As trusted advisors, we feel that it's critical that the appropriate measures are taken to ensure quality outcomes. NAMSA laboratories are registered with and inspected by the United States Food and Drug Administration (FDA) and Department of Agriculture (USDA). NAMSA's quality system complies with the following regulations:
- FDA 21 CFR 820
Quality System Regulation
- FDA 21 CFR 58
Good Laboratory Practice for Nonclinical Laboratory Studies
- FDA 21 CFR 210/211
Current Good Manufacturing Practice for Finished Pharmaceuticals
- FDA 21 CFR 11
Electronic Records; Electronic Signatures
- ISO 13485:2003
Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
- ISO 17025:2005
General Requirements for the Competence of Testing and Calibration Laboratories
Quality in Operations
NAMSA's quality policy is to deliver error free competitive products and services on time to our clients to meet or exceed their expectations. Laboratory operations are designed to meet the regulatory requirements cited above and this quality policy. Communication systems are discussed with clients to ensure access to critical staff and laboratory functions. To ensure client confidence, on-site audits by clients where NAMSA is deemed a critical vendor are available.
Good Laboratory Practices
Non-clinical safety studies submitted to the U.S. Food and Drug Administration (FDA) as part of an application to market specified products must be conducted according to Good Laboratory Practice Regulations (21CFR Part 58) "to assure the quality and integrity of the safety data." NAMSA test protocols outline the requirements for compliance under these regulations. Contact NAMSA personnel for more information about NAMSA's quality systems and circumstances for when GLP treatment is warranted.
