- Validation Services include:
- Master Planning
- Equipment and utility systems
- Computer systems and automated manufacturing systems
- Process validation for active pharmaceutical ingredients (API) and final dosage forms
- Analytical methods for product release, cleaning, and raw materials
Cleaning
- Product characterization and due diligence
- Calibration Services include:
- Calibration for temperature, timing, pressure and vacuum
- Temperature mapping
- Master Planning
- Scheduling and tracking
- Reference standard calibration
- Protocol and SOP generation and execution
- Individual and Project Summary Reports
- We also offer a turn-key approach to process validation, including:
- Defining the project scope and budget
- Staffing the project
- Generating protocols
- Interfacing with development and manufacturing on protocol execution
- Collecting data
- Generating reports
|
