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Integrated Plant Management System for Meeting Operational Changes in Drug-manufacturing Industry Due to Revision of Pharmaceutical Laws |
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AUTHORS |
| Satoru Serizawa |
MES/Environment Solution Dept., Industrial Manufacturing & Services Systems Div., Information & Telecommunication Systems, Hitachi, Ltd. |
| Mamoru Matsumoto |
Pharma and Biotech System Dept., Total Solutions Div., Hitachi, Ltd. |
| Shinsuke Kataoka |
Pharma and Biotech System Dept., Total Solutions Div., Hitachi, Ltd. |
| Yasuyuki Suzuki |
Solution System Div. 2, Hitachi Information & Control Systems, Inc. |
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OVERVIEW |
In recent years, international harmonization of regulations between the pharmaceutical industries of Japan, the USA, and the EU has been progressing steadily. Following this trend, Japan will enact a revision of the Pharmaceutical Affairs Law in April 2005. As for the revised Pharmaceutical Affairs Law, safety measures regarding medical equipment and products of biological origin have been reviewed. A point of note in this revised law is the revision to the system for approval and authorization of drug manufacturing. As a result of the revision to the system for approval and authorization, it has become possible to completely separate the manufacturing and sales of drugs. Changes in the drug-manufacturing business—such as spinning off of the production sector of the pharmaceutical industry—are being anticipated, and commissioned manufacturing is expected to expand even more in the future. Providing solutions for the increased number of commissioned manufacturers in the future, Hitachi has developed an integrated plant-management system based on Hitachi pharmaceutical plant management system. As a result of implementing this system, the system requirements of commissioned manufacturers can be integrated and satisfied by a single package.
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RELEVANT SITES |
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KEYWORDS |
HITPHAMS, MES, pharmaceutical, manufacturing execution system
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