GSP is the abbreviation of Good Supply Practice, which means product supply specification, is a set of management procedures to control all the factors that may cause quality accidents in the distribution of pharmaceutical commodities, so as to prevent the occurrence of quality accidents.
Pharmaceutical commodities in its production, operation and sales of the whole process, due to the role of internal and external factors, may occur at any time the quality of the problem must be in all these links to take strict measures to fundamentally ensure the quality of pharmaceutical commodities.
GSP is the English abbreviation for Good Manufacturing Practice, which is a unified quality management guideline for pharmaceutical enterprises. Pharmaceutical business enterprises should meet the GSP requirements within the time specified by the drug regulatory authorities and obtain the certificate of accreditation through certification.
GSP provides enterprises with a scientific system of quality management ideas. The implementation of GSP certification will promote fundamental changes in business ideas and business organizational structure, conducive to the development of enterprises, is China's pharmaceutical and international pharmaceutical convergence of the road.
Expanded Information:
According to the deployment of the State Drug Administration, all the drug business enterprises through the current license renewal, will be in the three to five years time for GSP certification, failed to obtain the GSP certification of the enterprise, in the next round of drug business enterprises will be canceled in the next round of drug business enterprises to renew the license of the qualification of the operation of drugs.
Therefore, the implementation of GSP will play an important role in changing the status quo of too many and too many drug business enterprises and the chaotic order of drug business, promoting drug business enterprises to improve the level of management, and facilitating the economic restructuring of the drug business industry.
Features of GSP:
1. The current GSP is issued by the State Drug Administration in the implementation of the State Drug Administration has a mandatory administrative regulations, is China's first into the scope of the law of the GSP. the past GSP is issued by the state-owned main channels of the higher management departments or the pharmaceutical industry departments in charge of the release of the obvious color of the industry management is only a recommended The GSP is an industry management standard.
2. The scope of commodities managed by the current GSP has been changed to those medicines that are in line with the international standards and are completely consistent with the scope of management of the Drug Administration Law. In the planned economy due to the existence of pharmaceutical business sector in the pharmaceutical business and herbal medicine business two major systems, GSP by the pharmaceutical industry authorities to develop, naturally, the scope of management of the GSP is determined as drugs, medical devices, chemical reagents and glass instruments four major categories of pharmaceutical commodities.
3. The current GSP in the structure of the document on the quality of pharmaceutical wholesale and retail of drugs and pharmaceutical quality requirements are expressed in separate chapters to facilitate the actual implementation. The previous GSP on the wholesale and retail of drugs without separate requirements, to the actual implementation of some conceptual ambiguity and operational inconvenience.
4. The current GSP more fully absorbed the theoretical achievements of modern quality management, in particular, the drug business enterprises to establish a quality system, and the basic requirements for its effective operation. In the structure of the quality system components and the drug business process is closely integrated, the line is very clear and smooth.
5. The current GSP in the specific management of the content of some bold trade-offs, remove some unrealistic requirements, so that it is more practical guidance. For example, decisively deleted the original GSP "comprehensive quality management" (TQC) of the relevant content. Strictly speaking, the scope of management of TQC is much larger than the GSP, and fully encompasses the GSP, in the GSP requirements for the implementation of TQC is illogical.
6. The current GSP and some of the newly released administrative regulations on drug management have been better articulated. For example, it reflects the relevant management requirements of administrative regulations such as "Measures for the Classification and Management of Prescription Drugs and Non-prescription Drugs", "Measures for the Supervision and Management of the Circulation of Pharmaceuticals (Provisional)", and "Measures for the Administration of Imported Pharmaceuticals", etc.
7.
7. The main body of the supervision and implementation of the current GSP has become the drug administration and law enforcement departments, which ensures that the GSP is fully implemented in all drug business enterprises in the whole society. In the past, although the GSP is required to be implemented in all pharmaceutical enterprises, but due to the supervision and implementation of the means of ineffective, only in the state-owned pharmaceutical enterprises have been implemented to a certain extent.
8. The current GSP is a technical barrier to drug market access. In order to speed up the implementation of the GSP and reflect the implementation of the GSP mandatory, the implementation of the GSP will be combined with the confirmation of the qualifications of pharmaceutical enterprises.
References: