Recently, the State Food and Drug Administration issued the latest issue of the drug quality announcement (the sixth issue of the total), announcing the quality and quantity sampling inspection of 3200 batches of 21 varieties of drugs, including acyclovir eye drops, paclitaxel injection, cassia twig tuckahoe pills, lactobacillus dispersible tablets, and compound houttuynia tablets, as well as 45 batches of drugs that failed to meet the standard after inspection.
The overall quality of the sampled drugs is stable, but it also reveals that some drug manufacturers have certain defects in the production process control, sterility assurance level and other aspects, and some enterprises fail to pass the sampling inspection for several consecutive batches, reflecting the serious defects in the quality management of a few enterprises. Some enterprises and units still have certain problems in terms of drug transportation, storage and other conditions. The unqualified items found in the sampling inspection of drugs that do not conform to the standard mainly include the dissolution, microbial limit, related substances, pH value, moisture, acidity, visible foreign matters, etc. in the content determination and inspection items.
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 for the drugs found in the sampling inspection that do not meet the requirements of the standard, and investigate and deal with the production enterprises and the sampled units according to the relevant provisions. Anhui Province and Jilin Provincial Food and Drug Administration have imposed administrative penalties on Anhui Sanchao Pharmaceutical Co., Ltd. and Jilin Huinan Huifa Pharmaceutical Co., Ltd. for confiscating illegal income and imposing fines. At the same time, relevant enterprises and units are required to carefully inspect, thoroughly investigate the causes and carry out rectification, effectively eliminate hidden dangers and ensure the quality and safety of drugs.
Tips：
The content determination items in the drug standard reflect the content of the active ingredients in the drug.
The inspection items in the drug standard include the safety, effectiveness, limit, uniformity, purity and other contents of the drug. According to the characteristics of different drugs, the inspection items include dissolution, microbial limit, related substances, pH value, visible foreign matters and other sub-items.
Dissolution refers to the rate and degree of dissolution of active drugs from tablets, capsules or granules under specified conditions.
Microbial limit refers to the degree of microbial contamination of non-specified sterilization preparations and their raw materials and auxiliary materials. The inspection items include the number of bacteria, mold, yeast and control bacteria.
Related substances refer to the starting materials, intermediates, polymers, side reaction products, and degradation products in the storage process.
PH value is a convenient expression of hydrogen ion activity in aqueous solution. The pH value is defined as the negative logarithm of the hydrogen ion activity in the aqueous solution, reflecting the acidity or alkalinity of the drug aqueous solution.
Visible foreign matter refers to the insoluble substance that exists in the injection and eye liquid preparation and can be observed visually under the specified conditions, and its particle size or length is usually greater than 50 μ m.
