Bio/Technology
10, 870 - 872 (1992)
doi:10.1038/nbt0892-870
Up to Code: Validating a Chromatography SystemSanford Weinberg1, Janie Spelton1, Phillip Sax1
& Gail Sofer2
1Sanford Weinberg, Janie Spelton, and Philip Sax are with Weinberg Associates, Inc., an independent validation company in Boothwyn, PA.
2Gail Sofer is with Pharmacia BioProcess Technology AB in Piscataway, New Jersey. BioProcess System is a trademark of Pharmacia LKB.
REFERENCES
- U.S. Center for Drug and Biologies and Center for Devices and Radiological Health. 1987. Guidelines on General Principles of Process Validation (May).
- Goren, L.J. 1989. Computer system validation. II. Evaluating vendor software. Biopharm 2: 38−41.
- Kovach, S.A. 1990. Control systems project phases, including validation. Pharm. Eng. 10: 17−21.
- Berkland, R.D. 1991. Validatable software design. Pharm. Tech. 15: 160−165.
- Tetzlaff, R.F. 1992. GMP documentation requirements for automated systems. Pharm. Tech. 16: 60−72.
- Sofer, G.K. and Nystrom, L.E. 1991. Process Chromatography: A Guide to Validation. London: Academic.
- 21 CFR 210 and 211 (43 FR 544076, September 29, 1978).
- ISO 9000. 1987. International Standards for Quality Management, International Organization for Standardization.
- Weinberg, S.B. 1990. System Validation Standards. Debuque, Iowa: Kendall/Hunt Publishing.
- Johansson, H.M. Ostling, G. Sofer, H. Wahlstrom et al. 1988. Chromatographic equipment for large-scale protein and peptide purification. In Advances in Bio-technological Processes, Vol. 8. New York: Alan R. Liss. | ChemPort |
- Chapman, K.G. and Harris, J.R. 1989. Computer system validation−staying current. Biopharm 5: 30−39.
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