Current Good Manufacturing Practice regulations (cGMPs) are used by biotechnology, pharmaceutical, medical device, and veterinary drug companies to guide the manufacture and testing of human and animal therapeutic products. The U.S. Food and Drug Administration (FDA) has issued these regulations as the minimum requirements to assure control of the entire clinical and commercial production process, and to ultimately assure product identity, purity, and efficacy.
Blue Stream Laboratories is a cGMP compliant organization. Our corporate identity and success is not only dependent on our use of innovative technologies, but also in comprehensive Quality Assurance systems and structures. Our highly-trained Quality Assurance staff is given the authority and responsibility to manage and enforce our quality systems to the highest level.
Essential to the provision of cGMP compliant services is a comprehensive understanding of the evolving regulatory environment and appropriately responsive Quality Assurance systems. We understand the agencies' requirements, and our Quality Assurance systems are designed to provide a cGMP testing environment that will satisfy our clients' phase-specific quality compliance demands.
Our commitment to Regulatory Compliance is integral to our success. Blue Stream Laboratories provides:
- Professional experience and prospective compliance with the guidelines from FDA and ICH regulatory agencies which 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 requirements
- A facility which is available for client Quality Assurance (QA) audits
- Progressive internal validation programs for in-house analytical, immunological, and biological methods
- Client- and/or product-specific analytical assays used for cGMP 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 diagnostic applications
- Successful FDA Audits for Commercial Product Testing
- Successful Product and Program Specific QP Audits
Blue Stream has documented:
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