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RSC Chromatography Monographs
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
By
Robert McDowall
Robert McDowall
Director, R.D.McDowall Ltd
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Hardback ISBN:
978-1-84973-662-6
PDF ISBN:
978-1-78262-407-3
EPUB ISBN:
978-1-78262-980-1
Special Collection:
2016 ebook collection
No. of Pages:
733
Published online:
23 Nov 2016
Published in print:
25 Nov 2016
Book Chapter
CHAPTER 4: Applicable GXP Regulations and Guidance for CSV
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Page range:
74 - 146
Citation
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 74-146.
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Understanding and interpreting the GXP regulations that a chromatography data system operates under is crucial to ensuring that the validation work is correct and meets the spirit and intent of the law. Where regulations are vague regulatory agencies often issue guidance, as do scientific societies and industry bodies, to help interpret the regulations.
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