ISO 13485
http://www.tuvamerica.com
ISO Certification OH
ISO Certification CA
ISO Certification GA
ISO 17025
http://www.a2la.org
ISO Certification OH - Biological
ISO Certification OH - Chemical
ISO Certification CA - Biological
ISO Certification CA - Chemical
U.S. FDA Establishment
http://www.fda.gov
NAMSA is registered with the CDER and CBER divisions of the FDA. The CDRH branch of the FDA does not allow for registration of contract laboratories and contract manufacturers. The FDA inspects contract laboratories as an extension of a manufacturer's quality systems. NAMSA has been involved with focused inspections by CDRH under 21 CFR Part 820.
FDA Registration
OH # 1521876
CA # 2020640
U.S. Department of Agriculture
www.usda.gov
OH Certificate #: 31-R-0068
CA Certificate #: 93-R-0145
USDA Certificate
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)
http://www.aaalac.org
OH Certificate #: 000457
CA Certificate #: 000458
DEA Registration (Federal and State)
Reg.#: Confidential
http://www.dea.gov
Institutional Animal Care and Use Committee
(IACUC)
http://www.iacuc.org
Ohio Department of Health License for Radioactive Material
http://www.odh.state.oh.us
License #: 03620880001
Radioactive Material License
Ohio Environmental Protection Agency (EPA)
http://www.epa.state.oh.us
Reg #: 87-G-00778
OH-EPA
Regulatory Requirements and quality in operations
- Certified to ISO 13485:2003
- Accredited to ISO 17025:2005
- Perform testing according to the requirements defined in 21 CFR 58, 820 (U.S. Food and Drug Administration, Good Laboratory Practices and Quality System regulations)
- Operate with full accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)
- Follow U.S. Department of Agriculture (USDA) regulations
- Submit all testing requiring laboratory animals to an IACUC (Institutional Animal Care and Use Committee).
Protocols and Procedures
- All samples submitted to NAMSA are tested according to established, written standard operating procedures, specific protocols or study plans, as appropriate.
- Samples are assigned a sequential lab control number used on all associated raw data sheets, log books, laboratory notebooks and NAMSA Laboratory Reports.
- Traceability and test status are maintained and tracked through these control numbers and systems of physical segregation.
- Strict laboratory quality guidelines are followed to assure valid data.
- Each step of laboratory operations is carefully controlled to assure accurate and reliable testing programs.
- Original data are recorded in ink on signed, dated record forms or notebooks and are approved by supervisory personnel.
- Upon completion of a study, all data are stored in a central file in permanent archives.
- Clients are promptly notified of adverse test results by telephone or fasimile without charge.
- Fees listed for each test include:
- One copy of the final report to a designated individual,
- One copy of the final report and supporting data to NAMSA archives,
- One invoice to a designated individual or department.
Auditing and Review
- NAMSA has a robust internal audit program including process based audits, facility audits, and testing based audits from an independent quality assurance unit.
- Members of NAMSA's staff are selected and trained for specific job functions.
- Laboratory equipment is entered in a central calibration and maintenance program for routine calibration.
- Laboratory functions are audited by NAMSA's quality assurance department staff.
- Independent and regulatory auditors routinely visit NAMSA to verify compliance to quality system standards.
- Performance of routine tests is monitored by periodic check samples and statistical process control.
