Method Development, Testing and Validation
Method Development, Testing and Validation
Analytical Method Development, Validation, Stability and Contract Analytical Testing Services
Pillar5’s Analytical and Microbiological Laboratories provide the following services on manufactured products:
- Analytical Method Development, Optimization, and Validation according to the ICH Guidelines
- Raw material, packaging component, chemical intermediate and finished product testing services:
- Analytical capabilities include: HPLC, GC, TLC, dissolution, UV-Vis, IR and many more
- Wet chemical analysis
- Compendia testing such as USP, EP and JP requirements
- USP dissolution testing
- Analytical capabilities include: HPLC, GC, TLC, dissolution, UV-Vis, IR and many more
- Microbiological testing of pharmaceutical, biotech, nutraceutical, natural health, and consumer products:
- Microbial limits testing to meet USP and EP requirements
- Preservative effectiveness testing
- Cleaning validation and environmental monitoring
- Potable and purified water testing
- Sterility testing
- Atomic absorption
- Stability testing required to support finished packaged and bulk product stability programs:
- Stability studies and testing as per ICH guidelines
- Full stability data evaluation, including statistical evaluation of quantitative data
- Report writing and data compilation for technical progress reporting, GMP reviews and for submission-ready regulatory reports and modules
- Consulting on stability requirements for product development and post approval changes and variations