cGMP

KPEC Bio-Pharm - K.S Cheng


A. cGMP

WHO

PIC/S
ISO

KPEC Bio-Pharm - K.S Cheng

B.

4~3334~96GMP

KPEC Bio-Pharm - K.S Cheng


C. GMP

21 CFR Part 210226

Part 210 - cGMP; General
Part 211 - cGMP for finished pharmaceuticals
Part 216 - Pharmacy compounding
(withdrawn/removed drug products)
Part 225 - cGMP for medicated feeds
Part 226 - cGMP for type A medicated articles
21 CFR Part 11
Guideline

CFR Code of Federal Regulation

KPEC Bio-Pharm - K.S Cheng


D.

GMP

1998PIC/S
1021143
(TFDA)
2014PIC/S GMP

PIC/S
Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Cooperation Scheme

KPEC Bio-Pharm - K.S Cheng


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

KPEC Bio-Pharm - K.S Cheng

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.

KPEC Bio-Pharm - K.S Cheng

B. Why Validation ?
To prove that the processes works (consistently
and for its intended use) before starting
manufacturing.

To prove that the processes fulfils GMP in order

to get acceptance from authorities to start
manufacturing.
GMP

KPEC Bio-Pharm - K.S Cheng

C. Validation Types
Process Validation
- Prospective Validation
- Concurrent Validation
- Retrospective Validation
Cleaning Validation
Change Control
Revalidation

KPEC Bio-Pharm - K.S Cheng

10

D. Qualification & Validation

PIC/S GMPAnnex 15Qalification
Validation
Planning for Validation

Documentation

Qualification

Process Validation

Cleaning Validation

Change Control

Revalidation

KPEC Bio-Pharm - K.S Cheng

11

D. Qualification & Validation

V-MODEL Direct Impact System
Commissioning

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

D. Qualification & Validation

URS User Requirements Specification
FS Function Specification
DS Design Specification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
FAT Factory Acceptance Test
PDI Pre-Delivery Inspection

KPEC Bio-Pharm - K.S Cheng

13

D. Qualification & Validation

The Validation Process

KPEC Bio-Pharm - K.S Cheng

14

D. Qualification & Validation

Qualification
Design Qualification

Installation Qualification

Operational Qualification

Performance Qualification

KPEC Bio-Pharm - K.S Cheng

15

D. Qualification & Validation

Validation
Process Validation

Prospective Validation

1)
2) ()

KPEC Bio-Pharm - K.S Cheng

16

D. Qualification & Validation

Process Validation
Concurrent Validation

Retrospective Validation

KPEC Bio-Pharm - K.S Cheng

17

D. Qualification & Validation

Validation
Cleaning Validation

Change Control

KPEC Bio-Pharm - K.S Cheng

18

D. Qualification & Validation

Validation
Revalidation

KPEC Bio-Pharm - K.S Cheng

19