Method Development & Validation

Method Development & Validation
Product Description

SGS life science 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 nonproprietary test methods and manufacturing processes in compliance with the ICH Q2 (R1) guideline “Validation of Analytical Procedures: Text and Methodology” 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 is the developing or the receiving laboratory, we can assist you with your method transfer requirements.

Method Development

- Identification
- Assay testing
- Dissolution
- Particle size distribution
- Testing for impurities
- Stability indicating methods
  - Humidity/temperature
  - Temperature
  - pH variation
  - Oxidative and reductive stress
  - Light stressing
  - Microbial testing

Validation

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

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SGS North America Inc.

  • US
  • 2015
    On CPHI since
View company profile
Sales Markets
Show more Show less

SGS North America Inc.

  • US
  • 2015
    On CPHI since
View company profile

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