Quality Control for Production of Biologics

Expertise for Methods Qualification & Validation

Quality Control at Novasep – Our Offering

Methods Qualification / Validation

Novasep has great expertise in validating Quality Control analytical methods for raw materials and QC release testing. Our analytical method validation activities are performed in compliance with ICH Q2 (R1) guidelines, FDA and European Medicines Agency (EMEA) requirements.

Depending on the development stage of the project, we suggest a qualification or validation of the QC analytical tests used for the release of raw materials and/or release of the production steps, intermediates products,  or final products.  Qualified or validated methods can be transferred back to the client.

We can also organise transfer of an already validated analytical method to our QC laboratory using our specific procedure

Stability testing

Our services

• Protocol design and elaboration
• Development and validation of stability methods
• Long term and accelerated stability studies
• Sample management and storage
• Full ICH Compliant stability studies

Either as a developing or as a receiving laboratory, we can assist you to achieve successful transfer of the validated method!

Download our brochures for biologics manufacturing.

For any question on Novasep's manufacturing services and equipment for biologics, please contact us.