Perspectives & Review
CAO Meng, GE Yuanyuan, HU Yanchen, WANG Yamin, CAO Yi
With the release of the International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use(ICH) Q13 guideline and the approval of several oral solid dosage form drug products
adopting continuous manufacturing techniques, the regulatory development in this area is receiving increasing attention.
Material handling is an important part of a continuous manufacturing platform. In this paper, the material handling
for continuous manufacturing of oral solid dosage forms is introduced through analyzing the technical characteristics
of material input, continuous feeding and continuous mixing. Also, the concerns of supervision and inspection are
studied from the aspects of process validation, robustness, facilities and equipment, process control, quality assurance
and cleaning. For technical consideration, process equipment should handle materials continuously and stably, with
risks controlled and losses reduced as much as possible, so it is necessary to have a deep understanding of material
characteristics, scientifically design process equipment and carry out qualification and verification; while regulatory
inspections may focus on continuous process-specific risks and their possible effects on product quality. Hopefully this
paper could accelerate the application of continuous manufacturing in pharmaceutical industry together with the aid of
cooperation of regulation agencies, industrial community as well as the whole society, making full use of process analysis
technology, innovative testing methods and digital quality assurance to steadily manufacture qualified products, thus
promote domestic pharmaceutical industry to a high level of modernization.
