What changes have been made to the Code of Quality Management of Pharmaceutical Operations?

Recently, the State Administration of Food and Drug Administration (CFDA) issued the "Decision on the Modification of <>", the "Drug Management Quality Management Code" (GSP) and its contents of the revision has returned to the public eye.
Review of the Revision of the Code of Quality Management of Pharmaceutical Operations
On April 30, 2000, the Code of Quality Management of Drug Operations was published by Order No. 20 of the State Drug Administration; On the 18th, the Second Amendment of the General Administration of Food and Drug Administration of the State Administration was made in accordance with the Decision on the Amendment of the Quality Management Code of the State Food and Drug Administration, adopted by the General Administration of Food and Drug Administration on June 30, 2016 and issued by decree No. 28 of the State Administration of Food and Drug Administration on July 13, 2016. At the same time, the Code of Quality Management of Pharmaceutical Operations (Decree No. 90 of the Ministry of Health of the People's Republic of China), which was implemented by the Ministry of Health on June 1, 2013, shall be repealed.
have you made any changes to the Code of Quality Management of Pharmaceutical Operations?
, according to the relevant document content instructions, "drug business quality management norms" this revision mainly involves three aspects.
. In accordance with the Opinions of the General Office of the State Council on Speeding Up the Construction of the Traceability System for Important Products (State Administration Issued No. 95 of 2015), operational requirements are put forward for how pharmaceutical enterprises in the drug circulation sector implement the drug traceability system.
the mention and operation of the national electronic regulatory code became a fahey, and the amendment removed the contents of the three regulations on the contents of the electronic regulatory code in 81st, 82nd and 102nd. Instead, it is a drug traceability system and instructions for operational requirements. In the newly revised Code of Quality Management of Pharmaceutical Operations (GSP), it is clear that "enterprises shall take effective quality control measures in the procurement, storage, sale and transportation of drugs, ensure the quality of medicines, and establish drug traceability systems in accordance with the relevant requirements of the State, so as to realize drug traceability", and enterprises shall establish computer systems that meet the requirements of management and quality control throughout the operation and achieve drug traceability.
. In accordance with the Decision of the State Council on the Amendment of the Regulations on the Circulation of Vaccines and the Administration of Vaccinations (Decree No. 668 of the State Council), the relevant provisions of the Code of Quality Management of Pharmaceutical Operations on Vaccine Business Enterprises shall be amended to the requirements of vaccine distribution enterprises.
because of the negative impact of vaccine cases in the first half of the domestic and infection efforts, the national level attaches great importance to this, for the quality of vaccine management excellence, resolutely put an end to the re-occurrence of similar cases. Therefore, the quality management and safe transportation of vaccines are very rigorous and strict.
, many times the operation of vaccine flow, transportation, storage, improper monitoring, etc. may cause vaccine quality change. In this new revision of the Drug Business Quality Management Code (GSP), to adapt to the contents of the new regulations of the State Council, strictly supervise the quality management of vaccines, with the scope of vaccine operations and by the vaccine production enterprises commissioned to distribute the business enterprises, still need to be strictly in accordance with the new revision of the Drug Business Quality Management Code (GSP) Article 22 provisions of the allocation of appropriate personnel. The amendment clearly states: "Where the vaccine is distributed, it shall also be equipped with more than 2 professional and technical personnel who are specifically responsible for avoiding quality management and acceptance." According to
the Opinions of the General Office of the State Council on Speeding Up the Reform of the Registration System of the "Three Certificates in One" (No. 50 of the State Administration issued (2015), the consolidated documents to be examined by the first enterprise shall be stipulated as "copies of the documents for business license, tax registration and organization code".
The amendment changes article 62 (2) of the Code of Quality Management of Pharmaceutical Operations to "a copy of the business license and the publicity of the annual report of the enterprise in the previous year" to a "copy of the document of the business license, tax registration, organization code, and the publicity of the annual report of the enterprise in the previous year". This revision on the basis of business license to increase tax registration, organizational code documents, more stringent than before, more rigorous procedures, in response to the State Council "three certificates in one" registration system reform, so that drug management more in line with policies and regulations, quality management more solid and reliable. (HC Pharmaceutical Industry Network)