Quality Assurance Strategy for Continuous Manufacturing

Purpose of quality assurance of pharmaceutical product is to guarantee potency and safety of pharmaceutical product through securing constancy of product quality.

In continuous manufacturing that Pharmira Co. focuses on, raw materials and/or their blended materials are supplied to the manufacturing process continuously during manufacturing process operation and homogeneous and consistent quality products are produced through manufacturing control and quality control adequately set based on scientific knowledge (control strategy).

There is no difference in setting up control strategy between batch and continuous manufacturing in terms of assuring critical quality attributes (raw material, feature of quality of intermediate, product specification, process parameter, in-process control) of product. Continuous manufacturing, however, as the method to assure abovementioned CQA items, adopts measurement technology such as PAT* and it measures/assesses the quality of product & intermediate on real time basis so that we can aim for achieving targeted quality continuously by adjusting process parameter flexibly against fluctuation during operation.

Pharmira Co., under Shionogi group’s quality policy, structures quality assurance system to apply for continuous manufacturing and takes up innovation and continual improvement to realize stable supply.

* Process Analytical Technology: Technology that designs, analyzes and administrates manufacturing process by real time monitoring to assure product quality.