SGS provides you with extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning and bioanalytical testing.
Search within Method Development and Validation
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).
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:
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:
To discuss your method development optimization and validation requirements, call us today.
2nd Floor Alegria Office Building. 2229 Chino Roces Avenue,
1223,
Makati, Metro Manila, Philippines
