SGS’ Life Science Services laboratories have extensive knowledge and expertise in developing and validating methods for raw materials, API’s, finished products and cleaning validation.

SGS offers development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes 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, Report). Whether SGS’ Life Science Services is the developing or the receiving laboratory, SGS can assist you with your method transfer requirements.”

Method Development Services:

• Identification
• Assay testing
• Testing for impurities
• Stability Indicating Methods
  • Humidity/temperature
  • pH values
  • Oxidative and reductive stress
  • Light stressing
• Microbial Testing

Method Validation:

• Accuracy
• Precision
  • Repeatability
  • Intermediate precision
  • Reproducibility
• Specificity
• Detection limit
• Quantitation limit
• Linearity
• Range
• Robustness
• System suitability test