Purpose and Mission
Bionique® Testing Laboratories, Inc. will provide to all clients the best possible mycoplasmal testing products and services to meet each client's individual quality standards. We will continue to be recognized as a global leader in mycoplasmal testing.
Bionique® Testing Laboratories, Inc. supports the following set of core values:
- Commitment to excellence in quality mycoplasma products and services.
- Commitment to meeting our customer's needs for mycoplasma testing, quality assurance and regulatory compliance.
- Commitment to continuous improvement and research in emerging methods and technology for mycoplasma detection.
- Commitment to the highest professional and ethical standards.
- Commitment to climate of trust and respect with all clients, suppliers, and regulatory authorities.
- Commitment to sustainable and profitable growth.
- Commitment to operating responsibly within the Adirondack Park.
Bionique® Testing Laboratories welcomes client audits. We recognize the role we serve as an extension of your manufacturing processes and quality control programs. We welcome the opportunity to demonstrate to you - the expertise and experience of our staff, facilities and quality systems.
All client information including sample receipt, raw data and final reports are treated in strict confidential manner. When requested, Bionique® Testing Laboratories will cooperate with individual clients to generate contractual service, confidentiality or quality agreements.
All clients can be assured that we adhere to the highest standards for Quality Assurance and Quality Control activities. We are a cGMP (Current Good Manufacturing Practices) facility operating in accordance with the Code of Federal Regulations (CFR) 21 parts 210 and 211.
Bionique® Testing Laboratories has the fastest possible turn around time for reporting in the industry. Clients receive written hard copies of all test results via first class mail provided by the United States Postal Service. If requested, final reports can also be provided by fax. Overnight courier service can also be arranged at the client's request and expense.
A Final Report package is prepared and assembled on the day that testing is completed. A Quality Assurance Report accompanies the Final Reports for the following GMP services: Cat. #: M-250, M-300, M-350, M-700, & M-800, M-1400, M-1500. Raw data and reports are archived and maintained by the Quality Assurance Department for a minimum of fifteen (15) years.