Quality Management System
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Quality Management System
Quality Management System
We deliver the highest quality products.
We are Japan’s leading CDMO.
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 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.
- Robust GMP &
QC System - Our GMP-based PQC systems are applied to a wide range of quality tests. All test data are managed by the LIMS systems* at all factories.
Note) As of October 2023, we are promoting the introduction of the LIMS to the Aizu Factory.
- Quality Committee
- Quality Committee holds meetings every month to review the effectiveness of individual GMP systems. The Committee reviews the efficiency and CAPA, the suitability of OOS, complaint management, and the status of the survey results of the contractor and public GMP.
- Document Management System
- Establiseed individual procedures (SOPs) and other documents for each GMP activities and GMP documents are managed by Pharma Document (Electronic QA Document System introduced recently).
- Data Integrity
- The data used for making decisions on developing, manufacturing, testing, delivering, and product monitoring at Bushu Pharma follows the principles of ALCOA+ (Attributable, Legible, Contemporary, Original, Accurate, Complete, Consistent, Enduring and Available).
- Quality Contral
- Robust GMP system based on Japanese GMP, PIC/SGMP, and US CGMP. Have passed inspections by US FDA and other overseas authorities.
CONTACT
As a company specializing in contract manufacturing of pharmaceutical drugs, we offer a wide range of contract services tailored to clients’ needs based on our extensive experience and know-how accumulated over many years.
