Validation & Calibration Services
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