cGMP implementation
Validation
Self inspection
Market complaints
Vendor evaluation
Training
Document review
Process non-conformity review and approval
Investigation
Product recall
Document control / Change control
Regulatory requirements
Deviations review and approval
Qualification of equipment’s
Final batch release
Stability assessment and approval
GMP Monitoring |
GLP implementation
Sampling
Testing
Approval/rejection as per the test status.
Method validation
Specifications
Laboratory Investigation
Analyst training
Water testing
Area monitoring
Environment monitoring
Microbiological testing
Stability studies
Impurity profile
Degradation studies
Control samples |