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 9001:2000 and FDA GMP / GLP regulations. The QA program consists of a set of standard operating procedures that cover the following QA Systems; Internal Audits, CAPA, Training / Proficiency, Instrument Operation, Maintenance and Qualification, Supplier Qualification, Documentation & Form Control, Customer Complaints, Change Control, Method Validation, Out Of Specification (OOS), & Records Retention.

Regulatory Statement
While the Code of Federal Regulations (CFR) part 58 Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) and the CFR part 210 & 211 current Good Manufacturing Practice (cGMP) as written by the Food and Drug Administration (FDA) refer to specific regulated activities in support of non clinical laboratory studies and the manufacture of pharmaceutical products, ARL follows many of the GLP part 58, and GMP part 210 & 211 guidelines as standard procedure as applicable to our customer requirements.

Audits
ARL's last FDA Audit was August 2007, the three day audit resulted in no 483's.

Drug Firm Annual Registration 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 Analytical Research Laboratories.
http://www.fda.gov/cder/dfars/docs/querydrls.htm