Quality Issues for Multiregional Clinical-Trial Materials - Pharmaceutical Technology

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Quality Issues for Multiregional Clinical-Trial Materials
The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.


Pharmaceutical Technology
Volume 35, Issue 10, pp. 124-132

References

1. Federal Food, Drug, and Cosmetic Act, 1938.

2. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 210, "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General."

3. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 211, "Current Good Manufacturing Practice for Finished Pharmaceuticals."

4. EudraLex, Rules Governing Medicinal Products in the European Union, Volume 4 (Brussels), "EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use."

5. FDA, Draft Guidance for Industry: CGMP for Phase I Investigational Drugs (Rockville, MD, July 2008).

6. ICH, Q3A (R2) Impurities in New Drug Substances (2006).

7. ICH, Q1A (R2) Stability Testing of New Drug Substances and Products (2003).

8. ICH, Q3B (R2) Impurities in New Drug Products, Step 4 version (2006).

9. EMA, Guideline on the Limits of Genotoxic Impurities (London, June 2006).

10. EMA, Questions & Answers on the CHMP Guideline on the Limits of Genotoxic Impurities (London, Sept. 2010).

11. FDA, Draft Guidance for Industry: Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (Rockville, MD, Dec. 2008)

12. University of California, Berkeley, The Carcinogenic Potency Database (2010).

13. L. Muller et al., Regul. Toxicol. Pharmacol. 44 (3), 198–211 (2006).

14. MultiCASE, Multicase Inc Bioactivity Software, http://www.multicase.com/, assessed May 20, 2010.

15. Network Sciences Corp., DEREK, NetSci: Software for Computer Assisted Molecular (Drug) Design, http://www.netsci.org/, assessed May 20, 2010.

16. PhRMA, Industry Survey on Genotoxic Impurities (Washington, DC, 2008).

17. S. Colgan et al., Regulatory Rapporteur 7 (5), 23–29 (2010).

18. S. Ibric et al., J Pharm Pharmacol. 59 (5) 745–50 (2007).


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