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GMP in pharmaceutical processing and its implications for centrifuges Filtration & Separation, Volume 41, Issue 2, March

2004, Pages 20-23

Original Research Article

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Quality assurance for biopharmaceuticals: An overview of regulations, methods and problems Original Research Article Pharmaceutica Acta Helvetiae, Volume 71, Issue 6,December 1996, Pages 421-438

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Computer system validation: An overview of official requirements and standards

Original Research

Article
Pharmaceutica Acta Helvetiae, Volume 72, Issue 6, February 1998,Pages 317-325

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Quality assurance of computer systems what is needed to comply with ISO 9000, GMP, GLP, and GCP? Original Research Article Laboratory Automation & Information Management,Volume 31, Issue 1, September 1995, Pages 11-24 Siri H. Segalstad

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Operational measures to ensure the continued validation of computerised systems in regulated or accredited laboratories Original Research Article Laboratory Automation & Information Management,Volume 31, Issue 1, September 1995, Pages 25-34

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Vendor audits for computer systems: ISO 9000-3 approach Original Research Article Laboratory Automation & Information Management,Volume 32, Issue 1, May 1996, Pages 23-31

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4 - Good manufacturing practice Quality, 2002, Pages 57-92

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Approaches to the validation of spectrophotometers

Original Research Article

Analytical Spectroscopy Library, Volume 6, 1995, Pages 21-34

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A broader view of validation; the balance of compliance and science Original Research Article Laboratory Automation & Information Management,Volume 31, Issue 1, September 1995, Pages 35-42 http://www.sciencedirect.com/science/article/pii/1381141X9580013S? _fmt=high&_rdoc=1&_origin=article&_zone=related_art&md5=11d3ddc0dd6ac694c6e52b48673b 47f6 Original Research Article

Modern instrument design in assisting with compliance to regulatory standards Analytical Spectroscopy Library, Volume 6, 1995, Pages 205-221

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12 System validation: Pre-installation, IQ, OQ, andPQ

Separation Science and Technology, Volume 6, 2005, Pages 303-333

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Efficient and economic HPLC performance qualification

Original Research Article

Journal of Pharmaceutical and Biomedical Analysis, Volume 51, Issue 3, 5 February 2010, Pages 557-564

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Validation of the process control system of an automated large scale manufacturing plant

Research Article
Pharmaceutica Acta Helvetiae, Volume 72, Issue 6, February 1998,Pages 333-342

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9 Instrument qualification and software validation

Original Research Article

Separation Science and Technology, Volume 8, 2007, Pages 269-296

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Chapter 8 - Good Laboratory Practices and Current Good Manufacturing Practices Academia to Biotechnology, 2005, Pages 45-58 Jeffrey M. Gimble

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Automation and Validation of Information in Pharmaceutical ProcessingJoseph F. de Spautz (Editor), Drugs and the Pharmaceutical Sciences, Marcel Dekker; New York; Vol. 90, 1998, pp. 441; ISBN 0-8247-0119-4 European Journal of Pharmaceutics and Biopharmaceutics,Volume 51, Issue 1, January 2001, Page 86

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