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U.S. FDA Establishment
www.fda.gov
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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. |
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FDA Registration
OH # 1521876
CA # 2020640
Association for Assessment and Accreditation
of Laboratory Animal Care International (AAALAC)
www.aaalac.org
OH Certificate #: 000457
CA Certificate #: 000458
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DEA Registration (Federal and State)
Reg. #: Confidential
www.dea.gov
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Institutional Animal Care and Use Committee (IACUC)
www.iacuc.org
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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.
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ISO Certification OH