Abstract
This paper provides a general introduction to the methodology employed by the pharmaceutical industry to assure confidence in software. This methodology has become known within the industry as Good Automated Manufacturing Practice (GAMP).
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References
‘Interview with Richard Klug’, Pharmaceutical Technology, 1994. [At the time this article was written Richard Klug was the Foreign Inspection Programme Director at the United States Food & Drug Administration].
Clark, S., ‘Computer System Validation: An Investigator’s View’, Pharma-ceutical Technology, 1988. [At the time this article was written Sam Clark was a United States FDA Investigator].
Tetzlaff, R., ‘GMP Documentation Requirements for Automated Systems,’ Pharmaceutical Technology, 1992. [At the time this article was written Ron Tetzlaff was a United States FDA Investigator].
Trill, A.J., ‘Computerised Systems and GMP A UK Perspective’, Parts 1,2 and 3, Pharmaceutical Technology, 1993. [At the time this article was written Tony Trill was a United Kingdom MCA Investigator].
United States Food & Drug Administration, Guide to Inspection of Computerised Systems in Drug Processing’ and ‘Software Development Activities’, Technical Reports, Reference Materials and Training Aids for Investigators.
United States Parenteral Drug Association, ‘Validation of Computer-Related Systems,’ Journal of Pharmaceutical Science and Technology, 1995.
United Kingdom Pharmaceutical Industry Computer Systems Validation FORUM, ‘Validation of Automation Systems in Pharmaceutical Manu-facture’, (second draft 1994), Feb 1995.
Wingate, G.A.S., ‘Computer Systems Validation: A Historical Perspective,’ Pharmaceutical Engineering, Vol. 15, No. 4, 1995.
FDA, ‘General Principles of Process Validation,’ 1987.
Hunt, J., Lucas, P.R., & Wingate, G.A.S., ‘FRESCO — An Investigation into a Framework for the Assessment of Safety-Critical Systems,’ DTI Safety-Critical Systems Symposium (SSS ’95), Brighton, 1995.
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© 1997 Springer-Verlag London Limited
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Wingate, G., Smith, M., Lucas, P. (1997). Assuring Confidence in Pharmaceutical Software. In: Shaw, R. (eds) Safety and Reliability of Software Based Systems. Springer, London. https://doi.org/10.1007/978-1-4471-0921-1_7
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DOI: https://doi.org/10.1007/978-1-4471-0921-1_7
Publisher Name: Springer, London
Print ISBN: 978-3-540-76034-4
Online ISBN: 978-1-4471-0921-1
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