Documentos de Académico
Documentos de Profesional
Documentos de Cultura
A. cGMP
WHO
PIC/S
ISO
B.
4~3334~96GMP
C. GMP
D.
GMP
1998PIC/S
1021143
(TFDA)
2014PIC/S GMP
PIC/S
Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Cooperation Scheme
E. GMPPIC/S
GMPPIC/S
PIC/S GMPGMP
GMPQA/QC
PIC/S GMP+GMP
()
PIC/S
KPEC Bio-Pharm - K.S Cheng
A.
B.
C.
D.
Validation Definition
Why Validation ?
Validation Types
Qualification and Validation
A. Validation Definition
The ongoing process of establishing documented
evidence which provides a high degree of
assurance that a system will consistently perform
according to its predetermined specifications and
quality attributes.
B. Why Validation ?
To prove that the processes works (consistently
and for its intended use) before starting
manufacturing.
C. Validation Types
Process Validation
- Prospective Validation
- Concurrent Validation
- Retrospective Validation
Cleaning Validation
Change Control
Revalidation
10
Documentation
Qualification
Process Validation
Cleaning Validation
Change Control
Revalidation
11
URS
Qualification
PQ
Verifies
Validation
Process Validation
Cleaning Validation
FAT
FS
OQ
Verifies
DS
PDI
Verifies
Revalidation
IQ
SYSTEM BUILD
ISPE Baseline Guides Volune 5 : Commissioning and Qualification
KPEC Bio-Pharm - K.S Cheng
12
13
14
Installation Qualification
Operational Qualification
Performance Qualification
15
Prospective Validation
1)
2) ()
16
Retrospective Validation
17
Change Control
18
19