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Quality Department

Basic Quality Assurance Policy

Shiseido performs safe and accurate inspections using a strict quality control system.

Shiseido provides peace of mind, safety and satisfaction to its customers by performing strict inspections starting from the stage of acceptance testing of raw materials to product shipment and stability testing.

Features of the Quality Department

The quality department performs 3 tasks “Research and Development” “Quality Assurance”, and “Quality Control”.
Transfer of information and efficiency have been integrated by performing these tasks under one department and Shiseido is able to respond to customer demands and inquiries quickly and accurately.
It has been our strength that we are always able to respond to the demands from our customers with the close cooperation between quality, manufacturing and sales departments.

Quality Department Operations

Research and Development

Our company works with the product concept "Relief to see, safe to use and complete satisfaction" and is continuing its Research and Development of drugs and health foods that can contribute to improving the QOL (Quality of Life) of our customers.
Shiseido continues to take up different types of product development challenges leveraging its solid formulation technologies and analysis techniques.

We will take up challenges to improve the QOL of our customers.

Trial Manufacturing

Shiseido will carry out trial manufacturing to ensure that the requirements of our customers are met.
Shiseido will check if there are there any issues with the trial formulations and packaging specifications, confirm the suitability of processes and machines, and verify commercialization of the products.

Quality Assurance

Our aim is to establish Quality Assurance by complying with GQP, GVP and GMP.
Shiseido will comprehensively monitor and supervise all the processes starting from Research and Development and manufacturing up to post marketing surveillance ensuring that each and every product complies with the laws and regulations that have to be followed.

Quality Information Collection

First priority is customer feedback (Preventive and corrective measures)

  • Shiseido will acknowledge all your complaints and use this information to take preventive measures and for product improvement.
  • Shiseido will evaluate the side effects and if required report such information to the Ministry of Health, Labor and Welfare.

教育訓練の様子

Education and Training

Employee education (Monthly – Training for all employees)

  • Shiseido conducts study sessions conducted by external lecturers for all employees every month.
  • The educational contents are designed such that the Board of Directors can also participate actively.

製造所監査の様子

Manufacturing Site Audits

Inspection (Shiseido manufacturing plants are monitored daily by patrolling)

  • Shiseido offers safe products by patrolling all manufacturing plants and any issues observed are reported on a daily basis.
  • Shiseido audits suppliers and ensures that raw material quality is maintained and a stable supply is secured.

Signing Agreements

Signing agreements (Collective management of all documents) etc

  • All types of agreements and specification documents are signed, checked and updated including GQP agreements, and the progress and contents are managed.

Deviations, Changes and Recovery

As a base for quick support (From stand point of a third party)

  • Strict and quick support will be provided after compiling the information for any deviations and changes occurring at the manufacturing sites, and recoveries following distribution.

Quality Control

The manufacturing environment, raw materials and product quality will be checked using various inspection equipment’s in accordance with GMP [Good Manufacturing Practices].
Checks and reviews will performed regularly so that stable quality drugs can be offered.
Shiseido aims to detect unsuitable products at an early stage and quickly investigate the causes.

Raw Material and Product Inspection

Shiseido ensures the quality required for taking decisions on shipment by carrying out acceptance inspection of raw materials, and by performing various tests for intermediate and final products.
In addition, Shiseido checks if the quality trends are uniform with reviews throughout the year, and takes preventive measures so that constant quality can be ensured.

TOC meter

Environment and Equipment Management

Shiseido has established a highly secure environment by managing the degree of cleanliness of the manufacturing environment and the water used for manufacturing.
Shiseido strives to take preventive measures by reviewing microorganisms and the water used for manufacturing throughout the year, and investigates the trends.
Shiseido suitably manages the calibration of various measuring instruments.

Validation

Manufacturing processes are checked and confirmed to ensure that each process is functioning correctly. The cleaning process is also similarly checked for each product to confirm if there are any problems with the cleaning methods.

Plan→Sampling→Measurement→Conclusion and Inspection→Report

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