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

ADVERTISEMENT

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


BioPharm International
pp. 34-37

REFERENCES

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).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
New Report Details Players and Pipelines in the Biosimilar Space
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
Author Guidelines
Source: BioPharm International,
Click here