References

1. OECD, Organisation for Economic Co-operation and Development. Principles of Good Laboratory Practice (as revised in 1997). Available at http://www.oecd.org.

2. FDA. 21 CFR Part 58 Good Laboratory Practice Regulations: Final Rule; Department of Health and Human Services: Federal Register: Washington, DC, Sept 4, 1987.

3. ICH International Conference on Harmonization/European Federation of Pharmaceutical Industries Associations. ICH E6 "Good Clinical Practice: Consolidated Guideline." ICH secretariat c/o IFPMA, Geneva, Switzerland, 1996.

4. FDA. 21 CFR Parts 50, 54, 56 and 312: New Drug Product Regulations, Final Rule; Department of Health and Human Services: Federal Register: Washington, DC, March 19, 1987.

5. CAP, College of American Pathologists. Laboratory Accreditation Program, Laboratory Checklists. Northfield, IL, 2000. Available at http://www.cap.org/htm/ ftpdirectory/checklistftp.html.

6. ISO (International Organization for Standardization)/IEC (International Electro-technical Commission). 17025:1999(E). General Requirement for the Competence of Testing and Calibration Laboratories; ISO: Geneva, Switzerland, 1999.

7. FDA. Bioresearch Monitoring Program (BIMO), Compliance Program 7348.810, Sponsors, Contract Research Organizations and Monitors. Department of Health and Human Services: Washington, DC, Feb 21, 2001.

8. FDA. Guide to Inspection of Computerized Systems in Drug Processing. US Government Printing Office: Washington, DC, 1983-381-166.2001, Feb 1983.

9. FDA. Technical Reference on Software Development Activities; Reference Materials and Training Aids for Investigators. US Government Printing Office: Washington, DC, July 1987.

10. FDA. 21 CFR Part 11: Electronic Records: Electronic Signatures: Final Rule; Department of Health and Human Services: Federal Register: Washington DC, March 20, 1997.

11. FDA. Guidance for Industry: Computerized Systems Used in Clinical Trials; US Department of Health and Human Services: Washington, DC, April 1999.

12. FDA. Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11: Electronic Records: Electronic Signatures (CPG 7153.17); US Department of Health and Human Services: Washington, DC, May 1999.

13. FDA. FDA/ORA Regulatory Procedures Manual, Chapter 4: Advisory Actions, Subchapter: Warning Letters; US Department of Health and Human Services: Washington, DC, Aug 1997.

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