Sterile drug GMP transition period has ended, but GMP certification of sterile drugs is still in progress. In 2014, the regulatory authorities will conduct timely follow-up inspections on companies that have passed certification to ensure that companies continue to implement GMP in production and ensure that the quality of pharmaceutical production does not decrease.
On March 12, Shen Chuanyong, deputy director of the Food and Drugs Audit and Inspection Center of the State Food and Drug Administration, introduced the newly revised pharmaceutical GMP implementation at the 2014 annual meeting of the China Medical and Pharmaceutical Engineering Association. He said that through the newly revised implementation of pharmaceutical GMP, China's pharmaceutical industry Industry upgrades its software and hardware, but the concept of corporate quality management needs to be further improved.
According to Shen Chuanyong's introduction, the defect analysis and statistics of on-site examination of drug production found that the defects were concentrated in quality management, quality control and quality assurance and plant facilities, followed by document management, production management, equipment, confirmation and verification, materials and products. , agencies and personnel, etc. There are fewer defective items in the shipment and recall of products, self-inspection, commissioned production and commissioned inspections.
In the early stage of the implementation of the newly revised drug GMP, there were many problems with hardware such as factory facilities, but now the software is more prominent. Defective items such as quality management, quality control, and quality assurance appear more intensively in aspects of quality system, deviation handling, change control, product quality review analysis, sampling inspection, and sterility inspection.
At present, the certification of non-sterile medicines is carried out by the provincial drug administration departments. It is reported that in order to ensure the orderly conduct of the certification work and the uniform implementation of the standards, the State Administration of Administration will issue drug GMP certification assessment standards and defects, and strengthen the supervision and spot check of the provincial bureau. The supervisory work is mainly to assess the provincial bureau's ability to inspect and verify. Spot checks are conducted on the enterprises that have already passed the certification by the provincial bureau, and are compared and evaluated by the State Administration of Surveying and the provincial bureau inspections.
In particular, high-risk varieties such as blood products, vaccines, Chinese medicine injections, and multi-component biochemicals will be formulated with detailed follow-up inspection programs, strictly organized and implemented, making full use of various types of regulatory measures, and increasing the intensity of follow-up inspections. Companies that do not meet the requirements of follow-up inspections should take appropriate regulatory measures in a timely manner.
According to the plan, the transition period for non-sterile medicines will end in 2015. According to the estimation of the process, the newly revised application and inspection of GMP certification of non-sterile medicines will enter the peak in 2014.
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