Self-inspection report of pharmacy drugs 1

According to the requirements of the Drug Administration Law and its implementing regulations, and the Quality Management Standard for Pharmaceutical Trading, in order to make xxX pharmacy pass GSP certification as soon as possible, under the guidance of xX food and drug supervision department, our pharmacy conducted self-examination in strict accordance with the Guiding Principles for GSP on-site inspection of pharmaceutical retail enterprises, and now the relevant information is reported as follows:

I. Basic information

XXX pharmacy is a single pharmacy, with no pollution sources and high-risk facilities around its business address, spacious and bright business premises, clean and tidy, and reasonable layout. The approved business scope of the pharmacy is: Chinese herbal pieces, Chinese patent medicines, chemical preparations, antibiotic preparations and biochemical drugs. According to the requirements of GSP, the pharmacy in our hospital has improved the corresponding equipment, revised the responsibilities and related regulations of each post, and reformed GSP from both hardware and software, and achieved good results. This drugstore insists on operating according to law, is honest and trustworthy, and has no cheating in GSP certification and daily operation.

Second, enterprises implement GSP self-inspection

(A) quality management and responsibility

In accordance with the requirements of relevant laws and regulations and "Quality Management Standards for Pharmaceutical Trading", the pharmacy in our hospital has formulated quality management documents and carried out quality management activities to ensure the quality of drugs. Established the operating conditions suitable for the business scope and scale of this pharmacy, including organization, personnel, facilities and equipment, quality management documents, and set up a computer system according to regulations.

XXX is the main person responsible for drug quality, responsible for the daily management of pharmacies, ensuring that quality management personnel effectively perform their duties, and urging post personnel to implement the laws and regulations on drug management and the requirements of this specification. Equipped with quality administrator XXX to be responsible for drug quality, and formulated quality management documents. The quality manager carefully examines the qualifications of suppliers and their sales personnel, and is responsible for reviewing the legality of purchasing drugs.

Guide and supervise the quality management of drug procurement, storage, display and sales, conscientiously do a good job in drug quality inquiry and quality information management, confirm and deal with unqualified drugs, be responsible for reporting adverse reactions of counterfeit and inferior drugs, and conscientiously do a good job in drug quality management education and training, computer system operation authority review and control, quality management basic data maintenance, calibration and verification of measuring instruments, and guidance and supervision of pharmaceutical services. Responsible for other duties that should be performed by the quality manager.

(2) personnel management

The personnel engaged in drug management and quality management in our pharmacy meet the requirements of relevant laws and regulations and the Code, and there is no industry ban. XXX, the person in charge of the enterprise, has the qualification of XXX pharmacist to guide rational drug use. The quality administrator is XXX, and the technical title is XXX pharmacist. Clerk XXX education XXX, Chinese herbal medicine dispensing personnel XXX education XXX.

XXX and XXX received pre-job training and continuing education and training in relevant laws and regulations and pharmaceutical professional knowledge and skills. The enterprise has made an annual training plan and carried out training. Conduct annual health examination every year, obtain health certificates, establish health files, and meet post requirements. Our pharmacy does not store articles and personal items that have nothing to do with business activities and behaviors that affect the quality and safety of drugs.

(3) documents

The pharmacy in our hospital has formulated feasible quality management documents according to relevant laws and regulations, including quality management system, post responsibilities, operating procedures, files, records and vouchers. And review it regularly and revise it in time. Through training, personnel in all positions can correctly understand the contents of quality management documents and ensure the effective implementation of quality management documents. We have also formulated the drug quality management system: the management system of drug procurement, acceptance, display, sales, storage and maintenance, the audit system of suppliers and purchased varieties, the management system of prescription drug sales, the management system of drug dismantling, the management system of special management drugs and drugs with special management requirements in the country, the management system of quality information collection and inquiry, the management system of quality accidents and quality complaints, the management system of prescription review, deployment and verification of Chinese herbal pieces, the management system of drug expiration date, and the management system of drugs.

Reason; Environmental hygiene, personnel hygiene system, pharmaceutical service management system such as drug consultation and rational drug use guidance, personnel training and assessment system, adverse drug reaction reporting system, computer system management system, implementation of drug electronic supervision system, formulation of enterprise leadership responsibilities, quality management, procurement, acceptance, shop assistant, prescription review and deployment. More than a dozen operational processes, such as drug procurement, acceptance, sales, prescription review, deployment and verification, have been established.

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

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

(4) Facilities and equipment

The business place of the enterprise is suitable for the scope and scale of its drug business. The business area of the enterprise is XX square meters, with clean environment, reasonable layout, good ventilation and no pollutants, and the business place is separated from the living area. Commercial shelves XX group, counter XX group, sales cabinet group logo eye-catching. Because there are legal and reliable drug supply channels, the drugs sold can be replenished in time and put on the shelves in time after acceptance, so our store has no warehouse. The medicine rack and medicine cabinet can keep the distance between the medicine and the ground above 10cm. Drugstores are equipped with dust-proof, moisture-proof, insect-proof and rat-proof equipment. There are 1 hygrometer, 1 dehumidifier, 1 ventilator, 1 rat-sticking board, equipped with matching deployment tools and packaging supplies, which are used for drug sales. And there is a counter containing ephedrine.

(5) Procurement and acceptance of drugs

1, drug procurement

Drug procurement management is a key link to ensure the quality of drug management. In order to effectively supervise and control the drug procurement process and strengthen drug procurement management, we adopt

In the process of purchasing, a strict purchasing management system is first formulated, which effectively controls and stipulates the specific matters, the first enterprise and the purchase and sale contract in the purchasing process.

(1) Legitimacy of purchasing enterprises

To evaluate the legitimacy of qualified suppliers and start-up enterprises, the buyer is responsible for obtaining relevant information from the suppliers, such as the pharmaceutical production or business license stamped with the original seal of the enterprise, a copy of the business license and its annual inspection certificate, a copy of the quality management standard certificate of pharmaceutical business or a copy of the quality management standard certificate of pharmaceutical business, relevant seals, the attached bill (ticket) style, account name, and after investigation, fill in the bank and account number, a copy of the tax registration certificate and a copy of the organization code certificate in the approval form of the first-run enterprise, which will be audited by the quality administrator.

(2) the legality of purchasing drugs

When purchasing drugs, the buyer shall ask the supplier for an invoice. The invoice shall specify the generic name, specification, unit, quantity, unit price and amount of the drug;

Procurement records shall be established for purchasing drugs. The purchase records shall include the generic name, dosage form, specifications, manufacturer, supplier, quantity, price, purchase date, etc.

(3) The legitimacy of the supplier's salesman and the signing of the quality assurance agreement.

Check whether the business behavior of the supplier's salesman is consistent with the business mode and business scope approved by the company's License. Obtain a copy of the salesman's ID card of the supplier's salesman and the original official seal of the supplier; Check the original official seal of the supplier and the seal or signed power of attorney of the legal representative. The power of attorney shall specify the name and ID number of the authorized person, as well as the variety, area and time limit of the authorized sales; Information about suppliers and varieties.

The signing of the quality assurance agreement should clarify the quality responsibilities of both parties; The supplier shall provide materials that meet the requirements and be responsible for their authenticity and effectiveness; Suppliers shall issue invoices in accordance with state regulations; The packaging, labels and instructions of drugs comply with the relevant provisions; Quality assurance and responsibility of drug transportation; The validity period of the quality assurance agreement.

The quality manager is responsible for verifying and auditing the above work, and the qualified materials and quality assurance agreements are put into the files of qualified suppliers.

2. Acceptance of drugs

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

After the drug arrives, the inspector verifies the drug in kind according to the purchase record and the bills (tickets) attached by the supplier to ensure that the tickets and goods match.

Enterprises should check and accept the arrival drugs batch by batch according to the prescribed procedures and requirements.

The samples used for acceptance shall be representative. Inspectors shall inspect and check the appearance, packaging, labels, instructions and relevant supporting documents of the sampled drugs one by one.

According to the actual situation of quality acceptance, the inspector records the quality of the accepted drugs, makes the acceptance conclusion at the same time, and keeps the acceptance records. Reject unqualified drugs and report to the quality manager.

(6), display and storage

Our store strictly abides by the requirements of "Quality Management Standards for Pharmaceutical Trading" and implements the principle of "four separations", that is, drugs and non-drugs, drugs for oral use and drugs for external use are stored separately, prescription drugs and over-the-counter drugs are stored separately, easily-smelled drugs are stored separately from general drugs, classified according to the characteristics of drugs, disassembled drugs are stored in the disassembling counter, and the original packaging labels and instructions are kept.

The quality and packaging of the drugs on display meet the requirements. Check the quality of drugs on display every month and make records. If there is any problem with the drug, immediately remove the shelf and fill in the relevant records. Drug display places, shelves and counters shall be kept clean and hygienic. There are facilities and equipment that are fire-proof, moisture-proof, insect-proof, rat-proof and light-proof.

In order to ensure the storage quality of drugs, drug custodians regularly check the displayed drugs every month, and check the quality of perishable, near-effective and deliquescent drugs every week, and take effective measures in time when problems are found. At the same time, do a good job in maintaining inspection records, and regularly summarize, analyze and report drug maintenance quality information.

Self-inspection report of drugs in pharmacies II

Since the opening of our store, we have earnestly studied and implemented the Good Quality Management Practice for Pharmaceutical Trading (GSP). Establish and implement the rules and regulations in the store in strict accordance with GSP standards. Insist on managing enterprises according to GSP requirements. Self-examination is now carried out in accordance with the "Quality Management Standards for Pharmaceutical Trading" and "GSP Certification Inspection and Evaluation Standards for Pharmaceutical Retail Enterprises". The results of self-examination are as follows:

I. Overview of pharmacies

Our pharmacy was established in xxx, located in xxx, and its legal representative is xxx, the person in charge of the enterprise and the person in charge of quality. * * * There are 2 employees, including licensed pharmacist 1 person. Business nature: private, business mode: retail, business scope: (prescription drugs, over-the-counter drugs) chemical preparations, antibiotic preparations, biochemical drugs, Chinese patent medicines, family planning supplies, and stereotyped packaged food retail.

Second, the GSP quality system self-inspection.

Our store has set up a quality leading group with the legal representative as the leader and the quality director (licensed pharmacist) as the deputy leader, with a clear division of labor. Strictly implement national laws and regulations and the provisions of GSP. Engaged in drug business activities in strict accordance with the business mode and business scope stipulated in the Drug Business License, and hung "two certificates and one photo" and the original registration certificate of licensed pharmacists in a prominent position in the store. The person in charge of quality carefully checks and accepts the drugs handled by our store, so as to be FIFO, keep inspection records and report to the manager in time when problems are found. Since its opening, the qualified rate of purchase has been 100% and 100%. Individual damaged varieties should be exchanged with pharmaceutical companies in time to ensure the quality of drugs. Strengthen drug maintenance and ensure drug quality. The drugs displayed in the store are placed on the shelves in strict accordance with the Measures for the Administration of Drug Classification, and the temperature and humidity are maintained every day.

Record and register, check and maintain the drugs in stock once a month, and check and maintain the key drugs once on June 5438+05, register the near-effect drugs, check whether the appearance quality of the key drugs has changed, and report and deal with quality problems in time. And there's a medicine counter. The employees in the store always adhere to the standard operation, double inspection by two people, strict quality control, and the quality of drugs is well guaranteed, which is the customer's peace of mind and satisfaction.

Since the establishment of our store, we have obtained a lot of drug information provided by superior departments such as the US Food and Drug Administration. In addition, we have strengthened contact with supply pharmaceutical companies and manufacturers of the first variety, collected all kinds of medical information related to drugs in time through various channels, and actively communicated with peer units. Orders are ordered as planned at ordinary times, so that ledgers and records are kept at all times, and all work is standardized and institutionalized.

Third, ensure the safety and effectiveness of medication.

Strictly control purchases. Our store must purchase goods from pharmaceutical companies with certain qualifications and passed GSP certification, take quality as the primary condition for selecting drugs and suppliers, and strictly implement the principle of "purchasing on demand and purchasing on the basis of merit". The drugs purchased meet the statutory standards and relevant quality requirements, and we will resolutely not purchase from "unlicensed drug dealers". Due to strict control, there have never been any fake and shoddy drugs entering the store and quality complaints since the opening.

Strict inspection and acceptance. Warehouse acceptance is the second step to ensure the quality of drugs. The drug acceptance of our store is accepted by the quality director, who has the title of licensed pharmacist, has been engaged in drug management for many years, adheres to principles and has rich experience in drug management. Check and accept the purchased drugs in strict accordance with the relevant provisions of GSP, and register them in the warehouse through the drug supervision network.

Strictly control sales. Adhere to the pharmacist's on-the-job service, establish the service standard for employees in retail links and the knowledge meeting of each post, sell prescription drugs according to doctors' prescriptions, and allocate them according to prescriptions, formulas, verification and distribution. Strive to improve the service level and constantly improve the comprehensive professional quality of employees. Organize regular training and study. The staff dressed in the clothes were put on their posts, dignified in appearance and full of spirit, insisting on asking questions to sell drugs and guiding customers to use drugs safely and reasonably. Free blood pressure measurement, free boiled water, free temperature measurement, free consultation and medication were carried out.

In the early days of opening up, some systems were not well implemented and there was a phenomenon of irregular work. After many rectifications, the system has been fully implemented and fully meets the requirements of GSP. With the guidance and help of leaders at all levels, our store is determined to conscientiously implement the "Quality Management Standards for Pharmaceutical Trading", constantly learn and improve, strengthen internal management, adhere to standards, standardize business practices with GSP, strengthen quality education for employees, improve enterprise management level and market competitiveness, and be a pharmacy that will reassure leaders and satisfy people.

Self-inspection report of pharmacy drugs 3

I. General situation of the enterprise

The enterprise was established in March 20 13, and it is an individual drug retail enterprise. Enterprises take GSP as the criterion to compile and improve the enterprise quality management system.

At present, the company has 4 employees, including 2 pharmacists, pharmacists 1 person, and pharmaceutical professionals account for 100% of the total number. The allocation of pharmaceutical technicians can meet the requirements of quality management in pharmaceutical enterprises.

Second, the personnel organization of GSP organization

The enterprise shall set the person in charge, purchasing, maintenance and warehouse keeper as XX; The quality director is XXX；; The quality manager and inspector are XXX；; The examiner is XXXX and the salesperson is XXX and XXX, which defines the quality responsibilities of full-time quality personnel.

Three. Personnel and training

In order to continuously improve the professional and technical quality of all employees, a study and training plan has been formulated, and all employees are regularly organized to study drug management laws and regulations and professional and technical knowledge, and the assessment is conducted once every six months, and training files are established.

Four. Facilities and equipment

According to the requirements of the new GSP, the enterprise is equipped with computers and software for managing the purchase, sale and storage of drugs that meet the relevant management requirements, and is equipped with temperature and humidity detection equipment in the business place. Now it is equipped with a thermometer and an air conditioner. And equipped with rat-proof, insect-proof and fire-proof equipment. The business premises are clean and bright, and the business shelves and counters are complete.

Five, drug procurement, acceptance management

According to the requirements of the Drug Administration Law, the Quality Management Standard for Pharmaceutical Trading and other relevant laws and regulations, the quality and legal qualification of purchased drugs were reviewed, and the GSP certificate of drugs, the Pharmaceutical Trading License (Wholesale) and a copy of the business license stamped with the official seal of the enterprise were obtained. The power of attorney shall specify the scope and duration of authorization; A copy of the ID card of the drug salesman; To purchase imported drugs, ask the supplier for a copy of the registration certificate of imported drugs and the inspection report of imported drugs, and affix the original seal of the supplier's quality management agency; Imported drugs should have Chinese instructions. The audit system shall be implemented for enterprises that declare for the first time and drugs that declare for the first time. The enterprise has established a drug purchase ledger to record the drug purchase truly and completely, so that the tickets, accounts and goods are consistent, and then input them into the computer according to relevant procedures to do all the basic work well.

Acceptance management: The acceptance personnel shall, according to the original vouchers and tax receipts, check and accept the purchased drugs in batches in strict accordance with relevant regulations, and record them. Mainly check whether the accepted drugs meet the corresponding appearance quality standards. (1) Whether the outer packaging is firm and dry; Whether the seal and seal are damaged; Does the outer package indicate the general name, specification, manufacturer, approval number, registered trademark, batch number and expiration date? Whether the specific storage and transportation marks meet the requirements of drug packaging. (2) Whether there is a product certificate for each inner package, whether the container is reasonable, whether there is any damage, whether the seal is tight, whether the packaging handwriting is clear, and the product name, specification and batch number shall not be omitted; Bottle labels should be affixed securely. (3) The generic name, ingredients, specifications, manufacturer's name, approval number, production batch number, production date and expiration date of the drug are clearly printed on the drug label instructions. Labels or instructions should also include indications or functional indications, usage and dosage, contraindications, adverse reactions, precautions and storage conditions. (4) The name, main components and registration number are indicated on the label of the imported drugs, and there is a manual in Chinese, accompanied by the registration certificate of the imported drugs, the approval number of the imported medicinal materials and the inspection report of the imported drugs, and a copy of the red seal of the supplier's quality management institution is affixed. Collect adverse drug reactions in time and report them to the drug supervision department immediately.

Six, drug storage, maintenance and display (retail) management.

At the beginning of our enterprise's establishment, we created a storage and exhibition environment in strict accordance with GSP requirements, and decorated the business area according to the latest standards of the Municipal Bureau to make the business place spacious and bright. Shopping is convenient and the signs are eye-catching. According to the business situation and GSP requirements, drugs are classified. According to the performance and nature of drugs, the warehouse is divided into areas to be inspected (yellow), mixed areas (green), unqualified areas (red) and returned areas (yellow), so that drugs and non-drugs, external drugs and internal drugs can be stored separately, which is convenient for operation and prevents errors and pollution incidents. Shelves, greenhouse thermometers, light-proof facilities (curtains) and rat-proof facilities (door seals) have been added to meet the requirements of "seven precautions" (dustproof, insect-proof, bird-proof, rat-proof, moisture-proof, mildew-proof and pollution-proof). Install lighting equipment that meets the lighting requirements. Air conditioners are installed in commercial areas to ensure proper air humidity and temperature. Manage according to the Management System of Drug Storage, Maintenance and Display of our store. For example, drugs and non-drugs are displayed separately, over-the-counter drugs and prescription drugs are displayed separately, and internal drugs and external drugs are displayed separately. Special preparations, including ephedra preparations, are displayed at the counter, and warning slogans are marked. The counter in the disassembly area is equipped with corresponding disassembly tools. In addition, measure the temperature and humidity of the business area and warehouse every morning and afternoon, and take timely measures to adjust if it does not meet the requirements; Check the maintenance of drugs in stock and display regularly every month, and record as required. These measures can ensure the storage quality of drugs.

Seven, sales and after-sales service

In order to provide consumers with reliable drugs and high-quality services, enterprises conduct business training and assessment for salespersons engaged in drug retail. Drug sales, for the drugs purchased by customers, after verification, give the drugs to customers, issue sales vouchers, and explain the methods and taboos of taking drugs to customers in detail; Express the service convention in the business place, announce the supervision telephone number, and set up a customer suggestion book. Solve customers' comments and complaints in time, take seriously the drug quality problems reflected by customers, record them in detail and deal with them in time.

Eight, computer software system

Computer system is a well-known large company in China. Relevant modules meet the application requirements of the new GSP, automatically remind the inventory every day, and urge the sales of products near the shelf life every month. Expired enterprises and expired drugs can automatically restrict related procurement, acceptance and sales activities, and hemp-containing preparations can automatically restrict sales with their registered names and ID cards.

Nine. self-check

Our pharmacy has set up a self-inspection team headed by XXX, with the quality director as the core, to conduct self-inspection and rectification on the implementation of GSP management in our store:

First, scientifically summarize and sort out relevant archival records; The second is to fill in the sales label instructions on the shelves; The third is to clean the storefront again; The fourth is to further check and standardize classified management. Through self-examination and self-correction activities, the management level of GSP has been further improved.

Through GSP self-inspection, we believe that the standard requirements have been initially met, and now we apply for certification. Welcome the leaders to check and guide.