Method Transfer and Validation

Whether your quality control strategy utilizes in-house resources, your contract manufacturer, or a third party analytical testing laboratory, or all of the above, the effort to transfer and validate methods suitable for a commercial product is time consuming and management intensive. We can help! A partial list of analytical projects we have undertaken includes:

Development of strategy and approach to streamline method transfer or validation efforts
Development, oversight, and review of documents related to the comparability and validation efforts, including:
- Master Plans
- Development Lab characterization protocols and reports
- SOPs, batch records, and related GMP documents
Validation of methods for product release, in-process controls, cleaning, and raw materials testing
Management of reference standards and custom reagents
Specification Development
Risk assessments and gap analysis
Technical investigation of deviations, method failures, and out-of-specification results
Writing and review of documents for global regulatory submissions
Master Planning, scheduling and tracking of validation efforts
Validation of related equipment, computer systems and other automated systems
Hands-on assistance during method transfer and validation activities
Planning and performing equipment calibrations