Continuous Production Project Deliverables
In response to the growing interest in continuous production in pharmaceutical manufacturing, the Formulation Research Committee launched the Continuous Production Project.
In Japan, several research results by the research group of the Japan Agency for Medical Devices (AMED), including the "Point to Consider Document on Continuous Manufacturing," have already been published on the website of the National Institute of Health Sciences (NIHS), with the aim of promoting the introduction of continuous manufacturing technology. The "Point to consider" document is available on the website of the National Institute of Health Sciences. In addition, ICH has adopted continuous production as a quality topic, and guidelines have begun to be developed. The currently available documents on continuous production, including the ICH guidelines that are expected to be issued in the future, all outline high-level requirements and considerations, and many pharmaceutical companies are struggling to consider specific measures when actually introducing this technology and considering its implementation in commercial manufacturing, or are anticipating such situations. In order to introduce this technology and consider its implementation in commercial manufacturing, many pharmaceutical companies are struggling to find a specific way to deal with this issue, or are assuming such a situation and not progressing with technology introduction.
In order to help promote the introduction of such manufacturing technologies in the pharmaceutical industry, this project has prepared a document intended to provide examples of specific process development for oral solid dosage forms, which are commonly selected dosage forms, and which are not shown in the guidelines and guidance mentioned above. This document follows the development concept of "Sakura Flowering Tablet P2 Mock" by the already published Sakura Flowering Tablet Mock Subcommittee* and presents an example of a process development method that applies the Quality by Design methodology when the same Sakura Flowering Tablet is manufactured in a continuous production system. The comparison with the "cherry blossom tablet P2 mockup" makes it easier to compare the considerations in building a management strategy based on the difference in production methods. The content presented in this document is only an example, and uniform application of this case study is not necessarily effective or efficient, but we hope that you will use it as a reference when considering the actual situation.
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The document is based on the CMA.MHLW Grants-in-Aid for Scientific Research on Regulatory Science of Pharmaceuticals and Medical Devices, 2012-2014: Research on Quality Assurance of Drug Products throughout Their Lifecycle, Sakura Kaika Tablet Mock Subcommittee