Lifecycle Validation in Biopharmaceutical Quality Control Analysis: v. 2: From Instrument Qualification and Method Validatin to Routine Use in a Biopharmaceutical QC Laboratory (Hardback)Iris Unterrieder (author)
Hardback 240 Pages / Published: 09/11/2010
- Coming soon
This book is a guide for quality control laboratories in pharmaceutical industry, and other labs using high performance liquid chromatography (HPLC). The book gives a biopharmaceutical industry point of view on the interpretation and implementation of the different guidelines and requirements for instrument qualification and analytical method validation. It overviews key topics like qualification process according to actual guidelines, method development with a focus on biological and protein sample analysis, method validation, change control, and instrument maintenance.
Publisher: John Wiley and Sons Ltd
Number of pages: 240
Dimensions: 250 x 150 mm
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