CFDA Issues Phase 5 Drug Quality Announcement

Source: CPHI 2014-9-1 recently, the State Food and Drug Administration issued the latest drug quality announcement (the fifth issue in total), which announced 148 items such as glimepiride tablet, Xiaohuoluo pill, sanqishang tablet, hepatitis B surface antigen diagnostic reagent, sodium bisulfite, etc The quality sampling inspection of 13461 batches of products and 99 batches of drugs that fail to meet the standard after inspection The overall quality of the sampled drugs is in good condition, but it also reveals some defects in the purchase of raw and auxiliary materials, production process control, sterility guarantee level and other aspects of individual drug manufacturers, and some enterprises and units still have some problems in the condition guarantee of drug transportation and storage The unqualified items of drugs found in the sampling inspection are: content determination and identification, dissolution, disintegration time limit, related substances, microbial limit, content uniformity, filling quantity difference, weight difference, visible foreign matters, clarity and color of solution, etc The State Food and drug administration has organized the relevant provincial (District, city) food and drug supervision and administration departments to take necessary control measures in time for the drugs found in the sampling inspection that do not conform to the standards, and to investigate and deal with the relevant production enterprises and the sampled units according to law At the same time, relevant enterprises and units are required to carefully inspect, thoroughly investigate the causes and carry out rectification, effectively eliminate the hidden dangers, and ensure the quality and safety of drugs.