Quality Assurance & Process

Bushu Pharma's commitment to quality assurance - reaching and exceeding the standards often associated with Japanese manufacturing

Our employees are well trained in the company's quality assurance procedures.

Key Elements of our Quality Assurance Procedures

  1. A robust GMP system based on Japanese GMP, PIC/S GMP, and US cGMP, which has passed inspections by US FDA and other overseas authorities.
  2. A quality committee meeting held monthly to review the effectiveness of individual GMP systems. The Committee reviews the effectiveness and CAPA, the appropriateness of OOS, complaint management, and the status of the survey results of the contractor and public GMP.
  3. Established individual procedures (SOPs) and other documents for each GMP activities and GMP documents are managed by Parma Document, an electronic QA Document System that we have recently introduced.
  4. The data used for making decisions on developing, manufacturing, testing, delivering, and product monitoring at Bushu Pharma follow the principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available)
  5. A wide variety of tests can be performed by QC. LIMS (Laboratory Information Management System) is used in the QC Lab as well.

Going forward, Bushu Pharma remains dedicated to delivering the highest levels of Japanese craftsmanship and disciple in the manufacture, analysis, and distribution of pharmaceuticals and other medical products.

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