GSP is the abbreviation of English Good Supply Practice, which means product supply specification. It is a set of management procedures to control all factors that may cause quality accidents in the circulation of medical commodities in order to prevent quality accidents.
In the whole process of production, management and sales of pharmaceutical commodities, quality problems may occur at any time due to the influence of internal and external factors. Strict measures must be taken in all these links to fundamentally ensure the quality of medical commodities.
Extended data:
1. The current GSP is a mandatory administrative regulation issued by the State Administration of Pharmaceutical Products, and it is the first GSP in China to be included in the legal scope. In the past, GSP was issued by the superior management department of the state-owned main channel or the competent department of the pharmaceutical industry, which has obvious industry management color and is only a recommended industry management standard.
2. The scope of goods managed by the current GSP is changed to drugs that are in line with international standards and are completely consistent with the scope of management of the Drug Administration Law. Under the condition of planned economy, there are two systems in the pharmaceutical business sector: pharmaceutical business and medicinal materials business. GSP is formulated by the competent department of pharmaceutical industry, and the management scope of GSP is naturally determined as four categories of pharmaceutical commodities: drugs, medical devices, chemical reagents and glass instruments.
Compared with international practice, on the one hand, there are more non-pharmaceutical medical commodities than the last three, and on the other hand, all drugs can not be covered within the scope of drugs (that is, Chinese medicine is not included). Later, state administration of traditional chinese medicine also formulated GSP and its acceptance rules, but it was hardly implemented.
GSP issued by the State Administration of Pharmaceutical Products changes the management scope to simple and complete drugs, which is in line with the international GSP and completely consistent with the concept of drugs in the Drug Administration Law. The Chinese name of GSP was changed from "Good Manufacturing Practices" to "Good Manufacturing Practices".
3. In terms of file structure, the current GSP setting chapters express the quality requirements of drug wholesale and drug retail respectively, which is convenient for actual implementation. In the past, GSP had no separate requirements for drug wholesale and retail, which brought some conceptual ambiguity and operational inconvenience to the actual implementation.
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