Quality Management System

We deliver the highest quality products.
We are Japan’s leading CDMO.


Overview: Bushu Pharma QMS 4.79 MB 31 downloads


Bushu Pharma strives to be a company highly valued for its contributions to human health through the manufacturing of the finest quality pharmaceuticals. We employ the world-renowned quality system that Japanese manufacturing is known for, calling on more than 200 experienced staff in our quality assurance and quality control departments to ensure the best products for our customers.

We also are proud to offer leading production facilities with long track-records of near-flawless compliance, typically facing over 40 regulator and client inspections each year.

We believe that the ability to ensure the highest level of quality starts from the mindset of each employee. To that point, we emphasize that it is important for each and every employee to have a strong awareness that Bushu Pharma manufactures products which affect human lives and that we should all be committed to producing products with the highest quality attainable in our industry.

In addition to our on-going effort to cultivate a culture of Quality and ensure that all employees operate with a high sense of morality and ethics, we all focus on ensuring quality in all elements of our business - from the processes we use for manufacturing to the way we approach delivery and supply chain management.

We combine these processes and know-how into the Bushu Quality Management System (QMS), which is based on the highest levels of Japan Quality and is accepted by regulatory authorities in multiple countries, including the US FDA. An in-depth understanding of the quality requirements in Japan for the cosmetic quality of bulk drug and packaged products, as well as for analysis of foreign materials, further defines our system.

Key Features of our QMS

  • GMP certification from more than 55 countries
  • Established comprehensive quality assurance system employed to maintain high quality and reliability levels
  • Ability to accurately grasp our customers' needs through close communication provided in English or Japanese
  • Continuous acquisition of new technology in order to further increase production quality levels
  • Established procedures for quality system management that meet international standards
  • Voluntary data management system (LIMS)
  • Responsive actions ensuring data integrity
  • Continuous quality education and training
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