Blue Stream provides comprehensive, cGMP Lot Release Testing activities for both biologic and small molecule drug products. Our Quality Compliance and Quality Assurance programs are integrated and mature, enabling use for both cGMP Stability and Clinical Lot Release Testing programs.
Blue Stream provides full laboratory and documentation support for cGMP Clinical Lot Release Testing programs. Our on-site QA department has many years of experience managing quality systems, documentation, and personnel through their tenure in several pharmaceutical and biotech CROs. We welcome quality audits of our facility prior to the initiation of any cGMP program. Blue Stream takes utmost care in maintaining our compliance structure, and in the management of our cGMP Clinical Lot Release Testing programs:
- Use of Qualified and/or ICH Validated Methods
- On-site Quality Assurance and Regulatory Compliance
- Strict coordination with Sponsor to meet Clinical timelines
- cGMP Sample Tracking and Documentation
- QA-audited Laboratory Report
- IND/BLA Filing Assistance
Blue Stream also provides GLP bioanalytical clinical sample analysis services in support of clinical trials. These GLP programs are also prefaced by the development, transfer, qualification, and/or ICH Validation of the bioanalytical method used in the GLP study: LC/MS, ELISA, Chromatographic, etc. ICH Validated Methods are necessary for a GLP clinical sample testing program.