This function is a core part of our Bushu Pharma’s Quality Management System. Three key areas that are focused on to ensure all products meet quality requirements for the Japan market are:

1. Inspection of the cosmetic quality of bulk drug products

2. Inspection of the cosmetic quality of packaged products

3. Analysis for the presence of foreign materials

In order to meet market expectations for quality control in each of these areas, we employ the general following practices.

• Solid Dosage products: the cosmetic quality of bulk drug product can either be inspected by automated inspection machines or well-trained operators, and defects – such as foreign materials, dirty spots, chipped tablets, pigment agglomeration, etc. – can be removed accordingly.
• Injectable products: foreign materials in filled vials and syringes manufactured overseas can be inspected by highly-trained operators to remove defects – such as small glass fragments and fibers – to meet Japanese market requirements.
• Finished products: the cosmetic quality of finished drug products can be inspected by well-trained operators who remove defects – such as dents or scratched carton boxes.
• Foreign materials: well experienced foreign analysis with various equipment, support process improvement and root cause analysis can be provided.

To implement the above quality control processes, we have highly-experienced inspectors who undergo an annual skill check and training, and we also feature the latest inspection technology – with an Automated Vial Visual Inspection machine installed in 2020 and a new Syringe Visual Inspection Machine set to be installed in 2021.

To support quality control in terms of foreign materials, we make quick response to market complaint and foreign matters found in manufacturing process. Both non-destructive and destructive analysis are available. Our knowledge and experiences of manufacturing is the practical approach the foreign materials from the results of analysis.  As our representative scheme, we make Microscopic observation, Element analysis by X-ray Microscope,  Identification by Raman, and Identification by FT-IR.