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GMP Validation Services

It is the objective of Pharmaceutical Companies to save lives by providing safe products to consumers. However during the production period, errors may occur or wrong method was applied which may result to substandard or potentially dangerous products, and consequently product recalls is inevitable. For these reasons, Pharmaceutical Companies must have a thorough, safe and effective quality manufacturing system in place.

Sanko is fully capable of providing the GMP-based Validation Services necessary to satisfy this high demand and produce reliable results. We have a more practical approach on certification based on our quality assurance system and proven track record.

 

In order to meet the diverse requirements of the GMP Guidelines, we offer consultation and support on a wide range of services on CSV (Computerized System Validation) such as DQ, IQ, OQ, creation of SOP for calibration, etc. We also support proposals on behalf of customers when they upgrade their factory equipment and systems.

History

We began our activities at the same time GMP was adopted in Japan. For more than 30 years, we have been involved with Pharmaceutical Companies on the validation of medicine, drug clinical trials, manufacturing facilities and equipment.

1980 Founding member of the International Society of Pharmaceutical Engineering (ISPE)
1983 Received orders for developing a control system for the vitamin synthesis equipment. A pioneer for supplying this system
1987 Development of a control system for medicine coating equipment
1990 Development of a control system for manufacturing equipment automation and networking
1992 Participated in a subcommittee for creating a "Computer Validation Manual" (Ministry of Health and Welfare)
1994 Attended a GMP seminar sponsored by KMI (Kemper Masterson Inc.)
(Note : KMI is currently acquired by Parexel International Inc.)
1995 Rockwell Corp., KMI and Sanko Computer Software Co., Ltd. (SCS) held a round table meeting about GMP Validation together with other Pharmaceutical and Engineering Companies.
1997 - 1998 Consulted with US Pharmaceutical Companies regarding VE Plant Equipment Controls
2001 Rockwell Corp., Brock Solution Inc. and Sanko Computer Software Co., Ltd. (SCS) participated in an exchange of opinions about the "Title 21 CFR Part 11" in the United States
2003 Received consultation with Brock Solution Inc. about the "Title 21 CFR Part 11" Regulation

CSV (Computerized System Validation) Implementation

The following are our principal services that complies with the CSV guidelines for developing the customer's control systems management.

  • Design Qualification (DQ)
    • Documentation for User Requirements Specification (URS)
    • Risk Assessment
    • Functional Specification (FS)
    • Design Specification (DS)
  • System Tests, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Other Support Services
    • Design Planning
    • Performance Qualification (PQ)
    • Systems Operation Management
    • System Replacement and Retirement Planning

CSVライフサイクル(開発~納入)

Contact us for further information