Quality

Quality Program

The Quality Management System has been established to standardize the quality practices employed to meet the mission, vision and quality objectives of ARL Bio Pharma.

It contains all of the requirements that testing laboratories must meet to demonstrate they operate a Quality Management System, are technically competent, and are able to generate technically valid results.  The Quality System is accredited to ISO 17025:2005 and follows various requirements established by the FDA, ICH and USP.

ARL Bio Pharma is committed to providing accurate and timely data to our customers and maintaining an organizational culture that promotes quality first, continuous improvement, and fosters personal and professional growth.

Our Quality Programs Include:

  • Audits – Accreditation, Regulatory and Internal
  • CAPA – Corrective and Preventive Action
  • Change Control
  • Complaints – Tracking, Review and CAPA
  • Deviation – Impact Assessment and Corrective Action
  • Document Control – Review and approval of all SOPs
  • Ethics, Conflict of Interest & Data Integrity
  • Instrument Calibration / IQ/OQ/PQ – External / Internal QC, EMS and Backup Power
  • Proficiency – Blind External PT Program
  • Quality Agreements – Transparency
  • Records Retention – Electronic Archive Storage & Offsite Data Center
  • Supplier Qualification – Paper Audits
  • Test Methods – Validation and QC (System Suit, QCS, Positive / Negative Controls)
  • Traceability – Standards & Test Data Traceability
  • Training – Competency Assessment and Ongoing CE
     

Our Credentials Include:

  • FDA (Food and Drug Administration) FEI 3003644883 – registered and inspected as an analytical (chemical and microbial analysis) laboratory.
  • DEA (Drug Enforcement Administration) RA0230603 – registered to handle schedule I-V drugs.
  • EPA (Environmental Protection Agency) / Ok DEQ (Dept. of Environmental Quality) OKR000020339 – registered and inspected as a small quantity generator.
  • ISO 17025:2005 via A2LA Cert No. 2992.01 – accredited and inspected as a chemical and microbial testing laboratory.
  • OBNDD (Oklahoma Bureau of Narcotics and Dangerous Drugs) 24175 – registered to handle schedule I-V drugs.
  • Oklahoma State Board of Pharmacy 1-W-1291 – Registered and inspected as a drug wholesaler.
             

ARL Bio Pharma is registered with the FDA and is an accredited laboratory.  However, this registration and accreditation should not imply that all worked performed at ARL falls under cGMP regulations and/or the scope accreditation. cGMP services are provided when requested and should be outlined in a scope of work associated with the quotation.  Accredited tests are listed on our scope of accreditation which can be found by clicking on the view certifications PDF.  Please contact us if you need cGMP services.

ARL makes no representation regarding the release of your product.  The test data supplied in and of itself is not sufficient to a make a decision on the release of pharmaceutical products for distribution.  Reported results only relate to the sample that was tested.

All services provided will adhere to ARL Bio Pharma’s terms and conditions.

If you have any questions please contact Tommy Means - tmeans@arlok.com or call (800) 393-1595.