Manufacturing Process
Parenteral Preparation Control
Clean Room Practice
- Gowning
-Traffic Flows
-Access Control
-Sanitization
-Monitoring
Documentation
- Controlled
- Consistent
- Timely
Procedure
- Documented
- Controlled
- Followes Exactly As Written
Change Over
- Cleaning
- Proof of training before Completing Procedure
Validation
- Equipment
- Processes
- Environment
Tracebility
-RM
- Components
- Product Change
- Change Control
Clean Room Practice
- Gowning
-Traffic Flows
-Access Control
-Sanitization
-Monitoring
Documentation
- Controlled
- Consistent
- Timely
Procedure
- Documented
- Controlled
- Followes Exactly As Written
Change Over
- Cleaning
- Proof of training before Completing Procedure
Validation
- Equipment
- Processes
- Environment
Tracebility
-RM
- Components
- Product Change
- Change Control
Manufacturing Process
1
Planning
1
2
Scheduling
-Equipment & Facility
- Documentation
- Personal
2
3
Manufacturing Requirement
3
4
Bulk Analysis
4
5
Sterilization
5
6
QC Analysis
6
7
Visual Inspection
7
8
Finished Product
8
9
Labeling & Packaging
9
10
Warehouse
10
11
Dispatch
11
