Suggested Reading

Agalloco, J.P., Validation of Pharmaceutical Processes: Sterile Products Revised, 2nd ed., F.J. Carleton, Ed. (Marcel Dekker, 2000).

Code of Federal Regulations, Food and Drugs, "Good Laboratory Practice for Nonclinical Laboratory Studies," Title 21, Part 58 (U.S. Government Printing Office, Washington DC, revised April 2000).

Danan, H., "Applying Good Laboratory Practice Regulations," Pharm. Technol. Eur. 15(6), 39–43 (2003).

DeSain, C. and Sutton, C.V., Documentation Practices: A Complete Guide to Document Development and Management for GMP and ISO 9000 Compliant Industries (Advanstar Communications, Cleveland, OH, 1996).

DeSain, C., Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations (Advanstar Communications, Cleveland, OH, 1993).

Dictionary of Clinical Research, J. Winslade and D.R. Hutchinson, Eds. (Brookwood Medical Publications, Brookwood, UK, 1992).

Edwards, M. and Murji, S., "The Development of GLP Regulations and Their Current Status in Preclinical Safety Studies," Pharm. Technol. Eur. 12(5), 76–82 (2000).

FDA. "Current Good Manufacturing Practice for Finished Pharmaceuticals," Code of Federal Regulations, Food and Drugs, Title 21, Part 211 (U.S. Government Printing Office, Washington DC), revised 1 April 2001.

FDA. "Biological Products," Code of Federal Regulations, Food and Drugs, Title 21, Part 600 (U.S. Government Printing Office, Washington DC), revised 1 April 2001.

FDA. "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs," Title 21, Part 210–211 (U.S. Government Printing Office, Washington DC, revised April 2000).

FDA, "Medical Devices: Current Good Manufacturing Practices (CGMP) Final Rule; Quality System Regulation," Federal Register 61(195), 52601–52662 (U.S. Government Printing Office, Washington DC, October 1996).

FDA, "Good Laboratory Practice Regulations; Final Rule," Title 21, Part 58, Federal Register 52(172), 33768–33781 (4 September 1987).

FDA, "Good Laboratory Practice Regulations; Proposed Rule," Title 21, Part 58, Federal Register 49(210), 43530–43537 (29 October 1984).

FDA, "Nonclinical Laboratory Studies, Final Rule," Federal Register 43(247), 59986–60025 (U.S. Government Printing Office, Washington DC, 22 December 1978).

FDA, "Good Laboratory Practice (GLP), Proposed Rule," Federal Register 41(31), 6878–6894 (U.S. Government Printing Office, Washington DC,13 February 1976).

Good Laboratory and Clinical Practice Techniques for the Quality Assurance Professional, P.A. Carson and N.J. Dent, Eds. (Heinemann Newnes, Oxford, UK, 1990).

Helle, M.-R., Yliruusi, J., and Mannermaa, J.-P., "A Literature Review of Pharmaceutical Process Validation," Pharm. Technol. Eur. 14(3), 52–57 (2003).

Immel, B.K., "A Brief History of the GMPs: The Power of Storytelling," BioPharm 13(8), 26–36, 61 (2000).

Immel, B.K., "GMP Issues: The Forgotten GLPs," BioPharm 12(4), 40–43, (1999).

Methods in Biotechnology, H.-P. Schmauder, Ed. (Taylor and Francis Ltd, London, UK, 1997).

Smith, R.B., The Development of a Medicine (The Macmillan Press, Basingstoke, UK, 1985).

Tambwekar, K.R. and Garg, S., "Proper Management of Laboratory Notebooks: A Step Towards Success," Pharm. Technol. Asia, 36–40 (December 2001). BPI