Successive challenge for multi-batch overall pharmaceutical manufacturing control from two-step digital process to OQC strategy by integrated intelligent algorithm

The overall quality consistency (OQC) evaluation of Chinese meteria medica (CMM) from multi-batch is a paramount issue in digital production process. To solve this problem, an industrial information integrated strategy composed with a two-step digital process control and OQC diagnosis strategy are proposed in the complex system of big honeyed pill. The two-step digital control is successively invested to acquire the critical quality attributes (CQAs) so as to excavate the primary parameters to control the consistency from honey refining procedure to He-Tuo procedure especially through online near infrared (NIR) monitoring with physical and chemical attributes. The OQC diagnosis strategy is proposed to figure out multi-batch of OQC from different perspectives by integrating individual method through data fusion approach. As a result, three out of 30 batches of samples are discovered by the information integrated strategy with the weights of 27.82%, 44.60% and 27.58% for NIR, mid-infrared (MIR) and texture technologies. Moreover, the diagnosed samples are executed by the zebrafish efficacy as an in vivo test, which indicates that the OQC diagnosis strategy is a promising method. Besides, the proposed information integrated strategy provides theoretical and practical cornerstones for guaranteeing the multi-batch overall quality especially for the digital and intelligent of CMM industrialization.