GMP and GSP in the pharmaceutical plant are what it means?

1, GMP is a set of mandatory standards applicable to the pharmaceutical, food and other industries, requiring enterprises from raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control and other aspects of the relevant national regulations to meet the health and quality requirements, the formation of a set of actionable operating practices to help companies improve the corporate health environment, and timely discovery of problems in the production process, to improve.

2, GSP is the English acronym for "Good Manufacturing Practice", which is a unified quality management guideline for pharmaceutical companies. Drug business enterprises should meet the GSP requirements within the time specified by the Drug Administration and obtain the certification through the certification.

Difference:

1, the requirements are different

GMP requires that pharmaceutical, food and other manufacturers should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of the final product (including food safety and hygiene, etc.) in line with the requirements of the regulations.

GSP control of the circulation of pharmaceutical commodities all the factors that may occur in the quality of the accident so as to prevent the occurrence of quality accidents in a set of management procedures, pharmaceutical commodities in its production, operation and sale of the whole process, due to the role of internal and external factors, at any time there is a possibility of quality problems, must be taken in all of these aspects of the strict measures in order to ensure the quality of pharmaceutical commodities fundamentally.

2, different publishers:

GMP published by the World Health Organization; the current GSP is the State Drug Administration issued.

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Extended information:

According to the requirements related to the new version of the GMP, a number of pharmaceutical manufacturers are tightening the time for remodeling and certification.

In the "other categories of drugs", solid dosage forms occupy a large part. Commonly used solid dosage forms include bulk, granules, tablets, capsules, drop pills, film, etc., which account for about 70% of drug preparations.

Therefore, as the deadline for the new GMP certification draws nearer and nearer, the transition period left for the relevant enterprises is actually not much. Considering the future development of enterprises and related work, to avoid the certification work "traffic jam" problem, many companies will complete the new version of the GMP transformation and certification of the work in advance to more than half a year, which is also encouraged by the relevant departments.

/baike.baidu.com/item/GMP/405 "target="_blank "title="Only support the selection of a link to take effect">Baidu Encyclopedia-GMP

/baike.baidu.com/item/GSP%E8%AE%A4%E8%AF%81/8358686 AF%81/8358690#2 "target="_blank "title="Support only works when a link is checked">Baidu Encyclopedia-GSP