Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

Andrews, John

Paperback

Medical ReferenceChemistry

ISBN10: 0367392380
ISBN13: 9780367392383
Publisher: Crc Pr Inc
Published: Oct 7 2019
Pages: 572
Weight: 1.70
Height: 1.30 Width: 6.10 Depth: 9.20
Language: English
This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential core task when establishing and maintaining compliance with global regulatory authorities, such as the FDA and the MHRA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.

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