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After more than half a year's "runaway", the new GSP certification began to enter the "growth shift period." The issuance of notices provides guidance for companies busy with GSP certification. Judging from the feedback from companies that have already undergone transformation, there is a large one-time investment in hardware. In addition, the defects are mostly reflected in the quality control of the entire circulation process. After the guiding principles are released, enterprises should strengthen process management.
The new version of GSP pays more attention to the management of cold chain in the circulation of medicines. The China Pharmaceutical Business Association also established 9 temperature-sensitive pharmaceuticals circulation safety laboratories for 9 companies including UN-controlled, Kyushu-Tong, and China Resources Medicine. It plans to formulate medicine within 3 years. Cold chain standard.
For distribution companies, the pressure brought about by the temperature and humidity requirements is not an investment in certification, but the difficulty of routine maintenance increases. In order to ensure that the drug in the library meets the temperature requirements, the company must have sufficient air-conditioning equipment and automatic temperature and humidity monitoring and recording system, and also pay special attention to the construction of the basic database.
The relevant documents require that the whole process of cold chain monitoring must be implemented from the time the pharmaceuticals are delivered to the distribution to the retail outlets and then to the warehousing of retail outlets until the final delivery to the consumers. In this regard, the person in charge of related companies said: They are concerned about the product after leaving the factory, such as during the transport period does not meet the required temperature and humidity standards, how to do, how to monitor the store's storage, etc., these need further introduction of supporting rules.
In fact, after the implementation of the new version of the GSP, three implementation time points have been drawn up. By December 31, 2015, all pharmaceutical companies must meet the new GSP requirements. However, at present, due to the fact that most pharmacies that have expired certificates cannot find enough licensed pharmacists, after the first point of time expires (ie, the certificate expired before December 31 last year but cannot be completed), the validity of the application can be extended until June 2014. 30th.
Although there will be a process for each province to implement these guidelines, GSP certification will accelerate in any case, and the industry reshuffle will become more apparent in the next two years.
New version of GSP Certification Accelerates Cold Chain Management
Recently, CFDA issued the "Notification on Guidelines for On-Site Inspection of Pharmaceutical Business Quality Management Regulations." The document has a detailed description of the circulation of pharmaceuticals, with particular emphasis on two key aspects of drug supervision - drug purchase and sales channels and storage temperature and humidity control.