In-Process Testing
In-process testing is an integral part of the routine check performed during production to ensure that the established product quality is met. The analysis is performed on samples from the manufacturing process to ensure it is being manufactured to specification.
To assess drug potency in samples collected from different stages of the bioprocess, bioassays developed to support this testing are usually distinct from routine product lot-release assays since their purpose is to detect unexpected changes in the samples from the process. A drug substance or final product that fails to meet in-process or final release specifications will be rejected for use.
At Svar Life Science, we offer the following services to support your production and process development activities:
- Potency testing per your standard operating procedures (GMP or non-GMP)
- Optimization and development of potency assays
Discuss your testing strategy with our expert team
Discuss your testing needs with our QC Team to ensure that the in-process testing is performed in accordance with internationally recognized harmonized standards such as ICH and USP. Contact us using the form below.
Contact Our QC Team
We would love to hear from you