Please enable JavaScript.
Coggle requires JavaScript to display documents.
Validation Management SOP Scope - Coggle Diagram
Validation Management SOP Scope
Analytical Methods
Analytical Method Validation
Analytical Method Verification
New products
Automatic Integration
Equipment/Computerised Systems
Validation Plan
IQ/OQ
SAT
PQ
FAT
VSR
DQ
RTM
URS
Process Validation
New products
Method validation
Check if equipment is qualified
Micro Requirements
PQ
Risk Assessment
Change Control
Microbiology Validation Requirements
Processes
Transfer Sanitisation
Environmental Qualification
Aseptic Process Simulation
Growth Promotion
Sterility
Bioburden Testing
Pre-filteration
Equipment and Facility
Cleaning and Disinfection
Smoke Visualisation
Cleanroom Requalification
At commisioning
Routinely
Pressure differentials across HEPAs
Filter Leak test on HEPAs
Air Flow through HEPAs
Will give air change rates per room
Pressure differentials within different rooms
Particle counts
Annex 1
Operators
Gowning
Handwashing
Aseptic Transfer
Broth Test
Temperature
Transport
Controlled Areas Temperature Mapping
Equipment
Heating Blocks
Utilities
Approach to Validation
Documentation
Risk Assessment
Deviations
Change Control
Terminology
Competency Assessment
Calibration
Qualification
Verification
Validation
Dose Calibrators
Accuracy
Gemoetry
Linearity
Constancy
Maintenance Program
Revalidation
Recallibration
Requalification
Ongoing Competency Assessments
Significant Changes to Process/Equipment
Actions required as per Annex 15
Risk Assessment
Change Control
Requalification/Revalidation
Verification Testing
Documentation
Continuous Monitoring and Post-Change Surveillance
Impact on Validated State
Identifying Signifcant Changes