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About Maruishi
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Quality, Safety and Regulatory Affairs Management Division
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QA, RA, PV, and Medical Information Division
Coherent quality assurance, pharmacovigilance and regulatory
management system from R&D to post-marketing

The Revised Pharmaceutical Affairs Law enforced in April 2005 established Good Quality Practice (GQP) and Good Vigilance Practice (GVP). Marketing authorization holders are required to strictly comply with both practices.
Following the Revised Pharmaceutical Affairs Law, the quality assurance manager and the safety control manager are appointed under the general marketing manager, the superintendent. Proper and smooth conduct of quality management and safety assurance duties are achieved through close collaboration of the quality assurance manager and the safety control manager. Furthermore, compliance is ensured by working closely with the Pharmaceutical Regulatory Affairs the Auditing, Quality Assurance and Pharmacovigilance Department responsible for assuring R&D study data. Through this framework, the Quality, Safety and Regulatory Affairs Management Division have realized coherent quality assurance, pharmacovigilance and regulatory management system ranging from R&D to post-marketing.
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