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 |