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Pharmaceutical /
Life Science

GMP Vector Manufacturing Plant for Tissue Engineering, Courtesy of I’ROM Group Co., Ltd./ID Pharma Co., Ltd.

Supporting Services for FDA / EU Inspections

  • Chiyoda provides pharmaceutical manufacturers with support for FDA/EMEA inspections.
  • Chiyoda offers the following supporting services:
    • Mock inspection/GMP audit
    • Support for FDA pre-meetings/witnessing
    • Consulting services for inspections
    • Support validation
    • Support inspections

Inspection Support Services Chiyoda Offered in the Past

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No.Facility typeProductAudit periodChiyoda’s position
1 Commercial
facility
API FDA (CDER) EPC
2 Commercial
facility
API FDA (CDER) EPCV
3 Commercial
facility
API
intermediate
FDA (CDER) Cn (Witness)
4 Commercial
facility
API FDA (CDER) Cn (Witness)
5 Commercial
facility
API FDA (CDER) EPCV (Witness)
6 Commercial
facility
API FDA (CDER) EPCV (Witness)
7 Commercial
facility
Solid
dosage
FDA (CDER) /EU (EMEA) Cn (Witness)
8 Clinical
facility
Solid
dosage
FDA (CDER) /EU (EMEA) V
9 Commercial
facility
Injection FDA (CDER) /EU(EMEA) EPCV
10 Commercial
facility
Injection FDA (CDER) V
11 Commercial
facility
API FDA (CDER) Cn (Witness)
12 Commercial
facility
API
intermediate
FDA (CDER) Cn (Witness)
13 Commercial
facility
Dosage FDA (CDER) V, (Witness)
14 Clinical
facility
Dosage EU (EMEA) Cn
15 Commercial
facility
Dosage FDA (CDER) V, (Witness)

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E:
 Engineering
P:
 Procurement
C:
 Construction
V:
 Validation Cn:  Consulting