quality management systems, job responsibilities, operating procedures, files, records and vouchers, etc. . And review it regularly and revise it in a timely manner. Through training, personnel in each position can correctly understand the content of quality management documents and ensure the effective implementation of quality management documents. It has also formulated a drug quality management system: a management system for drug procurement, acceptance, display, sales, storage, maintenance and other links, a supplier unit and procurement variety review system, and a prescription drug sales management system. Drug dismantling management system, specially managed drugs and drugs with special management requirements by the state, record and voucher management system, quality information collection and query management, quality accident and quality complaint management system, traditional Chinese medicine preparation review, deployment and verification management System, drug expiration date management system, substandard drugs and drug destruction management; environmental sanitation and personnel health system, pharmaceutical service management system such as medication consultation and guidance on rational drug use, personnel training and assessment system, adverse drug reaction reporting system, computer system management system , implement the electronic drug supervision system, and formulate the responsibilities of enterprise leaders, quality management, procurement, acceptance, sales staff, prescription review, and deployment, etc. More than a dozen operating procedures have been established for drug procurement, acceptance, sales, prescription review, deployment, and verification.

Relevant records such as drug procurement, acceptance, sales, display inspection, temperature and humidity monitoring, and disposal of unqualified drugs have been established to ensure that they are true, complete, accurate, effective, and traceable. Records and related vouchers should be kept for at least 5 years.

When recording data through the computer system, relevant personnel should log in to the computer system through authorization and password in accordance with operating procedures to enter data to ensure that the data is original, authentic, accurate, safe and traceable.

(4) Facilities and equipment

The company’s business premises are consistent with its pharmaceutical business scope and business scale. The business area of ??the enterprise is XX square meters, with a clean environment, reasonable layout, good ventilation, no pollutants, and separate business premises and living areas. There are XX sets of shelves for business use, XX sets of counters, and sales cabinets with eye-catching signs. Since we have legal and reliable drug supply channels, the drugs sold can be replenished in time and put on the shelves in time after passing the inspection. Therefore, our store does not have a warehouse. Medicine shelves and medicine cabinets can keep the distance between medicines and the ground at least 10cm. The pharmacy is equipped with dust-proof, moisture-proof, insect-proof, rodent-proof and other equipment. 1 thermometer and hygrometer, 1 dehumidifier, 1 ventilation fan, 1 sticky mouse board, equipped with dispensing tools and packaging supplies required for dismantling and selling of pharmaceuticals that meet the requirements. And there is a special counter containing ephedrine.

(5) Procurement and acceptance of drugs

1. Drug procurement

Drug procurement management is a key link in ensuring the quality of drug operations. Implement effective supervision and control over the drug procurement process. In order to strengthen the management of drug procurement, we first formulated a strict procurement management system during the procurement process, and carried out effective supervision on specific matters in the procurement process, the first-run enterprise and the purchase and sale contract. Control and regulations.

(1) Legality of purchasing enterprises

Conduct legality assessments on qualified suppliers and first-run enterprises. The purchaser is responsible for obtaining relevant information from the supplier, such as stamped The pharmaceutical production or operation license with the original seal of the enterprise, a copy of the business license and its annual inspection certificate, a copy of the "Good Manufacturing Practice for Pharmaceutical Manufacturing Practice" certification or the "Good Manufacturing Practice for Pharmaceutical Distribution" certification, relevant seals, and accompanying goods slips ( (ticket) format, account opening name, opening bank and account number, copies of "Tax Registration Certificate" and "Organization Code Certificate", fill in the approval form for first-run enterprises through investigation and understanding, and be reviewed and qualified by the quality manager, and have the person in charge of the pharmacy After approval, a qualified supplier file will be established.

(2) Legality of purchasing drugs

When purchasing drugs, buyers should ask for invoices from the supplier. The invoice should list the generic name, specification, unit, quantity, unit price, amount, etc. of the drug; procurement records should be established for purchasing drugs. Procurement records should include the generic name, dosage form, specification, manufacturer, supplier, quantity, price, purchase date, etc. of the drug.

(3) Signing of the legality and quality assurance agreement of the supplier's salesperson

Check the business behavior of the supplier's salesperson and the operation approved by the company's "certificates and licenses" Whether the method and business scope are consistent. Obtain a copy of the salesperson's ID card with the original seal of the supplier's salesperson; check the original seal of the supplier's official seal and the authorization letter with the seal or signature of the legal representative. The authorization letter should state the name and ID card of the authorized person. number, as well as the variety, region, and period of authorized sales; information on the supplier unit and supply variety.

The signing of the quality assurance agreement should clarify the quality responsibilities of both parties; the supplier should provide information that meets the regulations and be responsible for its authenticity and validity; the supplier should issue invoices in accordance with national regulations; pharmaceutical packaging , labels and instructions comply with relevant regulations; quality assurance and responsibilities for drug transportation; and the validity period of the quality assurance agreement.

The quality manager is responsible for verifying and auditing the above work, and the qualified materials will be entered into the qualified supplier's file together with the quality assurance agreement.

2. Drug acceptance

In order to ensure the quality of purchased drugs and prevent counterfeit and substandard drugs from entering our store, we have formulated management regulations for drug acceptance.

When the medicine arrives, the acceptance personnel should verify the physical substance of the medicine according to the purchase record and the accompanying receipt (invoice) of the supplier, so that the invoice and the goods match.

Enterprises shall inspect the incoming drugs batch by batch in accordance with prescribed procedures and requirements, and the samples taken for acceptance shall be representative. The acceptance personnel shall inspect and verify the appearance, packaging, labels, instructions and relevant supporting documents of the sampled drugs one by one.

According to the actual quality acceptance situation, the acceptance inspector will record the quality of the accepted drugs and make acceptance conclusions, and keep the acceptance records. Reject unqualified drugs and report to the quality manager.

(6) Display and storage

Our store strictly follows the requirements of the "Pharmaceutical Goods Management Practice" for the drugs it sells, and achieves the principle of four separations, that is, drugs and non-drugs , internal and external medicines are stored separately, prescription drugs and non-prescription drugs are placed in separate cabinets, drugs that are prone to odor are stored separately from general drugs, and are stored according to the characteristics of the drugs. Disassembled drugs are stored centrally in the dismantled counters, and the original packaging labels and instructions are retained.

The quality and packaging of the displayed drugs are in compliance with regulations. The quality of the displayed drugs is inspected every month and records are kept. If any problematic drugs are found, they are immediately removed from the shelves and counters, and relevant records are filled in. Keep the places and shelves where medicines are displayed clean and hygienic. There are fire-proof, moisture-proof, insect-proof, rodent-proof, and light-proof facilities and equipment.

In order to ensure the quality of drug storage, drug maintenance staff conduct regular monthly inspections of the drugs on display, and conduct weekly quality inspections of drugs that are perishable, near the expiration date, and easy to deliquesce. Any problems found are promptly taken. Effective treatment measures. At the same time, maintenance inspection records are kept, and drug maintenance quality information is regularly summarized, analyzed and reported.