NAMSA maintains the following:
Regulatory Requirements and Quality in Operations
- NAMSA is certified to ISO 13485:2003 and ISO 9001:2008, and is accredited to ISO 17025:2005.
- We 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).
- We operate with full accreditation by AAALAC International.
- We follow U.S. Department of Agriculture (USDA) regulations.
Protocols and Procedures
- All samples submitted to NAMSA are tested according to established written standard operating procedures, or specific protocols or study plans, as appropriate.
- Samples are assigned a sequential lab control number which is 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 facsimile, 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.
ISO 13485
http://www.tuvamerica.com
ISO Certification OH
ISO Certification CA
ISO 9001:2008
ISO Certification MN
ISO 17025
http://www.a2la.org/
ISO Certification OH — Biological
ISO Certification OH — Chemical
ISO Certification CA — Biological
ISO Certification CA — Chemical
Accreditation COFRAC - Lyon
U.S. FDA Establishment
http://www.fda.gov/
NAMSA is registered with the CDER and CBER divisions of the FDA. 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 as well as inspections by CDER under 21 CFR 211.
FDA Registrations
OH #1521876
CA #2020640
DEA Registration (Federal and State)
http://www.dea.gov/
DEA registration numbers are confidential.
Ohio Department of Health License for Radioactive Material
http://www.odh.state.oh.us/ License #03620880001
Ohio Environmental Protection Agency (EPA)
http://www.epa.state.oh.us/
Registration #87-G-00778
OH-EPA