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 type | Product | Audit period | Chiyoda’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 |