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Links

GMP links omkring: måleteknik, metrologi, kalibrering, standarder mv.....

METROLOGY LINKS

1. American Association for Laboratory Accreditation

2. American National Standards Institute

3. DEN DANSKE AKKREDITERINGSFOND

4. International Organization for Standardization

5. National Conference of Standards Laboratories (NCSL)

6. National Institute of Standards and Technolog

7. Cal Lab Magazine

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FDA LINKS

1. FDA Home Page

2. FDA Modernization Act of 1997 (FDAMA)

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ANDRE LINKS

    1.     American Society for Quality (ASQ)

    2.     American Society of Mechanical Engineers

    3.     DIA —Drug Information Association

    4.     FM Global Technologies LLC

    5.     International Society for Pharmaceutical Engineering (ISPE)

    6.     Quality Magazine

    7.     PDA —Parenteral Drug Association

    8.     U.S. Pharmacopeia

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FDA

    1.     820.72 Access Data FDA

    2.     Regulatory Requirements for Medical Device Calibration Programs

    3.     Measure for Measure: Where Does It Say That? – ASQ

    4.     FDA GMP 820.60/61

    5.     Validation and Calibration Definitions and Terminology

    6.     Pay Close Attention To Equipment Calibration Certificates, FDA Says

    7.     GMP 11 Good Measurement Practice for Assignment and … – NIST

    8.     GMP-compliant Maintenance & Calibration

    9.     PTS – GMP Compliant Calibration Programs

    10.   Tutorial – 21 CFR Part 11 – Electronic Records/Electronic Signatures

    11.   Process Validation: General Principles and Practices

    12.   Inspections – Food and Drug Administration

    13.   Process Validation: Practical Aspects of the “New” FDA Guidance