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[ Focus on Chemical Machinery and Equipment Network ] For a long time, random inspections of drug quality have been an important measure to use technical supervision to ensure drug quality, and play an important role in cracking down on violations of laws and regulations and improving the supervision capability of the entire industry chain.
Since the beginning of this year, many places across the country have successively conducted spot checks on a large number of drugs, and notified the results of the spot checks.
Chemical machinery and equipment network hotspots pay attention to chemical machinery and equipmentSince the beginning of this year, many places across the country have successively conducted spot checks on a large number of drugs, and notified the results of the spot checks.
For example, recently, Guangdong Province* issued a notice on drug random inspection information (No.
8 of 2020).
Specifically, Guangdong Province randomly inspected 65 drug manufacturers, 649 drug distributors, and 255 medical institutions, with a total of 2,444 batches of 1,063 types of drugs.
The results showed that, among them, only one product and one batch were tested and did not meet the requirements of the drug standards.
8 of 2020).
Specifically, Guangdong Province randomly inspected 65 drug manufacturers, 649 drug distributors, and 255 medical institutions, with a total of 2,444 batches of 1,063 types of drugs.
The results showed that, among them, only one product and one batch were tested and did not meet the requirements of the drug standards.
In addition, on November 11, the Hainan Province* website also released the results of drug random inspections in October 2020.
The results show that in October 2020, a total of 198 batches of drug inspections were completed in the province, of which 197 batches were planned for random inspection, 1 batch for supervision and random inspection, 198 batches of qualified drugs and 0 batches of unqualified drugs.
The results show that in October 2020, a total of 198 batches of drug inspections were completed in the province, of which 197 batches were planned for random inspection, 1 batch for supervision and random inspection, 198 batches of qualified drugs and 0 batches of unqualified drugs.
From the above comprehensive point of view, my country's drug safety situation is generally stable and controllable, and drug quality has continued to be maintained at a relatively high level.
In fact, according to the "Annual Report of National Drug Sampling Inspection", the total pass rate of national drug sampling inspections in 2018 was 97.
1%; and the total pass rate in 2019 has reached 98.
86%.
In fact, according to the "Annual Report of National Drug Sampling Inspection", the total pass rate of national drug sampling inspections in 2018 was 97.
1%; and the total pass rate in 2019 has reached 98.
86%.
However, drug supervision is an important measure to ensure the quality of drugs, and there is no room for slack.
Although the quality of medicines has been maintained at a relatively high level, the current sampling activities of medicine quality throughout the country are still in full swing with the continuous attention of national policies and the continuous improvement of testing methods.
Among them, sampling inspections of decoction pieces of traditional Chinese medicine are becoming more frequent, and there are often news that decoction pieces of traditional Chinese medicine fail to pass the sampling inspection in the industry.
Although the quality of medicines has been maintained at a relatively high level, the current sampling activities of medicine quality throughout the country are still in full swing with the continuous attention of national policies and the continuous improvement of testing methods.
Among them, sampling inspections of decoction pieces of traditional Chinese medicine are becoming more frequent, and there are often news that decoction pieces of traditional Chinese medicine fail to pass the sampling inspection in the industry.
In addition, it is worth noting that with the formal implementation of the new version of the "Pharmacopoeia" and the "Drug Administration Law", the industry generally believes that in the future, the efforts to rectify drugs, including Chinese herbal medicines, will continue to increase.
For pharmaceutical manufacturers, it will continue to usher in more clear and strict quality requirements.
For pharmaceutical manufacturers, it will continue to usher in more clear and strict quality requirements.
In this context, industry analysts believe that analysis and testing equipment related to drug impurities will play a significant role in drug quality control, and the related equipment market will also usher in a huge room for development.
The reason for this conclusion is that the 2020 edition of the Pharmacopoeia and the new edition of the "Drug Administration Law" both have stricter requirements on impurities.
In particular, the 2020 edition of the Pharmacopoeia has also been revised and increased to a large extent in the detection of chemical impurities, and the overall approach is closer to the standard.
The reason for this conclusion is that the 2020 edition of the Pharmacopoeia and the new edition of the "Drug Administration Law" both have stricter requirements on impurities.
In particular, the 2020 edition of the Pharmacopoeia has also been revised and increased to a large extent in the detection of chemical impurities, and the overall approach is closer to the standard.
It is understood that in the process of drug development and production, impurities may be generated due to unstable ingredients of the raw materials, incompatibility with excipients, or reactions with packaging materials.
The amount of various impurities in the drug will affect the safety of the drug.
Therefore, the identification, quantification, qualitative and control of impurities are essential to ensure the quality and safety of drugs.
The amount of various impurities in the drug will affect the safety of the drug.
Therefore, the identification, quantification, qualitative and control of impurities are essential to ensure the quality and safety of drugs.
In order to better ensure drug safety, relevant pharmaceutical equipment companies have already begun to innovate and upgrade drug impurity analysis and testing equipment.
For example, the ZW-3 ultraviolet analyzer developed and produced by an enterprise can be used to check the quality of various fluorescent drugs such as hormone alkaloids and vitamins in drug production and research.
Pharmaceutical equipment For example, the ZW-3 ultraviolet analyzer developed and produced by an enterprise can be used to check the quality of various fluorescent drugs such as hormone alkaloids and vitamins in drug production and research.
At present, with the continuous development of technology, these instruments used to detect impurities are playing an increasingly important role in the quality control of drugs.
It is worth mentioning that with the continuous development of intelligent technology, intelligent technology has also begun to be widely used in the field of these instruments.
For example, the drug impurity and foreign body detector developed by a company adopts intelligent identification technology, which has self-learning and The memory function can automatically recognize and remember the characteristics of the product, and effectively eliminate the interference caused by various "product effects".
detector It is worth mentioning that with the continuous development of intelligent technology, intelligent technology has also begun to be widely used in the field of these instruments.
For example, the drug impurity and foreign body detector developed by a company adopts intelligent identification technology, which has self-learning and The memory function can automatically recognize and remember the characteristics of the product, and effectively eliminate the interference caused by various "product effects".
In general, the identification, quantification, qualitative and control of impurities are of great significance to the control of pharmaceutical quality and safety.
In the future, with the continuous development of technology and the continuous optimization of production processes, the presence of impurities in drugs that have no therapeutic effect or affect the efficacy and stability of drugs will be gradually improved, and the quality and safety of drugs will also be better guaranteed.
In the future, with the continuous development of technology and the continuous optimization of production processes, the presence of impurities in drugs that have no therapeutic effect or affect the efficacy and stability of drugs will be gradually improved, and the quality and safety of drugs will also be better guaranteed.
Original title: In order to ensure the quality and safety of drugs, the upgrade and innovation of testing equipment need to be accelerated
