Review of validation documents
Environmental monitoring plan
Standard Operating Procedures
Change controls
Deviations
Batch Processing Records
Specifications
MANUFACTURING
Documentation
Documentation Review
Equipment Qualification
Acceptance criteria review
Process Validation
PQ Philosophy
Protocol Review
Cleaning Validation
System Validation
PQ Water Systems
PQ HVAC
Media Fills
Clean Room Validations
Risk Assessment Review
Manufacturing Assistance
Technology Transfer Assistance
Protocol and Acceptance Criteria Review
Equipment Suitability
Batch Record Review
Report Review
Technology Licensing Assistance
Value analysis
Intellectual property assessment
Negotiations
Continuous Improvement Implementation
Target definition
Performance assessment
Project definition and follow-up
Capital Usage Optimization
Switch to multi-products operations
Automation versus manpower
Scale -up and/or bottleneck elimination
