ICH in Full Form = The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
These guidelines for the storing and studying of pharmaceutical products are followed and adhered to all over the world.
Purple Diamond Testing Capabilities per ICH Guidelines
- Stability of New Drug Substances and Product Lines. For this we place samples inside multiple different test chambers simulating many different environmental conditions.
- Photostability of New Drug Substances and Product Lines. For this we test the sensitivity the product has to light.
- Stability of New Dosage Forms. This is the testing of new dosage amounts, which can change over the course of a certain drug’s tenure.
- Designs for the Stability Testing of New Drug Substances and Products. This is the first step, except this process strictly uses prototyping throughout the design, testing, and engineering process.
- Analysis of Data. We compile all data produced over the tenure of the project.
There are many other things we do here at Purple Diamond relative to the ICH:
- Test For Impurities in New Pharmaceutical Products
- Provide Microbial Examinations of Non-Sterile products
- Join In Quality Risk Management Consultations
- Give Pharmaceutical Quality System Recommendations
- Pharmaceutical Products Lifecycle Management
- Provide On-Going Research and Development of Pharmaceutical Products
- Validate Stability Study and Storage Procedures
