Method validation requirements and approaches in biotechnology

LC GC: Liquid Chromatography, Gas Chromatography

Volumn 16, Issue 3, 1998, Pages 258-263

  Krull, Ira ^a   Swartz, Michael ^b  

^a NORTHEASTERN UNIVERSITY   (United States)

^b WATERS CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0344812671     PISSN: 08889090     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (11)

1. U.S. Pharmacopeia 23/National Formulary 18 (United States Pharmacopeial Convention, Inc., Rockville, Maryland, 1995), chapter 〈1225〉, pp. 1982-1984.
2. I.S. Krull and M.E. Swartz, LC•GC 15(6), 534-540 (1997).
3. I.S. Krull and M.E. Swartz, LC•GC 15(9), 842-845 (1997).
4. M.E. Swartz and I.S. Krull, Analytical Regulatory and Validation Compliance Primer (Marcel Dekker, Inc., New York, 1997).
5. Guidance for Industry: For the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Center for Biologies Evaluation and Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, August 1996).
6. Specifications, Tests and Procedures for Biotechnological/Biological Products (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals in Human Use, Geneva, Switzerland, ICH Q6B, draft 5, September 1997).
7. Validation of Analytical Procedures, Terms and Definitions (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals in Human Use, Geneva, Switzerland, ICH-Q2A, March 1995).
8. Validation of Analytical Procedures: Methodology (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals in Human Use, Geneva, Switzerland, ICH-Q2B, November 1996).
9. G. Hunt, T. Hotaling, and A.B. Chen, J. Chromatogr. A, in press (1998).
10. K.D. Altria, in Capillary Electrophoresis, K.D. Altria, Ed. (Humana Press, Totawa, New Jersey, 1997), pp. 83-97.
11. M.E. Swartz, J.R. Mazzeo, E.R. Grover, and P.R Brown, J. Chromatogr. A 735, 303-310 (1996).