Generic medicines are the patent-expired versions of the branded drugs and given they contain the same active ingredients and intended use as the branded ones they provide a lower cost alternative to produce medicines for poorer communities.
Nonetheless, generic medicines continue to require strict quality assurance and risk assessment, as required by regulatory agencies. To address these cost measures, researchers from China have come up with an innovative strategy, based on the “Quality by Design” concept.
The aim is to more seamlessly enable the quality evaluation of generic drugs developed by different processes. The findings of a new study could improve the regulatory and decision-making aspects related to pharmaceutical products.
The researchers have pitched their approach as an alternative to China’s National Evaluation Sampling and Test Project (NESTP), which is China’s existing domestic generic drug evaluation information source. The concern is that medicines imported from the EU and the U.S. are often manufactured through production processes and process controls different from the Chinese drugs.
The alternative approach has been developed by Professor Changqin Hu of the National Institute for Food and Drug Control and Professor Xiaomei Ling of Peking University.
The researchers stress the “Quality by Design” concept instead of the more traditional “quality by test”. The Quality by Design concept seeks to ensure that the quality of drugs is maintained by ensuring the quality during each step of the design, development and manufacturing process.
For this, the researchers have constructed some universal indicators and methods to characterize different processes used for the same pharmaceutical product. This is around a computational model for quality assessment.
The model produced is an evaluation process termed “population pharmaceutical quality assessment”, and it is used for data mining the process information related to sample-population quality and for investigating Quality by Design elements.
To test out the new strategy, scientists undertook quality consistency assessments of generic ceftriaxone sodium injections and generic aztreonam injections. According to the review, which was subjected to peer review, both assessments provided satisfactory results.
Going forwards, the researchers state that by leveraging the continuous addition of data into their knowledge base together with a science-based approach to risk management, the strategy can be taken further and used for other decision-making regarding medicinal regulation and approval.
The new approach appears in the Journal of Pharmaceutical Analysis. The paper is titled “A strategy for population pharmaceutical quality assessment based on quality by design”.
