Page 305 - Chiral Separation Techniques

284 10 The Use of SMB for the Manufacture of Enantiopure Drug Substances: From …

[48] Mazzotti M., Pedeferri M.P., Morbidelli M., Proceedings of Chiral Europe 96, Strasbourg 14–15
October 1996, Published by Spring Innovations Ltd, Stocport, England, 1996.
[49] Mazzotti M., Storti G., Morbidelli M., J. Chromatogr. A., 769 (1997), 3.
[50] Aiche J., 42 (1996), 2734.
[51] Strube et al., J. of Chrom. A, 769, pp. 81–92, 1997.
[52] Nagamatsu S. and Makino S., poster presented during the International Symposium on Chiral Dis-
crimination, Nagoya, 1997.
[53] Ruthren and Chuthren D.M., Chinsc. B., Chem. Eng. Sci., 44 (5), 1011–1038, 1989.
[54] Hotier G. and Nicoud R.M., US Patent 5,578,216.
[55] Hotier G., Cohen C., Couenne N., and Nicoud R.M., US Patent 5,578,216.
[56] Nicoud et al., US patent 5,422,07 1995.
[57] Biressi G., Ludemann-Hombourger O., Nicoud R.M., Morbidelli M., J. Chromatogr. A, submitted
for publication (1999).
[58] Seidel-Morgenstern A. and Nicoud R.M., Isolation and purification, vol. 2, p. 165–200, 1996.
[59] Van Deemter J.J., F.J. Zuiderweg and A. Klinkenberg, Chem. Eng. Sci., 5 (1956) 271.
[60] Knox J.H., J. Chromatogr. Sci., 15 (1977) 352.
[61] Horvath C. and H.J. Lin, J. Chromatogr., 149 (1978) 43.
[62] Endele R., I. Halasz and K. Unger, J. Chromatogr., 99 (1974) 377.
[63] Mazzotti M., Storti G., Morbidelli M., AIChE J., 40 (1994), 1825.
[64] Current Good Manufacturing Practice for Finished Pharmaceuticals, Calculation of Yield, (1998),
CFR, Title 21, Part 211, Volume 4, Section 211.103.
[65] Current Good Manufacturing Practice for Finished Pharmaceuticals, Time Limitations on Produc-
tion, (1998), CFR, Title 21, Part 211, Volume 4, Section 211.111.
[66] Quality System Regulation, Production and Process Controls, (1998), CFR, Title 21, Part 820, Vol-
ume 8, Section 820.75.
[67] Medical Devices: Draft Global Harmonization Task Force Study Group 3 Process Validation Guid-
ance, (1998), Fed. Regist., Docket No. 98D-0508.
[68] Nicoud R.M., Pharmaceutical Technology Europe (1999) 11 [3], 36–44 and 11 [4] 28–34.

FDA Documents

Current Good Manufacturing Practices for Finished Pharmaceuticals, U.S. Food and
Drug Administration, 21 CFR 210 and 211
FDA Guideline for Submitting Documentation for the Stability of Human Drugs
and Biologics, Center for Drugs and Biologics, February 1987
FDA Guideline for Submitting Documentation in Drug Applications for the
Manufacture of Drug Substances, Center for Drugs and Biologics, February 1987
FDA Guide to Inspection of Bulk Pharmaceutical Chemicals, Office of Regional
Operations and Center for Drug Evaluation and Research, September 1991, Refor-
matted May 1994
FDA Biotechnology Inspection Guide, Office of Regional Operations, November
1991
FDA Guideline to Inspection of Validation of Cleaning Processes, Office of Reg-
ulatory Affairs, July 1993
HHS/FDA “International Conference on Harmonisation; Stability Testing of New
Drug Substances and Products; Guideline; Availability; Notice,” Federal Register,
September 22, 1994