What are the main checks of the new version of GSP certification standards

There are the following five items: 1. Check the file 2, check the operation, drug display environment 3, check the file 4, check the storage and import of drugs Pharmacies implement the classification management measures for drugs 5, check all kinds of records and **.

1. Introduction: GSP is the abbreviation of goods supplying practice in English, which literally translates as the specification of goods.

2. In China, it is called "Good Practice for Pharmaceutical Operations".

3. 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.

4. Its core is to restrain the behavior of the enterprise 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.

Summary. Hello dear, GSP compliance includes; GSP certification content: The on-site inspection of the pharmacy is the key part of the inspection. In the certification standards, there are a total of 54 inspection items for pharmacies, including 19 key items, and the inspection content is mainly focused on the business scope and business form of the pharmacy, whether it meets the requirements of the regulations, the corresponding staffing, the setting of software and hardware facilities, and the degree of standardization and standardization of the operation are strictly and detailed inspections.

When conducting on-site inspections, a brief on-site meeting will be held in the pharmacy by the designated certifier on the sampling requirements and content of the pharmacy, mainly for some inspection procedures.

Hello dear, GSP compliance includes; GSP certification content: The on-site inspection of the pharmacy is the key part of the inspection. In the certification standards, there are a total of 54 inspection items for pharmacies, including 19 key items, and the inspection content is mainly focused on the business scope and business form of the pharmacy, whether it meets the requirements of the regulations, the corresponding staffing, the setting of hardware facilities for soft round eggplant, and the degree of standardization and standardization of the operation. When conducting on-site inspections, a brief on-site meeting will be held in the pharmacy by the designated certifier on the sampling requirements and content of the pharmacy, mainly for some inspection procedures.

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Hello, dear: GSP (Good Management Practice for Pharmaceutical Operations) is a quality management standard that must be complied with by pharmaceutical business enterprises in China, and the requirements of the new version of GSP for calibration and verification mainly include the following points: 1

Calibration and verification should comply with the requirements of national laws and regulations and relevant standards, such as "Good Practice for Drug Operation", "Drug Administration Law", etc. 2.Calibration and verification should be carried out by an appropriately qualified institution or person and should be carried out on a regular basis.

3.Calibration and verification should be recorded and kept for at least two years. 4.

Calibration and verification should include the detection of the accuracy, accuracy, sensitivity, linearity, repeatability and other indicators of the equipment. 5.Calibration and verification should analyze and evaluate the test results and take corresponding measures to correct and improve.

6.Calibration and verification should be carried out on the basis of equipment maintenance and maintenance to ensure the normal operation and accuracy of the equipment. Extended Supplements:

In addition to the above points, the new Hanling version of the GSP also put forward higher requirements for the quality management system of pharmaceutical business enterprises, including the establishment of a sound quality management system, strengthening drug procurement and chain management, standardizing drug storage and transportation, and strengthening drug quality control. Pharmaceutical trading enterprises should formulate corresponding quality management plans and measures according to their own conditions to ensure the quality and safety of drugs. At the same time, the regulatory authorities will also strengthen the supervision and inspection of drug trading enterprises, and crack down on violations.

What are the requirements for calibration and verification in the new version of GSP? For you to find out: GSP is the abbreviation of drug management quality management standards, and it is the quality management standard that drug business enterprises in China must comply with.

GSP's requirements for the calibration and verification of pharmaceutical business enterprises mainly include the following points:1Calibration and verification must comply with relevant national and local regulations and standards, and should be carried out regularly.

2.Calibration and verification should be carried out by a qualified unit or individual. 3.

Calibration and verification results should be recorded in a register and backed up. 4.The calibration and verification results should be notified to the relevant personnel in a timely manner, and the verification date and validity period should be marked on the equipment.

5.For equipment that fails to pass the verification results, it should be stopped immediately, and repaired and calibrated. 6.

For the equipment with qualified verification results, maintenance and maintenance should be carried out in time to ensure that it is always in good condition. 7.In the process of calibration and calibration, attention should be paid to safety measures to ensure the safety of the operator and the safety of the equipment.

In short, pharmaceutical business enterprises must calibrate and verify equipment in accordance with the requirements of GSP, and ensure the normal operation and safe use of equipment. At the same time, unqualified equipment must be dealt with in time to ensure the quality and safety of drugs.

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 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.

The veterinary drug GSP recognition field key certificate has been cancelled. Since December 1, 2019, the GMP and GSP certification of drugs have been cancelled, applications for GMP and GSP certification will no longer be accepted, and GMP and GSP certificates will no longer be issued. If the on-site inspection is completed before December 1, 2019 and meets the requirements, GMP and GSP certificates will be issued.

Drug Administration Law of the People's Republic of China

Article 3. Drug management should be centered on people's health, adhere to the principles of risk management, whole-process control, and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs.

Drug Administration Law of the People's Republic of China

Article 6. The state implements the drug marketing authorization holder system for drug management. The marketing authorization holder shall be responsible for the safety, effectiveness and quality controllability of the drug in the whole process of drug development, production, operation and use in accordance with the law.