OS Diagram
Explanation
OS Diagram
Overall View
 OS Diagram
Engineering View
 OS Diagram
Construction View
 OS Diagram
Validation View
GMP CB
Home
Engineering
 Construction
 Validation
Engineering
 Construction
 Validation


GMP
Compliance Basis
Operating System Diagram...the Engineering view...
All Rights Reserved
GMP Compliance Basis
Project
Requirements
Project
Definition
Facilities
Equipment
Utilities
Schematic
Design
Enhanced
Design
Review-1
Preliminary
Design
Enhanced
Design
Review- 2
System
Impact
Assessment
Final
Engineering
Commissioning
Submittals
Qualification
Operation
Construction
URS- 1
URS- n
Requirements
Design
Requirements
Design
System
Review
Design
Requirements
Good Engineering Practice
with Change Control
Enhanced
Documentation
Engineering
Turnover
Package
Construction
with
Enhanced
Documentation

Standard
Construction
Practices
Commissioning
with
Qualification
Practices
Performance
Qualification
Trial Batch
Records
Draft
SOPs
Batch
Records
Final
SOPs
FRS-1
FRS-n
Deliverables
Design
Basis
Good Engineering Practice
Good Engineering Practice
No
Impact
Indirect
Impact
Direct
Impact
Enhanced
Design
Review- 3
Design
Basis
Deliverables
System
Review
Standard
Commissioning
Practices
Installation
Qualification
Operational
Qualification
Draft
SOPs
Process
Validation
Final
SOPs
Design
Design
Project
Definition
URS- 1
URS- n
Requirements
Design
Requirements
Design
System
Review
Design
Requirements
Good Engineering Practice
with Change Control
Enhanced
Documentation
Engineering
Turnover
Package
Construction
with
Enhanced
Documentation

Standard
Construction
Practices
Commissioning
with
Qualification
Practices
Performance
Qualification
Trial Batch
Records
Draft
SOPs
Batch
Records
Final
SOPs
FRS-1
FRS-n
Deliverables
Design
Basis
Good Engineering Practice
Good Engineering Practice
No
Impact
Indirect
Impact
Direct
Impact
Design
Basis
Deliverables
System
Review
Standard
Commissioning
Practices
Installation
Qualification
Operational
Qualification
Final
SOPs
Design
Design
Draft
SOPs
Project
Definition
URS- 1
URS- n
Requirements
Design
Requirements
Design
System
Review
Design
Requirements
Good Engineering Practice
with Change Control
Enhanced
Documentation
Engineering
Turnover
Package
Construction
with
Enhanced
Documentation

Standard
Construction
Practices
Commissioning
with
Qualification
Practices
Performance
Qualification
Trial Batch
Records
Draft
SOPs
Batch
Records
Final
SOPs
FRS-1
FRS-n
Deliverables
Design
Basis
Good Engineering Practice
Good Engineering Practice
No
Impact
Indirect
Impact
Direct
Impact
Design
Basis
Deliverables
System
Review
Standard
Commissioning
Practices
Installation
Qualification
Operational
Qualification
Final
SOPs
Design
Design
Draft
SOPs
Comments or feedback regarding this website? contact webmaster@gmpcompliancebasis.com
Copyright 2004-08
Industry Links
GMP Compliance Basis
All Rights Reserved
Future
Legal Disclaimer
About GMP CB
Home
Commissioning Plan
Qualification Plan
Compliance Master Plan
Design Phase
Commissioning Protocols
Qualification Protocols
GMP Compliance Documentation
Compliance Master Plan
Execution Phase