Xx pharmacy was established on 200x, xx month, xx day. Is an individual retail enterprise, and its business scope includes: Chinese herbal pieces, Chinese patent medicines, chemical preparations, antibiotics, biochemical products and biological products. The store address is xx Town, the business place is xx square meters, the warehouse area is xx square meters (both are cold storage), and the effective volume of refrigerator is 189l. Since its opening, its sales amount is nearly X million yuan and its gross profit is xx yuan. There are nearly xxx kinds of drugs, all of which meet the requirements of laws and regulations stipulated by the state, and no counterfeit and inferior drugs have been distributed since its opening. Pharmacies adhere to the business tenet of "sincerely attracting customers, reputation first" and take gsp as the quality standard of enterprises. As soon as the pharmacy opened, it consciously carried out business activities in accordance with the requirements of gsp certification and strived to standardize quality management. Especially since the beginning of this year, we have carefully studied drug laws and regulations, gsp and its implementation rules, compared with gsp certification standards item by item, and made repeated self-examination and rectification, which has achieved remarkable results and substantially improved the quality management level of pharmacies. Our store believes that it has basically reached the requirements of gsp certification standards at present. The implementation of gsp certification in our store is now reported as follows:

I. Institutional setup and staffing

The implementation of gsp involves the procurement, storage, sales and after-sales service of drugs, which is the management of all staff and the whole process. In order to ensure the smooth implementation of gsp certification, the person in charge of the enterprise is responsible for the organization and coordination of gsp certification, and at the same time, it is equipped with the person in charge of enterprise quality to be responsible for the quality management of the enterprise and organize the implementation of gsp certification. The company has X employees, X pharmaceutical technicians (pharmacists), and the quality supervisor is a pharmacist, who is specifically responsible for the implementation of the company's quality management system and business management, as well as the management and review of retail prescriptions to ensure the quality of drugs and services. All employees have received professional training according to the post requirements. In addition, pharmacies regularly organize employees to participate in health checkups every year, and establish health records for each employee to ensure that employees who pass the health checkup have direct contact with drugs. At present, the pharmacy staff is reasonable and meets the requirements of gsp certification.

Second, pay attention to publicity, education and training.

In order to successfully implement gsp certification and improve employees' professional quality and quality awareness, a training plan has been formulated, and relevant personnel have been organized to participate in post technical training, marketing technical training and gsp special study by combining internal and external training. The gsp study covers the laws and regulations related to drug business, the knowledge of drug quality management, and the quality management system, working procedures and quality responsibilities formulated by pharmacies. Through study and training, the professional quality and job skills of employees have been greatly improved, and employees also realize that gsp is a criterion that must be followed in drug business activities, ensuring the smooth implementation and implementation of gsp certification.

Third, improve the quality management system.

According to the requirements of the Drug Administration Law, the Quality Management Standard for Pharmaceutical Trading, and the gsp Certification Inspection and Evaluation Standard for Pharmaceutical Retail Enterprises, combined with the actual situation of the enterprise, the person in charge of pharmacy quality organized relevant personnel to formulate the Pharmacy Quality Management System, the Quality Responsibilities of Personnel at All Levels and the Drug Quality Control Procedure, so that each employee made clear the quality management regulations for each post and made the work rule-based. According to the regulations of the system, the quality director group of pharmacy will assess the implementation of various systems every six months, and immediately rectify and correct the problems when they are found.

Fourth, increase investment in hardware and improve facilities and equipment.

In order to effectively implement gsp certification and improve drug management and storage conditions, our store has purchased refrigerators, air conditioners, exhaust fans and other temperature and humidity control ventilation equipment suitable for the business scale; At the same time, shelves are equipped, and rat-proof equipment is added to make the warehouse meet the requirements of dust-proof, moisture-proof, pollution-proof, insect-proof, rat-proof and mildew-proof, and there are fire safety equipment inside the reservoir area. At the same time, the pharmacy manages the warehouse in different areas, and the color code is obvious, which makes the division of the four areas of the warehouse meet the requirements of gsp.

Five, strictly control, strengthen the quality management of procurement, storage and sales.

In order to ensure effective quality management, pharmacies conduct comprehensive and systematic management of drug procurement, storage and sales, and track the whole process. At the same time, pharmacies have detailed and true records of the management of the whole business process, ensuring that the drug purchase channels are legal, the drug quality is qualified, and the management tracking is in place, effectively preventing the occurrence of various quality accidents. Since the pharmacy opened, there has been no distribution of counterfeit and inferior drugs, and there have been no adverse reactions and customer complaints related to drug quality.

Six, pharmacies in the process of drug procurement, storage, sales and after-sales service, specifically to do the following.

1. The purchase of drugs should be carried out in strict accordance with the quality management system of the pharmacy, and the audit of the supplier's quality assurance system should be strengthened. Require suppliers to provide copies of the Drug Business License and Business License with official seals, establish supplier files, strengthen the qualification review of drug sales personnel of suppliers, and sign quality assurance agreements with suppliers; When purchasing imported drugs, suppliers are required to provide a copy of the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products and the Inspection Report of Imported Drugs stamped with the original seal of the supplier's quality management organization, so as to ensure good quality from the source.

2. Drug acceptance.

Inspectors strictly inspect the appearance, shape, packaging and label of drugs according to the corresponding laws and regulations, contract quality terms and new quality standards, and resolutely reject those that do not meet the requirements.

3, standardize the management of drug display

In accordance with the requirements of gsp, pharmacies standardize the management of drug display, so as to place drugs according to their purposes. At the same time, drugs are stored separately from non-drugs, drugs for internal use and external use, and drugs that are easy to smell, and prescription drugs and over-the-counter drugs are stored in separate cabinets, with obvious and clear labels. Check the drugs on display every month and record them truthfully.

4. Pay attention to the maintenance of drugs.

According to the quality management system of pharmacies, maintenance workers store and display drugs reasonably according to the storage conditions of drugs, record the temperature and humidity of warehouses and business places on time every morning and afternoon, and take timely control measures when the temperature and humidity do not meet the requirements of drug storage. At the same time, the general drugs in stock are inspected quarterly, and the key maintenance varieties are inspected monthly. The maintenance files of key maintenance varieties have also been established, and the maintenance records are true, perfect and standardized.

5. Do a good job in drug sales.

In order to standardize the behavior of the drug trading industry and provide consumers with safe drugs and quality services, prescription drugs are audited by prescription, and other drug salesmen can insist on asking questions, that is, the "three questions" about illness, gender and age, that is, explaining the administration method, dosage and precautions. After checking the name, specification, quantity and price of the drugs purchased by customers, hand in the prize drugs. At the same time, pharmacies express the service convention in their stores, announce the supervision telephone number, and set up a customer suggestion book; And provide consulting services to guide customers to use drugs safely and reasonably.

Article 2 GSP Internal Audit and Self-inspection Report

According to the requirements of the Drug Administration Law of People's Republic of China (PRC), the new version of the Quality Management Standard for Pharmaceutical Trading and the Detailed Rules for the Implementation of the Quality Management Standard for Pharmaceutical Trading, the pharmacy in our hospital attached great importance to the implementation of GSP, and made careful preparations and comprehensive inspections. Now we report the implementation of GSP certification and self-examination in pharmacies in our hospital as follows: 1. Enterprise profile.

Our store was established in 20xx1October 20th, 165438+2 1. Located at Tianyuan New Village/Building KLOC-0/7 12, Wu Aizhi, the person in charge of the enterprise, and Wu Aizhi, the person in charge of quality. Business scope: prescription drugs and over-the-counter drugs, Chinese patent medicines, chemical preparations, antibiotic preparations, biochemical drugs, Class B over-the-counter drugs, etc. At present, there are 4 employees, including pharmacists 1 person, and 3 of them have obtained employment certificates, with a business area of 106 square meters. There are more than 800 kinds of business.

Second, the quality management and system

Due to the small size of our store, few staff and less business, we only set up a quality management team consisting of four people: the pharmacy legal person, the person in charge of quality management, Wu Aizhi (also a resident pharmacist), the inspector Shen and the maintenance worker. At the beginning of its opening, our pharmacy formulated a set of quality management documents suitable for its own actual situation according to the requirements of GSP. In the course of operation, our pharmacy strictly follows GSP requirements. In the early stage of starting a business, 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 the new GSP.

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 Chinese manual, with 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

When our enterprise was established, we strictly followed GSP requirements, created a storage and display environment with high standards, and decorated the business area according to the 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.

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, the drugs will be handed over to customers, and sales vouchers will be issued, and at the same time, the medication methods and taboos will be explained 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

The computer system was developed by Shenzhen Wanguo Sixun Software Co., Ltd., a famous domestic company. 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 manager Yanwu and with 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.

Article 3 GSP Internal Audit Self-inspection Report

I. Quality management institutions and systems With the gradual expansion of the company's business scale and scope, our company constantly adjusts and improves the company's quality system, enriches the quality management institutions and personnel, clarifies the responsibilities of various departments and personnel, formulates the quality management policies and objectives of the enterprise, prepares quality management program documents and operating procedures, and conducts regular inspections and assessments, so as to ensure that the company's quality management personnel exercise their functions and powers and equip quality management institutions and personnel more scientifically and reasonably; According to the relevant provisions and requirements of GSP, gradually revise and review various quality management systems, quality work procedures, institutions and post responsibilities, so as to make the company's quality management work evidence-based and rule-based, improve the company's quality management system documents and effectively implement various quality management systems and work procedures.

The enterprise has set up an independent quality management department and a full-time inspection and maintenance team. The quality control department consists of a quality management group and a quality acceptance group, which can implement relevant drug laws and regulations and company quality management documents. Quality management departments exercise quality management functions in all aspects of enterprise operation and have the right to make decisions on drug quality within enterprises.

The enterprise has formulated the internal audit system of quality management system, and regularly conducts internal audit on GSP operation to ensure the normal operation of the quality system.

Second, personnel training.

In order to improve the comprehensive quality of all employees, our company not only actively participated in various trainings organized by provinces and cities, but also held a series of internal trainings. These include laws and regulations training, company system, work flow, responsibility system training, skills training in various positions, drug classification knowledge training and employee moral education. All trainings have been assessed, and training files and assessment files have been established, which has achieved obvious training results.

Business leaders also attach great importance to the study of relevant national drug laws and regulations and drug management knowledge, and organize regular study and training. The person in charge of the enterprise and the person in charge of quality have both graduated from university, and the quality management personnel such as the deputy general manager in charge of quality and the manager of quality control department are licensed pharmacists with bachelor degree or above, with rich practical experience and management ability. Personnel engaged in quality acceptance, maintenance and sales all have college education or above.

According to GSP's requirements for all kinds of personnel, the company conducts health examination for employees who are in direct contact with drugs, and holds relevant certificates after passing the examination, and establishes health files, which are strictly implemented in accordance with relevant rules and regulations.

Third, facilities and equipment.

Our business office area is * * * square meters, which can meet the daily business office needs. The office space is bright and tidy, with reasonable layout, equipped with necessary modern office equipment, and computerized management of purchase, sale and storage.

The warehouse covers an area of * * * square meters, including * * square meters of cold storage, * * square meters of cold storage, * * square meters of Chinese herbal medicines and Chinese herbal pieces storage and * * square meters of medical equipment storage, which can meet the requirements of our company for drug storage. The warehouse layout is reasonable, the ground is flat, the doors and windows are tight, there is no pollution source, and it is dustproof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rat-proof and bird-proof, and the equipment and facilities and fire safety facilities meet the requirements. The area to be inspected, the qualified product area, the unqualified product area, the return area and the delivery area are subject to color code management, and the qualified product area is effectively isolated from the unqualified product area and the return area, and the warehousing operation area, the auxiliary operation area and the office living area are effectively isolated. Each warehouse has complete temperature and humidity monitoring equipment, which can meet the requirements of the company's drugs stored in different warehouses and under different storage conditions according to their physical and chemical properties.

The acceptance curing room is * * * square meters, equipped with11000 balance, purity detector, moisture meter, ultraviolet fluorescent lamp, standard colorimetric solution, microscope, specimen room, zero cargo area and special equipment for drying, oxygen reduction, fumigation and curing. Establish equipment files and use and maintenance files for various acceptance and maintenance instruments and equipment.

Fourth, procurement management

Drug procurement management is the first-level quality control of drug management, and it is also the key link to ensure the legitimacy of enterprise management behavior and the quality of drug management. Our company adheres to the principle of quality as the premise and purchasing on demand, and implements unified drug management. The purchasing department organizes purchasing, and the business departments sell them separately. The purchasing department shall make a purchasing plan every month, which shall be attended by relevant personnel of the quality control department and submitted to the competent leader for approval before filing.

Strictly control the quality of drug procurement, seriously implement the approval system and procedures of the first battalion enterprise and the first battalion variety, the drug procurement system and procedures, pay attention to the inspection of the supplier quality assurance system, ensure the legitimacy of all suppliers and purchased drugs, 100% sign a drug quality assurance agreement with suppliers, and establish a file of qualified suppliers.

Verb (abbreviation of verb) acceptance management

The quality management department of our company is responsible for the quality acceptance of purchased and returned drugs. The quality control department has set up a special acceptance team, and the inspectors are in the maintenance room in strict accordance with the relevant systems and procedures for quality acceptance.

According to legal standards and purchase contracts, inspectors inspect the quality of purchased drugs batch by batch according to the specified proportion, conduct appearance inspection on the varieties, injections and various dosage forms purchased for the first time, and resolutely refuse to guarantee unqualified drugs and counterfeit drugs, and the qualified rate of drugs in storage is 100%. Imported drugs have the registration certificate of imported drugs and the inspection report of imported drugs stamped with the original seal of the supplier's quality management agency. External drugs and OTC drugs shall be identified and accepted according to regulations.

Drug acceptance record is the core basis of enterprise quality acceptance. All drugs that pass the acceptance must fill in the quality acceptance record in detail. The contents of the records shall be true and complete, and the acceptance conclusion shall be signed by relevant personnel. Acceptance records shall be kept as required.

VI. Storage and Maintenance

In terms of drug storage, our company will store drugs in strict accordance with the storage requirements. Firstly, according to the required storage conditions, the drugs are stored in the normal temperature warehouse, the cold storage warehouse and the cold storage warehouse respectively. Secondly, according to their natural properties, drugs for internal use and external use are stored separately, and drugs that smell easily are stored in non-drug special warehouses. Drug reports near the expiration date shall be filled out at the specified time every month.

Do a good job in drug maintenance. According to the drug classification regulations, the stored drugs will be identified as key maintenance varieties, and key maintenance plans will be formulated, and cyclic maintenance will be carried out every month. Establish drug storage records and files, and store and keep drugs in the warehouse in strict accordance with their physical and chemical properties and storage conditions to ensure the good quality of drugs in the warehouse; Record the temperature and humidity every day, adjust the temperature and humidity of the warehouse in time, and report the problems in time.

For the returned drugs sold by the company, they shall be handled according to the relevant operating procedures. The keeper receives the goods with the return certificate issued by the sales department and stores them in the return area. After the inspector passes the inspection, put it into the qualified product warehouse. Unqualified drugs should be stored in unqualified areas. The confirmation, reporting, loss reporting and destruction of unqualified drugs shall be carried out in accordance with the prescribed procedures, and a sound record file shall be established.

Seven, outbound and transportation

Drug delivery should strictly implement the principle of delivery by batch number, strictly implement the delivery review system, and review the drugs item by item. If there are any quality doubts in the review, the delivery should be stopped immediately and reported to the Quality Control Department for handling, so as to ensure that the unqualified drugs do not leave the warehouse; According to the physical and chemical properties and transportation conditions of drugs, necessary cold storage, heat preservation equipment and transportation safety facilities are equipped to ensure the quality of drugs in transit.

Eight, sales and after-sales service

In order to strengthen the sales and service of drugs, storekeepers and reviewers carefully count the number of drugs and check the quality of drugs. The sales department carries out sales activities in strict accordance with relevant laws and regulations and the enterprise quality management system to ensure that drugs are sold to legally qualified units. Insist on operating in accordance with the law, and do not have business relations with units that are not qualified to operate and use drugs, so that all drug sales have legal bills and establish complete sales records.

Ensure service quality, implement quality inquiry system and provide after-sales service. The company advocates enthusiastic service and establishes customer complaint records and files for follow-up. The company regularly inquires about the drug quality of customers and suppliers, timely transmits and summarizes drug quality information, and establishes drug quality inquiry records and quality information transmission feedback records. Follow up and monitor the occurrence of adverse drug reactions, report them in time, and recover drugs in time to ensure the safety and effectiveness of drugs.