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

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）

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