Through Barrier ID Testing and Sample Reduction Program to Address High Volume Raw Material Testing Requirements
100% ID testing for starting materials, such as that stated in PIC/S Annex 8, is one of the most important requirements to assure safety and efficacy of drug products for patients. However, this is also one of the most difficult GMP requirements due to the sheer number of samples requiring evaluation. One procedure to comply with this requirement is to take QC samples from all containers and to perform compendia ID tests. However, is this practical in terms of sampling contamination risk and cost?
This webinar will describe the practical procedures to deal with 100% ID testing requirements. One solution is through-barrier ID test technology, as skipping the sampling step can reduce the contamination risk. Another solution is a sample reduction program according to PIC/S Annex 8, helping reduce both man-hours and the contamination risk. The practical procedures that bring benefits for both patients and product manufacture will be discussed.
Date and Time: Thursday November 8 2018, 8:00 AM PDT, 11:00 AM EDT, 4:00 PM GMT, 5:00 PM CET
Koji Kimura, MBA
Manager of Quality Assurance, Astellas Institute for Regenerative Medicine (AIRM)
Key learning topics
- How to increase efficiency of raw materials ID testing
- How to meet increasingly strict regulatory requirements with through-barrier technologies
- How standard spectroscopic testing methods compare with SORS Raman technology