Analytical Research Laboratories (ARL) follows current
Good Manufacturing Practices (cGMP) as established by
the FDA in CFRs 210 and 211, Good Laboratory Practice
(GLP) established by the FDA in CFR part 58 and USP monographs/general chapters and ICH guidelines as applicable to our customer requirements.
ARL is accredited to the ISO 17025:2005 standard that outlines general requirements for the competence of testing and calibration laboratories by the American Association of Laboratory Accreditation (A2LA). 
Quality Assurance &
Quality Control
Quality Assurance (QA) is an independent monitoring
function of the operations, reporting directly to the
President. Quality Control (QC) is the function performed
during the tests to monitor precision, accuracy, and
other analytical testing criteria. QC is performed by
the analysts as they are performing the tests.
QA Program
ARL has a QA Manual and a formal QA Program in compliance
with ISO 17025: 2005, FDA GMP / GLP regulations, USP monographs/general chapters and ICH guidelines. The
QA program consists of a set of standardized systems that cover the following: Test Methodology, Traceability, Measurement of Uncertainty, Quality Control, Training, Competency, Proficiency, Internal Audits, CAPA, Instrument Qualification, Supplier Qualification, Documentation Control, Change Control, Customer Complaints, Method Validation, Out of Specification (OOS) and Records Retention.
 Laboratory Accreditation
ARL is accredited to the ISO 17025:2005 standard that outlines general requirements for the competence of testing and calibration laboratories by The American Association of Laboratory Accreditation (A2LA). ISO/IEC 17025:2005 is the most widely used laboratory standard for testing and calibration laboratories and is internationally recognized and accepted world-wide. It contains all of the requirements that testing laboratories must meet if they wish to demonstrate that they operate a Quality Management System, are technically competent, and are able to generate technically valid results.
FDA Registration and Audit Status:
Click on the link below to be directed to the FDA's website for Drug Firm Annual Registration Status Query and then type in ARL BioPharma.
http://www.fda.gov/cder/dfars/docs/querydrls.htm
ARL's last FDA Audit was February 2010; the three day audit resulted in no 483's.
For more information on ARL's Quality contact:
Quality Director, Tommy Means - tmeans@arlok.com
or call (800) 393-1595
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