gsp self-examination report
First, the company's profile
1, the nature and type of business:
XXXX Pharmaceuticals Co. XXXX Pharmaceutical Company", the company was founded in 1992, formerly under the XXXXXXXXXX. business address is the city of XXXXXXXXXX. The company under the leadership of the general manager, in strict accordance with the requirements of the GSP standardized business practices, the company from the purchase of drugs, storage, sales have been in accordance with the GSP requirements of the management, the implementation of quality management responsibilities and quality management procedures, through continuous training so that employees know what to do in their positions, how to do, the responsibility of the implementation of the person.
2, business premises, warehouses, office and auxiliary area:
The company's existing office space area of 300 square meters, business premises area of 90 square meters, storage area of 1,232 square meters, of which the cool warehouse: 982 square meters, room temperature warehouse 214 square meters, refrigerated warehouse 14m2, easy to crosstalk library 22 square meters. There is also a 40m2 acceptance of the conservation room.
Warehouse according to the requirements of the division into: pending inspection area, return area, shipping area, qualified products area, non-qualified products area, respectively, with yellow, green, red obvious signs. The administrative office is completely separate from the warehouse.
3, personnel profile:
The company's existing staff of 80 people, of which: 1 licensed pharmacist, 2 pharmacist practitioners, drug 1 teacher, other technical personnel 4 people. Pharmacy technicians accounted for 10% of the total number of employees. Engaged in drug quality management, acceptance, maintenance staff 7 people.
The main person in charge of the company has the relevant academic qualifications and titles, and is familiar with the national laws, rules and regulations on drug management and the knowledge of the drugs operated. The manager of the quality control department has the qualification of licensed pharmacist and college degree. Personnel engaged in quality management are all college educated and full-time on duty.
4, the enterprise business situation:
(1) the scope of the mode of operation: the scope of business: proprietary Chinese medicines, chemical preparations, antibiotic preparations, biochemical drugs, biological products.
(2) The company's registered capital of 1 million yuan, more than 660 kinds of business products in 20XX, 20XX completed sales of about 80 million yuan.
Second, the company's GSP quality system internal review
In order to implement the "Drug Administration Quality Management Standard" and its implementation rules, the company has established a general manager as the head of the General Manager, including the quality control department, the Office of the Department of Business, Storage and Transportation Department, Department of Finance, responsible for the management team of the GSP, the members are. XXXXXXXXXXX and so on, and clarified the specific functions. At the same time, software organization and hardware transformation were carried out. In order to make our company's quality management in line with the certification standards, we conducted a comprehensive internal review on January 12, 20XX - January 14, 20XX. Through the development of the program, held a meeting to set up the task, put forward requirements, organization and inspection, comprehensive review, issued a notice of rectification, the development of measures, the implementation of rectification, and finally make the enterprise self-examination internal audit report.
The specific content is as follows:
1. Established a quality management organization, developed a quality management system, issued a quality policy objectives.
(1) quality management organization
The establishment of a quality management organization under the direct leadership of the general manager. The organization set up under the quality management group, quality acceptance and maintenance group. The person in charge of the enterprise quality management organization is a licensed pharmacist; quality control, acceptance, maintenance and sales personnel have secondary school education, by the Drug Administration training and examination. Engaged in quality control, acceptance, maintenance staff 7 people, accounting for 9% of the total number of employees.
(2) The formulation and operation of quality documents for drug business:
The company has formulated a quality policy and objectives, which has become the basic guideline for the company to carry out quality management and various quality activities.
The general manager and the person in charge of the quality management organization led the organization to prepare the quality management responsibilities, procedural documents, standardize the relevant records, and clearly regulate the responsibilities of various departments and job accountability.
Procedural documents include: quality policy and target management; quality system audit; quality responsibility; quality veto; quality information management; first enterprise and first varieties of the audit; quality acceptance; warehousing, storage, maintenance and out of the warehouse review of the management; records and vouchers management; expiration date of the drug, unqualified drugs and return of the management of the drug; quality accidents, quality inquiries and quality complaints management. Provisions on adverse drug reaction reporting; management of hygiene and personnel health status; education, training and assessment provisions on quality, etc. In 20XX, according to the changes of internal and external environments, we revised and promulgated the quality management documents, of which 16 quality duties, 36 quality management systems and 21 operation procedures were revised and promulgated. These include: the management of Xingx agent drugs, such as the zoning management of Xingx agents, acceptance, as well as the request for auditing the qualifications of sales customers and personnel. Through continuous improvement of the quality management system, thus ensuring further standardization of the company's operations. In 20XX, our quality policy is "Quality First, Customer First", and our quality objectives are: 1. Ensure the standardization and legality of the company's business behavior; 2. Ensure the safety and efficacy of the quality of the medicines we deal with; 3. Ensure the effective operation of the quality management system and its continuous improvement; 4. Continuously improve the company's quality reputation; 5. Maximize customer satisfaction. At the same time, it is broken down as follows: 1. 100% approval rate of the first enterprise and the first variety; 2. 100% qualification rate of the stock of drugs; 3. Quality clauses in purchase and sales contracts or 100% signed quality assurance agreement; 4. Annual physical examination of the employees who are in direct contact with the drugs and the establishment of a health file; 5. Relevant positions are licensed; 6. Pre-service training of the newly recruited employees; 7. Acceptance of the incoming drug inspection and acceptance of the rate of 100%; 8. Quality inquiries and complaints received and handled 100%; 9. Quality information, adverse reactions reported in a timely manner 100%; 10. 0 major accidents throughout the year; 11. Quality training once a quarter. Through the development and release of the quality policy and objectives, a strong . Promote the company's quality management to carry out comprehensively, received good results.
(3) the implementation and operation of the quality system
The company regularly conducts quality management program implementation assessment, so that the management program is implemented in practice, and found that problems are corrected in a timely manner. Annual review and summary of the company's drug purchase quality.
2, personnel and training
(1) training: the company in order to improve the quality of personnel, to take the invitation to come in or send out of a variety of ways to personnel for continuing education. Actively participate in all levels of the Drug Administration's various training, quality control, acceptance, maintenance, custody and other relevant personnel have been trained and passed the examination. Company office and quality control department **** with the development of annual training plan, organized by the office according to the plan training, quarterly training and assessment. The content of the training includes laws, regulations, rules and drug management and drug expertise and professional technology, management procedures and management responsibilities, training and assessment are recorded and archived. Through training, the staff to improve the quality awareness, to ensure the effective operation of the quality management system. 20XX our company **** training 4 times, 10 hours, 4 times the assessment, are excellent, good.
(2) health checks: quality management, acceptance, maintenance, custody and other positions not only in the professional quality of personnel must meet the requirements, health status must also meet the requirements. New personnel shall be qualified by physical examination before taking up the post, in the post of personnel in accordance with the provisions of the annual physical examination. The above personnel have not suffered from skin diseases, infectious diseases or mental illnesses through medical examination. The office has established a "health check summary table" and health records.
3, facilities and equipment
The quality of the environment is to ensure that the drugs in the operation of its safe and effective basis. The company's existing office area of 300 square meters, 90 square meters of business area, storage area of 1232 square meters, including cool storage: 982 square meters, room temperature storage 214 square meters, refrigerated storage 14m2, easy to crosstalk library 22 square meters. There is also a 40m2 acceptance of the conservation room.
The ground in the warehouse area is smooth, no water and no source of pollution, and the office area is strictly separated from the storage area. The warehouse walls, roof, ground clean and smooth, doors and windows tight structure, and have a good ventilation system and drainage facilities. The storage area is equipped with temperature and humidity adjustment system, fire-fighting system and temperature and humidity meter. The cold storage warehouse is equipped with double power supply, and temperature and humidity automatic recording equipment is installed. When the temperature and humidity of the warehouse is out of range, timely regulatory measures are taken in order to keep the qualified range. In addition, the warehouse area is set up with ventilation, rodent repellent, pest control, anti-mosquito and other facilities, as well as in line with the safety of the lighting facilities and demolition of zero, consolidation of boxes and other workplaces.
Acceptance of the maintenance room is equipped with: one-thousandth of the balance, standard colorimetric liquid, clarity detector, air conditioning, indoor temperature is strictly in accordance with the requirements of regulation.
The company's equipment and facilities used in the development of inspection, repair, maintenance and operating procedures and the establishment of the use of records and files.
The business hall is spacious and bright, with 8 computers, and all the purchase and sale operations are managed by microcomputers.
4, the purchase of drugs
The company strictly in accordance with the development of the "Drug Purchase Procedures", "Drug Purchase and Sales Contract Review Procedures", "the first enterprise and the first varieties of the audit system" on the supplier to carry out audits, the establishment of the supply enterprise files. In order to ensure that the purchased drugs are legal enterprises to produce or operate, in line with the quality requirements of qualified drugs.
In the audit to determine the supplier enterprise at the same time, its sales staff in contact with the enterprise to confirm the legal qualifications. That is: to collect copies of the ID card of the sales staff, check the power of attorney of the legal person it holds and the duration of the power of attorney.
The purchase contract signed between the company and the supplier company has a quality clause and is implemented according to the quality clause. Purchase and sales contracts are clear: the quality of drugs should be in line with its quality standards and relevant quality requirements; drugs with product certification; drug packaging in line with the relevant provisions and requirements for the transportation of goods. The Operations Department has established a contract management account. The Quality Management Department is responsible for monitoring the implementation of the quality provisions in the purchase contract.
At present, we have completed the approval of the first 580 enterprises and the approval of the first 387 varieties. Now the supplier is fully qualified, quality qualified, bills are complete.
5, drug acceptance
The company is in accordance with the national legal standards and the quality terms of the purchase contract, as well as the "Drug Acceptance Management System", "Returned Drugs Management System", "Drug Quality Acceptance Procedures" for the quality of purchased medicines, the return of medicines batch by batch acceptance, including the appearance of the drug traits checking and drugs, internal and external packaging and labeling inspection. The quality of the purchased drugs and drugs returned after sale is inspected batch by batch, including the inspection of the appearance of the drugs and the inspection of the internal and external packaging and labeling of the drugs. The acceptance inspection record records the supplier, quantity, date of arrival, name, specification, approval number, manufacturer, expiration date, quality status, acceptance conclusion and acceptance personnel. Acceptance records are archived as required.
The sale of returned medicines, the acceptance of personnel in accordance with the provisions of the incoming "acceptance rules" batch by batch acceptance. And fill out the "post-sale return of drugs inspection and acceptance records", the records are required to file.
Acceptance is completed within the specified time limit, acceptance sampling according to the "acceptance sampling rules" for sampling to ensure that the samples taken are representative. The first camp varieties must have the batch number of the quality inspection report of the drug. Warehouse custodian receives the goods with the signature of the inspector. If the goods do not conform to the list, the quality is abnormal, the package is not secure or broken, the sign is blurred, etc., refuse to accept and report to the relevant departments to deal with.
For drug acceptance and maintenance of instruments, measuring instruments, according to the provisions of the registration, use and periodic calibration and records.
The discovery of unqualified drugs according to the "Unqualified Drugs Management System" reported by the confirmed unqualified drugs, moved to the unqualified goods area storage, and hanging red unqualified goods signboard.
Unqualified drugs in accordance with the "Unqualified Drugs Management System", "Sales Drugs Management System" to confirm, report, report loss, destruction and fill out the appropriate records.
08 years after the restructuring has been accepted 1493 batches of drugs, acceptance rate of 100%, acceptance rate of 100%, are recorded.
6, drug storage and maintenance
(1) the strict implementation of color-coded and "separate" management. The warehouse is divided into the area to be examined, qualified products area, non-qualified products area, returned drugs area, shipping area, and color-coded marking. The caretakers and storekeepers arrange the drugs strictly according to the requirements. To do drugs and non-drugs separate; internal drugs and external drugs separate; easy to flavor drugs and general drugs separate. And to achieve the "five distance" requirements.
(2) strict control of temperature and humidity in the warehouse. Conservation staff at any time to check the storage conditions of the drugs in the library. Cooperate with the custodian of the warehouse temperature, humidity monitoring and management. Daily morning and afternoon each time regularly on the warehouse temperature, humidity records. If the temperature and humidity of the warehouse exceeds the prescribed range, take control measures.
(3) Conservator of the warehouse drugs according to the flow of regular maintenance and inspection, and make a good record of maintenance, the establishment of the drug conservation file. Drug care staff should regularly summarize, analyze and report the quality information of the maintenance inspection, near expiration date or long time storage of drugs.
(4) Effective date drug management. The company developed the "drug expiration date management program", the custodian of the termination of less than 6 months from the expiration date of the drugs, immediately fill out the "near-expiry date drug sales call sheet", wall management and sales call. When reviewing the inventory, expired drugs are strictly prohibited from leaving the warehouse.
(5) Unqualified drug management. The company has formulated the "Unqualified Drugs Management System", which makes clear provisions for the determination, storage, reporting and destruction of unqualified drugs.
(6) Returned drugs management. The company has formulated the "Returned Drugs Management System", which makes provisions for the management of purchased and withdrawn, sold and returned drugs.
7, out of the warehouse, review and transportation
Drugs out of the warehouse for review and quality inspection. Drugs out of the warehouse, the reviewer according to the inventory list on the physical quality inspection and quantity, project verification, especially to achieve the drugs out of the "first production first sale" "first in first out" "easy to change out first In particular, it is necessary to achieve the "first production first sale", "first in first out", "perishable first out", "recent first out" and shipment according to the lot number. Drugs out of the warehouse, there are the following problems to stop the delivery, and reported to the caretaker to deal with: abnormal ringing and liquid leakage in the drug package; the outer packaging is broken, sealing is not secure, the liner is not solid, the seal is seriously damaged and other phenomena; the packaging marking fuzzy or fall off; the drug has exceeded the expiration date.
For each batch of drugs out of the warehouse reviewer must fill out the review record. Review records include: purchasing unit, product name, dosage form, specifications, batch number, expiration date, manufacturer, quantity, date of sale, quality, acceptance and review of the conclusion of the project. Review records are kept as required.
For the transportation of medicines with temperature requirements, the caretaker takes the necessary heat preservation or refrigeration measures according to the season and transportation. When handling and loading and unloading of drugs, strictly according to the outer packaging illustrated signs light take, light put and stacking, and for the packaging conditions of the drugs as well as the road conditions, to take appropriate protective measures to prevent confusion and damage to the drugs.
8, sales and after-sales service
The company strictly control the sales channels of drugs, to ensure that the drugs are sold to units with legal qualifications. Our company has insisted on obtaining the customer's valid "drug business license", "medical institutions practice permit", "business license" and establish a file. At present, more than 1400 customer files have been established, and the salesmen issue legal bills to match the bills, accounts and goods. The company establishes drug sales records in accordance with the regulations, recording the drug name, dosage form, specifications, batch number, manufacturer, purchasing unit, sales quantity, sales date and other items. Sales records are kept as required.
The company promptly identifies the causes of quality inquiries, complaints, sampling and quality problems found in the sales process, assigns responsibility, takes effective measures to deal with them, and keeps good records.
The company has formulated the "System of Adverse Drug Reaction Reporting", paying attention to the collection of adverse reactions to the drugs sold by the enterprise, and the discovery of adverse reactions will be reported to the competent authorities by the Quality Management Department in accordance with the regulations. There has been no such incident yet.
Third, the conclusion of the internal review
Through the internal review that our company in the implementation of the quality management system, continuous improvement in the quality management system, personnel and training, equipment and facilities, drug purchase, drug acceptance, storage and maintenance, out of the warehouse review and transportation, sales and after-sales service and so on, compared with the past has made significant progress, basically in line with the GSP certification. The company has made significant progress and basically meets the requirements for GSP certification, so it is applying for certification.