Quality Assurance and Regulatory Compliance
Blue Stream Laboratories is a progressively-compliant cGMP organization. Our aggressive growth is not only in innovative technologies, but also in comprehensive quality systems and structures. Our highly-trained staff is given the authority and responsibility to manage and enforce quality systems to the highest level.
Essential to the provision of compliant services is a comprehensive understanding of the evolving regulatory environment and in-house systems that assure compliance with governing regulatory bodies. We understand the agencies' requirements, and our systems are designed to provide a testing environment that will satisfy our clients' phase-specific quality compliance demands.
Our commitment to compliance is as integral to our success, and that of our clients, as our commitment to innovative science. Blue Stream Laboratories provides:
- Professional experience and prospective compliance with the guidelines from FDA and ICH regulatory agencies ensure that our testing programs, from raw material release testing to stability program management to commercial drug product release, are consistent with current industry interpretation
- Assays which comply with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP), and 21 CFR specific requirements
- A facility which is available for client QA audits
- Progressive internal validation programs for in-house analytical, immunological, and biological methods
- Client and/or product-specific analytical assays used for stability and release of clinical materials
- cGMP-compliant (21 CFR Part 210,211,610) testing that is consistent with global regulatory requirements for materials used in therapeutic and in vivo diagnostics
