Method Development Optimization and Validation
SGS provides you with extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning and bioanalytical testing.
To help you with pharmaceutical method development and validation processes, we offer development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes. This is conducted in compliance with the Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology and Validation of Analytical Procedures Methodology by the ICH (Q2A, Q2B) and FDA guidelines.
Once a method is validated, it may require transfer. Method transfer may involve comparative testing, co-validation between two sites (lab-to-lab), complete or partial revalidation and comprehensive documentation (transfer plan, protocol and report).
Why choose method development optimization and validation from SGS?
Whether we are the developing or the receiving laboratory, we can assist you with your method transfer requirements.
Our method development and validation services include:
- Bioanalytical assays
- Assay testing
- Testing for impurities
- Stability indicating methods
- Moisture content
- pH values
- Light stressing
- Microbial testing
- Particle size analysis
Trusted method development optimization and validation from a world-leading provider
As world leader in testing, inspection, verification and certification, we offer you extensive experience in pharmaceutical method development and validation.
Typical method validation will include the following tests:
- System suitability test
- Specificity (including forced degradation where applicable)
- Detection limit
- Quantitation limit
- Robustness (including stability)
To discuss your method development optimization and validation requirements, call us today.