Extractables and Leachables: Best Practices to Ensure Patient Safety - Pharmaceutical Technology

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Extractables and Leachables: Best Practices to Ensure Patient Safety
The author presents best practices for extractables and leachables.

Pharmaceutical Technology
Volume 37, Issue 7, pp. 20-23

1. K. Boven, S. Stryker, et al., Kidney International, 67, pp 2346-2353 (2005).

2. N. Casadevall, J. Natal, B Viron, et al., New England Journal of Medicine 346, pp. 469-475 (2002).

3. I. Markovic, "Regulatory Perspective on Safety Qualification of Extractables and Leachables," presented at FDA PQRI PODP Workshop, February 2011.

4. A. Sawant "Preliminary Results of a PDA Task Force Examining the Cause, Prevention and Management of TBA and TCA Taints" presented at 2011 PDA/FDA Pharmaceutical Supply Chain Conference, June 2011.

5. Federal Food, Drug and Cosmetic Act.

6. 21 CFR 211, Subpart D.

7. ICH, Q3B(R2), Impurities in New Drug Products, Section 1.3 (ICH, June 2, 2006).

8. D. Norwood, D. Ball, J. Blanchard, et al. "Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products," PQRI submission to US FDA, September 2006.

9. D. Norwood, D. Paskiet, M. Ruberto, et al., Pharmaceutical Research, 25, pp. 727-739 (2008).


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