Researchers from China have developed a new assessment strategy that can be used to check quality of generic drugs developed by varying processes. The strategy is likely to improve the regulatory and decision-making aspects related to pharmaceutical products.
The study, led by Professor Changqin Hu of the National Institute for Food and Drug Control and Professor Xiaomei Ling of Peking University, was published in the Journal of Pharmaceutical Analysis. This paper was made available online on 4th November, 2020 and was published in Volume 11 Issue 5 of the journal on 31st October, 2021.
The researchers designed their study aligning with quality standards of current Good Manufacturing Practice that stressed the “QbD” concept instead of the traditional “quality by test” approach.
Professor Hu explained, “According to QbD concept, quality of drugs can be maintained by ensuring the quality during each step of the design, development and manufacturing process. To develop an evaluation strategy that would assess the commonalities among different processes of generic drug development, we aimed to define universal indicators and methods to characterise different processes used for the same pharmaceutical product.”
A whole gamut of information related to the drug development processes was documented and available in NESTP and other literature, serving as the resource for designing the desired computational model for quality assessment. Based on this information, the researchers developed an evaluation process called “population pharmaceutical quality assessment” for mining the process information related to sample-population quality and investigating intrinsic links between QbD elements. The strategy formulated in this way was found to be adept in the quality and risk assessment of the pharmaceutical process.
Professor Ling elaborated, “Our method provided a scientific tool for objectively and comprehensively evaluating quality consistency and promoting the regulation status of domestic generic drugs.”
To demonstrate the applicability of the new strategy, the researchers performed quality consistency assessment of generic ceftriaxone sodium injections and process risk assessment and population quality trend tracking of generic aztreonam injections. Both assessments offered satisfactory results.
“The newly developed method emerged as an effective and economical means to improve product quality by discovering key issues in drug quality evaluation through data mining. Moreover, the method would likely facilitate timely prediction of various hidden, but avoidable quality hazards, serving the regulatory perspective,” Dr Zhao surmised.
The researchers are hopeful that by leveraging the continuous addition of data in the knowledge base, they can improve their strategy further for superior decision-making regarding drug regulation.