What is the basic knowledge of drugs and the relevant content of GSP?

GSP is the quality control of the pharmaceutical business process.

1. In order to unify the standards, standardize the GSP certification inspection, and ensure the quality of the certification work, according to the "Pharmaceutical Business Quality Management Standards" (and the "Detailed Rules for the Implementation of Pharmaceutical Business Quality Management Standards", the GSP certification inspection and evaluation standards for drug retail enterprises are formulated.

2. There are a total of 109 GSP certification inspection items for pharmaceutical retail enterprises, including 34 key items (34 items with "*" before the clause and 75 general items.

3. During the on-site inspection, a comprehensive inspection should be carried out on the listed items and their covered contents, and a positive or negative assessment should be made item by item. All items that are incomplete or incomplete are called defective items; The failure of key items is a serious defect; The general item is not qualified as a general defect.

Answer]: The GSP implemented before 2012 was issued by the State Drug Administration at that time Decree No. 20 "Quality or Modulus Management Specifications for Drug Trading", which came into effect on July 1, 2000. The current GSP of Xiang Nationality in China was issued by the former Ministry of Health and came into force on June 1, 2013.

What is the main GSP of a drug? How to classify the standard word of Chinese medicine and drugs?

Hello, the GSP of drugs mainly refers to the "Good Management Standards for Pharmaceutical Operations", and the national drug standard word of drugs and drugs are classified as follows: Class I: chemical drugs, and the approval number format is:

Chinese medicine standard word h + 4 digit year number + 4 digit sequence number; The second category: traditional Chinese medicine, the format of the approval number is: national medicine quasi-word z + 4-digit year number + 4-digit sequence number; Category III:

For biological products, the format of the approval number is: Sinopharm quasi-word S + 4-digit year number + 4-digit sequence number; The fourth category: the format of the approved Wenlu number for the sub-packaging of imported drugs is:

The quasi-word of Chinese medicine J + 4-digit year number + 4-digit sequence number; The drug approval number issued by the State Drug Administration is valid for five years. If it is necessary to continue production or import after the expiration of the validity period, the applicant shall apply for re-registration six months before the expiration of the validity period. It refers to the process of drug circulation, which is formulated to ensure that the drug meets the quality standards for planned procurement, purchase acceptance, storage, sales and after-sales service.

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Answer]: GSP is the English abbreviation of good Supply Practice for Pharmaceutical Products, which refers to a series of management principles and requirements formulated to ensure that drugs meet quality standards in the whole process of drug business for planned procurement, acceptance inspection, storage and maintenance, outbound transportation, sales and sales of post-training services.

1) GSP clause is the target requirement: in order to meet the requirements put forward by GSP, each operating enterprise must formulate a series of standardized procedure documents according to the actual situation of the enterprise to ensure that the target is achieved.

2) GSP clause is the total quality management of the business process: the total quality management of the business process, that is, preventive management, must be strictly managed for all the key links that can cause changes in the quality of drugs, emphasizing the close combination of inspection and prevention of the business process, and taking prevention as the main means.

3) GSP emphasizes the legal responsibility of drug business and quality management: those engaged in drug business and drug business must perform approval procedures in accordance with the law and consciously accept the supervision of the drug regulatory department.

4) GSP will include the quality of business service work into the management scope: drug business is a special commodity management, which has high requirements for personnel and work quality. Business is service, and the quality of service work directly affects the quality of drug management.

5) GSP is time-sensitive: As a state-mandated regulation, GSP has a strong timeliness. It should be revised and improved according to the needs of national development, and different versions should be used in different periods, and only the current version has legal effect.

GSP is the abbreviation of good supply practice in English, which means good standards, is a set of management procedures to control all the factors that may cause quality accidents in the circulation of pharmaceutical commodities to prevent quality accidents, pharmaceutical commodities in the whole process of production, operation and sales, due to internal and external factors, quality problems may occur at any time, and strict measures must be taken in all these links to fundamentally ensure the quality of pharmaceutical commodities. Therefore, many countries have formulated a series of regulations to ensure the quality of drugs, the implementation of GLP in the laboratory stage, the implementation of GCP in the clinical stage of new drugs, and the implementation of GUP in the use of pharmaceutical products, GSP is a very important part of this series of controls.

GSP is the abbreviation of "Good Practice for Drug Operation", which was issued by Order No. 20 of the State Drug Administration in 2000 and implemented on July 1 of the same year.

The implementation of GSP certification for drug trading enterprises in accordance with the law is an important part of drug supervision and management, and the implementation of GSP certification for drug trading enterprises promotes the adjustment of the industrial structure of pharmaceutical trading enterprises, promotes the improvement of the management means of pharmaceutical trading enterprises and the standardization of market behavior, so as to achieve the purpose of rectifying and standardizing the order of the drug market and ensuring the safety and effectiveness of people's drug use.

According to the relevant document requirements of the State Drug Administration, GSP certification will be implemented in three stages before the end of 2004, and the drug business enterprises will pass the GSP certification within the time limit according to the regulations, and the enterprises that fail to pass the certification after the deadline will be punished in accordance with the Drug Administration Law. Until its business qualification is cancelled, the "Drug Business License" will not be renewed.

The quality management of pharmaceutical wholesale enterprises involves eight aspects:

1. Management responsibilities;

2. Personnel and training;

3. Facilities and equipment;

Fourth, the purchase; 5. Acceptance and inspection;

6. Storage and conservation;

7. Outbound and transportation;

8. There are a total of 132 sales and after-sales services, including 37 key items (i.e., one veto item) and 95 general items.

During the on-site inspection, all items and their covered contents are comprehensively inspected, and the members of the inspection team make affirmative or negative assessments one by one. The failure of key items is a serious defect; The general item is not qualified as a general defect. 1. Pass the GSP certification on-site inspection, there shall be no serious defects, and general defects shall not exceed 10.

GSP is the best product standard, which is a set of management procedures to control all the factors that may cause quality accidents in the circulation of pharmaceutical commodities to prevent quality accidents.

In the whole process of production, operation and sales of pharmaceutical products, due to internal and external factors, quality problems may occur at any time, and strict measures must be taken in all these links in order to fundamentally ensure the quality of pharmaceutical products. GSP is the English abbreviation of "Good Practice for Pharmaceutical Operation", which is a unified quality management standard for pharmaceutical trading enterprises. Pharmaceutical business enterprises shall meet the GSP requirements within the time specified by the drug regulatory department and obtain the certification certificate through certification.

GSP has separate chapters on the quality requirements of drug wholesale and drug retail in the document structure to facilitate practical implementation. In the past, GSP did not have separate requirements for drug wholesale and retail, which brought some conceptual ambiguity and operational inconvenience to the actual implementation.

The main content category of GSP is Inventory and Write-off.

Hardware facilities, acceptance sites and facilities, storage facilities, maintenance sites, business premises and facilities, laboratories, all kinds of testing instruments.

Personnel qualifications and responsibilities Planning, purchase personnel, storage, maintenance personnel, business, sales personnel, enterprise leaders, quality management, acceptance, inspection, laboratory personnel.

Quality management procedures system 1, planning, on-demand purchase, merit-based procurement. 2. The contract clarifies the quality terms 3 The quality audit of the first business variety manufacturer % is accepted according to the batch number 1, classified storage and custody 2, expiration date drug management 3, return management 4, nonconforming product management 5, color code management 1, planning, to ensure reasonable inventory. 2. Correctly publicize and introduce products 3. Delivery review 4. Do a good job in after-sales service.

Document Management System, Quality Acceptance Records, Maintenance Records, Sales Records, Quality Standards, Files, Laboratory Records.

GSP is a set of management procedures to control all possible quality accidents in the drug circulation process, so as to prevent quality accidents. In fact, it is a comprehensive, full-staff, whole-process management.

1. The basic requirements of GSP for pharmaceutical trading enterprises are: to establish a quality management system for pharmaceutical business and make it operate effectively.

2. GSP management documents are a series of normative documents formulated for the implementation of drug business quality management standards. Including: 1. Quality management system, quality management procedures, and quality management responsibilities; 2. In the process of enterprise operation and management, the detailed classified management and implementation documents, summary analysis, summary reports and other records around the contents specified in the system, procedures and responsibilities are recorded.

3. Covering hardware (facilities and equipment), software (system regulations and implementation documents).

equipment that meets the requirements of drug characteristics; It is the equipment you need to operate and store medicines. Like what; Do you have insulin or other biological products, drugs that need to be stored below 2-8 degrees or 20 degrees, if you deal in the above drugs, you must prepare a "refrigerator", the weather is hot in summer, the temperature of the medicine is required to be below 30 degrees, you must have an "air conditioner", otherwise how can you adjust the room temperature below 30 degrees? Also, you need to have an indoor "thermohygrometer" to record temperature and humidity.

There are also counters and shelves, and "rat traps" are also needed. If it is a wholesale enterprise, the door of the warehouse should also have a movable "rodent-proof board", "mosquito trap lamp" and so on.

The full English name of GSP is good Supplying Practice, which literally translates as good drug standards, and is called "Good Pharmaceutical Business Quality Management Practices" in China.

It refers to a management system formulated to ensure that drugs meet quality standards in the process of drug circulation, such as planned procurement, purchase acceptance, storage, sales and after-sales service. Its core is to restrain the behavior of enterprises through a strict management system, carry out quality control of the whole process of drug operation, and ensure that high-quality drugs are provided to users.