Professional Documents
Culture Documents
Patient Safety
Product Quality
Data Integrity
IT
Labs
Manufacturing
6 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma
GAMP Document Structure
Non-configurable
URS
Single test phase
Verify …
Requirements
Functionality
Configuration
20 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma
Category 4 –Example
Identity
Specify
Verify
CQAs/CPPs (Crital Quality Attributes, Critical Process Parameters)
28 GAMP 5 - Good Automated Manufacturing Practices Aurobindo Pharma
Life cycle Approach within a QMS
Risk
Complexity
Supplier
Planning
Specification, configuration, and coding
verification
Reporting and release
35 Aurobindo Pharma
GAMP 5 - Good Automated Manufacturing Practices
Computer system Validation Framework
Activities
Responsibilities
Procedures
Timelines
• Handover
Project Team
Process Owner
System Owner
SMEs
38
Operational user Aurobindo Pharma
GAMP 5 - Good Automated Manufacturing Practices
Science Based Quality Risk Management
Assessment
Control
Communication
Review