Quality Assurance / Management System

Quality Assurance / Management System
Product Description

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 400 experienced staff in our quality assurance and quality control departments to ensure the best products for our customers.
- GMP certification from 43 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

Read more Show less

Bushu Pharmaceuticals Ltd.

  • JP
  • 2015
    On CPHI since
View company profile
Categories
more categories Show less

Bushu Pharmaceuticals Ltd.

  • JP
  • 2015
    On CPHI since
View company profile

More Products from Bushu Pharmaceuticals Ltd. (16)

  • Animal Healthcare Products

    Product Animal Healthcare Products

    We manage animal healthcare products and have manufacturing licenses for both animal healthcare products, animal healthcare biological products, and medical devices.

    Our experts are able to respond to the needs associated with veterinary medicine. Industrial transfers can be made smoothly through th...
  • Regeneration Medicine Assembly

    Product Regeneration Medicine Assembly

    Bushu managed Packaging for Regeneration Medicine
  • Benefits for our clients

    Product Benefits for our clients

    Bushu has committed the Production Capacity, Flexibility and Growth for global clients as an Asia Pacific Hub.

    - Production capacity: 3 billion tablets/year and others
    - Back-up site: Provide Kawagoe and Misato factories
    - Stable product supply: Business Continuity Plan (BCP...
  • Analysis for quick response to in-market complaints

    Product Analysis for quick response to in-market complaints

    If there is a consumer complaint or an issue in the manufacturing process, a timely response is required.
    Both non-destructive and destructive analysis is available. Knowledge and experience of manufacturing for foreign materials based on the results of analysis.

    Methodology
    1. Micr...
  • Business model and strategic drivers

    Product Business model and strategic drivers

    1. Business model
    - For global clients by Japanese high standard 
    - Total management for Contracted Development Manufacturing Organization (CDMO)
    - To be a good business partner like a group company of the customer in their Supply Chain Loop Bushu has covered from development to formulat...
  • Business Continuity Planning (BCP)

    Product Business Continuity Planning (BCP)

    Bushu Pharma, as a CMO, has a social and patient responsibility to ensure the smooth, continuous production of pharmaceuticals - even in the face of a national disaster.
    Bushu Pharma offers a very strong BCP system for its customers – allowing bulk and final product inventory to be reduced. The prepar...
  • Project Management and Consultation

    Product Project Management and Consultation

    Bushu Pharma proactively manages projects with the right team of specialists in technical transfer, packaging, formulation, qualification and validation, production, regulatory affairs, quality management, and supply chain management for new product from kick-off to validation batches.
    ...
  • Supporting your Global Expansion

    Product Supporting your Global Expansion

    Using the production capacity of our two factories in Japan, Bushu Pharma supports both Japanese and global pharmaceutical companies looking to launch their products in new markets.

    We closely communicate with you from project kick-off to actual product launch, we will ensure we are the best par...
  • Export to Asian Pacific Markets

    Product Export to Asian Pacific Markets

    Bushu has followed PIC/S and GMP/GDP.
    - QC test according to USP, EP, JP and Chinese pharmacopeia
    - Serialization packaging for South Korea and others
    - Control process room temperature within each country's regulations
    - Storage for stability test for climate zone IVb
  • New product launch support for Japanese and Asian markets

    Product New product launch support for Japanese and Asian markets

    Bushu has supported many global clients to launch new products for Japanese and global markets.

    Bushu has close communication with client from kick-off to launch for the following items:
    - Project management
    - Technical transfer - Artwork
    - Packaging specifications ...
  • High potency product

    Product High potency product

    We manufacture formulation of high potency products ranging from clinical samples to pharmaceuticals Our manufacturing environment is based on hazard assessment, exposure assessment, and implementing strict residue management.

    In addition, we monitor the environment and verify the containment b...
  • Cold Chain Management

    Product Cold Chain Management

    Many pharmaceutical and biologic drugs today are extremely sensitive to the conditions in which they are packaged, shipped and stored, with temperature deviations affecting the quality of product delivered. Bushu Pharma is skilled in the management of these factors and will ensure your products are handled...
show all 16 other products

Bushu Pharmaceuticals Ltd. resources (2)

  • Amgen and Bushu Pharma Announce Expanded Supply Chain Partnership across Japan and Asia-Pacific Region

    News Amgen and Bushu Pharma Announce Expanded Supply Chain Partnership across Japan and Asia-Pacific Region

    - “Gateway to Asia” Contract Manufacturing Organization (CMO) Agreement to Double Volume of Drugs Produced for Amgen by Bushu Pharma -
    25 Nov 2021
  • New SCM service Gateway to Asia

    Brochure New SCM service "Gateway to Asia"

    Bushu Pharma's "Gateway to Asia" service supports customers in their desire to launch new products in Japan and across the larger Asian region. Our Gateway to Asia service lets international pharmaceutical companies import bulk products into Japan for quality inspection, labeling, packaging and distribution throughout Japan and other Asian countries. The service lets you focus on your core businesses and avoid having to deal with the difficult process of managing lead-time, temperature, security, inventory, packaging and urgent order handling across multiple markets.
    Collectively, our services offers reduction of lead time from purchase order to shipping, financial and physical flow, oversight of inventory management for Asian markets, forecast review, and planning and operations based in GMP expertise.