The concept of pharmaceutical quality

American Pharmaceutical Review

Volumn 7, Issue 6, 2004, Pages 10-15

  Woodcock, Janet ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 57349152279     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (7)

1. Bruttin, F. and D. Dean, "A Risk-Based Approach to Reducing the Cost of Compliance in Pharmaceutical Manufacturing," Pharmaceutical Technology Europe, vol. 11, no. 5, pp. 36-44, May 1999.
2. Food and Drug Administration, Science Board, Presentations on CGMP Initiative, transcript of the Proceedings, November 16, 2001, http://www.fda.gov/oc/advisory/sciboard111601.html.
3. Food and Drug Administration, Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach, Final Report - Fall 2004, September 27, 2004.
4. Swan, J.P., "The 1941 Sulfathiazole Disaster and the Birth of Good Manufacturing Practices," Science & Technology, vol. 53, no. 3, May-June 1999.
5. Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter A, Section 501(a)(2)(B).
6. Hussain, A.S., "Quality by Design: Next Steps to Realize Opportunities," presentation to the Food and Drugs Administration Advisory Committee for Pharmaceutical Science: Manufacturing Science Subcommittee, September 17, 2003.
7. Knapp, J.Z., " 'Absolute' Sterility and 'Absolute' Freedom from Particle Contamination," PDA Journal of Pharmaceutical Science and Technology, vol. 52, no. 4, July-August 1998.