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With the relevant regulations and appendices of the State Food and Drug Administration not yet fully introduced, some provinces have begun delaying acceptance of enterprises with “two certificates†within the region that are due or are about to expire. After the investigation of professional pharmaceutical logistics research institutions in China, the new version of GSP certification for retail companies is one step ahead.
Many provincial drug regulatory authorities have successively issued acceptance rules for pharmaceutical retailers that meet the new GSP specifications, placing higher demands on retail enterprises. Such as strengthening the management of licensed pharmacists, management of prescriptions, management of cryopreservation medicine (cold chain), computer system management, drug electronic surveillance codes, etc., all have higher standards.
In response to the computer systems of retail enterprises, the new GSP appendix “Pharmaceutical Business Enterprise Computer System†has made requirements. Among them, Article XX clearly stipulates that the computer system of a retail enterprise shall also have the following functions on the basis of complying with the relevant provisions of the Appendix:
1. The system shall automatically identify prescription drugs, specially-administered drugs, and drugs with special management requirements in other countries in accordance with the basic data of quality management to ensure legal and standardized sales;
2. The system shall reject the occurrence of super-quantitative sales of pharmaceuticals that have special management requirements in the country;
3. The system shall interface with the settlement system and invoicing system, automatically print sales tickets for each sale, and automatically generate sales records;
4. The system shall establish separate sales records for the unpacked drugs and implement safe and reasonable sales control for the unpacked drugs;
5. The system shall automatically generate an exhibition drug inspection plan on a regular basis based on the quality management data.
The above regulations require companies to upgrade their own computer systems. The computer system must not only meet the business needs of retail companies, but also control and record the data of the whole business process in real time (the data mentioned here includes the requirements of the quality management system, Upload e-surveillance code). It needs to be emphasized that, according to the requirements of the new version of the GSP, the business process of retail pharmacy companies should embed quality modules into the system. For example, purchasers must purchase approved companies and products. This is the original meaning of quality control.
For another example, for the sale of "hemp products" (including ephedrine compound preparations), the system must control the sales volume (current sales must not exceed two minimum packages). Similarly, the computer system must also be able to control the scope of the business and be able to manage drug displays. These are the highlights of the new GSP.
The new version of GSP certification for retail enterprises took the lead
With the implementation of the new “Pharmaceutical Business Quality Management Regulations†(hereinafter referred to as the new edition of the GSP) on June 1, 2013, many wholesale companies have started to take action, especially the “two licenses†(“Drug Business License†and “Drug Management Quality Management Specification Certificate) The company that is about to expire.