SCOPE OF ACCREDITATION TO ISO/IEC 17025-2005 DHHS/FDA/ORA PACIFIC REGIONAL LABORATORY SOUTHWEST 19701 Fairchild Irvine, CA 92612 M. Jasmine Thompson Phone: 949 608 3520 CHEMICAL Valid to: April 30, 2016 Certificate Number: 2442.02 In recognition of the successful completion of the A2LA evaluation process (including an assessment of the laboratory's compliance with the A2LA Food Testing Program Requirements, containing the 2010 “AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses for Food and Pharmaceuticals”, accreditation is granted to this laboratory to perform the following tests using the associated technologies: Spectroscopy Ultraviolet/ Visible (UV/VIS) Fluorimetry Fourier Transform Infrared Spectroscopy (FTIR) Separation Technologies Gas Chromatography (GC) High Performance Liquid Chromatography (HPLC with UV (DAD and FL detection) GC/Mass Spectrometry (GC-MS) Liquid Chromatography/Mass Spectrometry (LC-MS/MS (TQ and ITD)) Thin Layer Chromatography (TLC) Wet Chemistry Titrimetry Electrochemical (pH) Entomology Extraneous Filth Microscope Miscellaneous Titration (including Karl Fischer) Organoleptic Leak Testing Using the following method references: Official Methods of analysis of the AOAC International, United States Pharmacopoeia (USP-NF), FDA Compliance Program Guides, Pesticide Analytical Manual (PAM), Journal of the Association of Official Analytical Chemist; FDA Laboratory Information Bulletins (LIB), Approved New Drug Applications, Abbreviated New Drug Applications, European and Japanese Pharmacopoeia, FIRMS “Methods” (proprietary drug company methods), Center for Veterinary Medicine Assignments, FDA Forensic Chemistry Center Methods (FCC). (A2LA Cert. No. 2442.02) 07/31/2014 Page 1 of 2 Routine Test Procedures: Test Method Test Identity Food Chemistry Histamine in Seafood (Seafood Decomposition) Nitrofuran Flouroquinolones Melamine Chemotherapeutics: Gentian Violet and Malachite Green Nitrofuran Flouroquinolones AOAC 977.13 LIB 4482 LIB 4408 LIB 4423 LIB 4395; CP 7304.018 LIB 4482 LIB 4408 Drug Chemistry Identification of Drug Products Water content (Karl Fischer) pH ED drugs USP 197, 201, 621, 736, 851; Firms methods* USP 921 USP 791 FCC TO28 (2002); LIB 4445 Pesticides by GC/MS in Foods / Feeds High Moisture Foods Fatty Foods Low Moisture Foods Pesticides by LC/MS in Foods/Feeds High Moisture Foods LIB: 3896, 4178, 4304, 4308; PAM 302 LIB: 4110, 4178, 4304, 4308; PAM I 302 E8 LIB: 3964, 4110, 4178, 4304, 4308 LIB 4465 Miscellaneous Organoleptic Filth / Entomology / Microscopy Animal Feed Microscopy/BSE Latex Glove Testing Condom Testing CP 7303.842, 7303.844 AOAC Chapter 16; LIB; MPM AOAC 964.07, 970.09; CVM Assignment VA 07-04; CP 71R844; LIB 4486 21 CFR Part 800.20 LIB 3970; CP 7124.21 Using the following method references: AOAC= AOAC International; Official Methods of Analysis of the AOAC International BAM = FDA Bacteriological Analytical Manual BSE=Bovine Spongiform Encephalopathy CFR= Code of Federal Regulations CP = FDA Compliance Program ED=erectile dysfunction LIB = FDA Laboratory Information Bulletin MPM= FDA Microanalytical Procedures Manual PAM = Pesticide Analytical Manual * Methods from regulated organizations (A2LA Cert. No. 2442.02) 07/31/2014 Page 2 of 2 A2LA has accredited DHHS/FDA/ORA PACIFIC REGIONAL LABORATORY SOUTHWEST Irvine, CA for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated 8 January 2009). Presented this 31st day of July 2014. _______________________ President & CEO For the Accreditation Council Certificate Number 2442.02 Valid to April 30, 2016 For the types of tests to which this accreditation applies, please refer to the laboratory’s Chemical Scope of Accreditation.
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