Abstract
Documentation is an essential component in a GMP environment. Without proper documentation, Justification of data generation and data interpretation cannot be obtained. The old expression “If it’s not Documented it’s not Done” is well suited in a GMP/Regulatory environment. Included in this chapter are templates for several of the important documents that must available in an Analytical Department. Those described herein are Sample Submission, Technical Reports, Reports of Analysis, and Training Records.
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© 2013 Springer Science+Business Media New York
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Catalano, T. (2013). Documentation. In: Essential Elements for a GMP Analytical Chemistry Department. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7642-9_6
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DOI: https://doi.org/10.1007/978-1-4614-7642-9_6
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Online ISBN: 978-1-4614-7642-9
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