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 | ICH Stability Storage and Studies for Pharmaceutical Products
- 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
As always, Purple Diamond offers you the ability to either schedule an initial consultation, complimentary, OR you can book a facility tour and come on in and visit. Definitely feel free to stop in to the lab if you are close to the Lehigh Valley. The packaging and whole Purple Diamond team is here to assist you anyway that we can. The initial consultation can be either a phone call or a zoom call, whatever is more convenient for you. Reach out via the Contact Us page by either filling out the contact us form OR booking some time on the calendar below the contact form. Either way we will get back to you! Thank you so much for reading down this far and thank you for considering Purple Diamond as your dedicated testing, engineering, and design facility for all of your packaging needs. Contact us here.