JF&A Laboratory Instrument Validation Services IOMPQ Development and Execution Services Custom Designed for your Laboratory to Meet cGMP Compliance

Overview of cGMP Services

Implementation of Instrument IOMPQ Programs for  Laboratories. Compliance is assured.  All test Data is Traceable to NIST Mixed Vendor, Older Technology is covered by JF&A JF&A execution or Training and Certfication of your staff for Execution Chromatographs and Spectrophotometers a speciality Ask about other Labopratory  Instrument Systems. Validation  Experience with a Analytical Instruments   Very cost effective over vendor IOPMQ Services. On site Execution of Protocols. Custom desgined for your QA compliance program. Audit Defense is provided Mixed Vendor and Older Technology serviced JF&A can bring in the Expertise you need. No lab to small or to large for our associates Experts in Process Validation, Methods Validation,  Laboratory Robotics and Laboratory Computer Systems JF&A has the connections in the Industry to meet your needs. Major companies use JF&A We Validate the system as you use it.

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Validation Services from JF&A We establish custom  Laboratory Instrument protocols of specific procedures and documentation to verify installation, operation, maintenance, and performance to meet compliance with current cGMP/GLP guidelines. JF&A will Interface with other Client Laboratory consultants to Validate the complete facility.                            References for the JF&A Validation Program 21 CFR  1-99 Subpart D:, “Part 58.63: Maintenance and Calibration of       Equipment,” 1994, FDA, NAARA. 21 CFR 200-299 “Part 211.94: Laboratory Records”, 1994,  FDA, NAARA. ASTM E682-92 “Standard Practice for Liquid Chromatography Terms and       Relationships,” 1994, 14.02, pp.411-418. ASTM E685-93  “Standard Practice for Testing Fixed Wavelength Photometric      Detectors Used in Liquid Chromatography,” 1994, 14.02,   pp.419-425. USP XXII  Physical Test 621: “Chromatography,” 1994 U.S. Pharmacopeia,    1558-1568 “Waters HPLC Systems Verification Workbook,” Rev.0, 1994, Millipore Corporation, Milford, MA. Document number 500-04TP Ludwig Huber, “Good Laboratory Practice,” 1993, Hewlett-Packard Corp.    publication number 12-5091-6259E. G. Maldner,  “Requirements and Tests for HPLC Apparatus and  Methods in Pharmaceutical Quality Control “, 1989 . Chromatographia, 28,85-88, (Bayer AG, Wuppertal,  FRG) D. Parriott, “Performance Verification testing of High Performance Liquid Chromatography Equipment,” 1994 LC-GC, Magazine of Separation Science, 12(2),132-139, (Pfizer Inc. Parsippany, N.J.) D.E. Wiggens, “System Suitability in an Optimized HPLC System,”  Journal of Liquid Chromatography, 14 (16&17),1991 3045-3060  (Schering Plough Inc, Memphis ,TN)

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Experts to Serve Your Laboratory Validation Needs

JF&A has been associated with Randy Estes  since 1990. Randy  founded Laboratory Validation Services in 1999.  LVS provides expert validation services for Laboratory Robotic Systems, Data Acquisition Systems, LIMs systems, and Computer Software.  JF&A and LVS worked together at major Pharmaceutical and Biomedical Companies to assist them with their lab validation requirements. JF&A can bring the resources you need to do the job quickly and cost effectively. Click the photo to visit LVS.

If you use Empower Data software, JF&A has experts who can develop your methods and teach your staff how to use this powerful chromatography package

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