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Quality Assurance Q.A. System
Q.A. System
ISO9001 Certification
ISO9001: INTERNATIONAL QUALITY MANAGEMENT SYSTEM
QUALITY STANDARD: ISO9001:2008 JISQ9001:2008
SCOPE OF SUPPLY: Research, Development and Manufacture of Organic Chemical Products including Chemicals, Flavors and Fragrances and Food Additives
SITES: Head Office,Kobe Factory, Tokyo Office
CERTIFICATION BODY: Bureau Veritas Japan Co., Ltd.
ACCREDITATION BODY: United Kingdom Accreditation Service (UKAS)
CERTIFICATION No .: 78399
APPROVAL DATE: January 23, 2001
GMP management
Bulk pharmaceuticals
E DL-Menthol, DL-Camphor, D-Camphor, Eucalyptus oil,
Turpentine oil, Gefarnate,Crotamiton
E Custom synthesis items
GMP Management General Index
y1z General Rules
1. GMP Organization
2. Duty of Pharmaceutical Management Administrator
3. Duty of Manufacturing Management Administrator
y2z Manufacturing Control Protocol
y3z Hygiene and Sanitation Control Protocol
y4z Quality Control Protocol
y5z Validation Protocol
1. Organization of Validation Control
2. Validation Implementation Protocol
3. Form of Validation Planning and Report
4. Calibration Protocol
y6z Customer Complaint Handling Protocol
1. Complaint Handling Procedure
2. Form of Complaint Handling Report
y7z Product Recall Protocol
1. Product Recall implementation Protocol
2. Form of Product Recall Report
3. Recalled Product Treatment Protocol
y8z Internal Inspection Protocol
1. Internal Inspection Implementation Protocol
2. Form of Internal Inspection Report
y9z Education and Training Protocol
1. Education and Training Implementation Protocol
2. Form of Education and Training Planning and Report
3.Annual Plan of GMP Education and Training

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