Gamp 5

1. GAMP 5
PHARMACEUTICAL
PROJECT VALIDATION
&
QUALITY RISK
MANAGEMENT

2. GAMP
‫الجودة‬ ‫متطلبات‬ ‫يحقق‬ ‫المنتج‬ ‫أن‬ ‫من‬ ‫التأكد‬ ‫على‬ ‫المستخدم‬ ‫تساعد‬ ‫التي‬ ‫واإلجراءات‬ ‫القواعد‬ ‫من‬ ‫مجموعة‬
‫التصنيع‬ ‫مراحل‬ ‫من‬ ‫مرحلة‬ ‫كل‬ ‫من‬ ‫جزء‬ ‫أو‬ ‫مبنية‬ ‫تكون‬ ‫أن‬ ‫يجب‬ ‫ولكن‬ ‫قياسها‬ ‫يمكن‬ ‫ال‬ ‫الجودة‬
‫الى‬ ‫المستخدمة‬ ‫واآلالت‬ ‫والمعدات‬ ‫للمعمل‬ ‫المخصص‬ ‫البناء‬ ‫من‬ ‫التصنيعية‬ ‫العملية‬ ‫مراحل‬ ‫من‬ ‫مرحلة‬ ‫كل‬ ‫يغطي‬
‫والعاملين‬ ‫الموظفين‬ ‫تدريب‬
‫أنظمة‬ ‫إدارة‬ ‫في‬ ‫الدوائية‬ ‫الصناعة‬ ‫شركات‬ ‫يساعد‬
G×P

3. cut costs
project
identify and
manage
hazards and
defects
enable effective
change
management in
GxP-compliant
pharmaceutical
project delivery
Reduce waste implement systemic
risk management

5. TRACEABILITY
 Is a process for ensuring that requirements are addressed and tracible to the
appropriate functional and design elements in the specifications and the
requirements can be traced to the appropriate verification.

6. GAMP 5 ACTIVITIES
 DQ : Design Qualification
 IQ : Installation Qualification
 OQ: Operational Qualification
 PQ: Performance Qualification

9. COMPUTERIZED SYSTEM CONSISTS OF:
 1. hardware
 2. software
 3. network
 4. operating procedures
 5. people

11. SCOPE OF THIS GAMP 5 TEMPLATE FOR
PHARMA VALIDATION & QUALITY MANAGEMENT:
 Scope of this GAMP 5 Template for Pharma Validation & Quality Management
 Quality Risk Assessment
 Quality Audit and CAPA Management
 FDA 21CFR11
 Requirements and Compliance Check

42. The challenges