An Industry Perspective on Harmonization and Implementation of ICH and USP Requirements - Pharmaceutical Technology

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An Industry Perspective on Harmonization and Implementation of ICH and USP Requirements
The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012, and are to be implemented by the industry by May 2014.

Pharmaceutical Technology
Volume 36, Issue 11, pp. 58-64, 70-72


1. A. Cross, Pharm. Technol. 36 (8), 62–64 (2012).

2. USP 35–NF 30 General Chapter <232>, "Elemental Impurities—Limits."

3. USP 35–NF 30 General Chapter <232>, "Elemental Impurities—Procedures."

4. USP 28–NF 23 General Chapter <231>, "Heavy Metals."

5. ICH, Q3D, Metal Impurities, Step 1 Concept Paper (2009).

6. A. DeStefano, "USP's Elemental Impurities Initiative —Current Status," presentation at the 2010–2015 Prescription/Non-Prescription Stakeholder Forum—Meeting #1 (Nov. 2009).

7. K.B. Blake, "Harmonization of the USP, EP, and JP Heavy Metals Testing Procedures," USP Pharmacopeial Forum 21 (6) 1632 (1995).

8. Basel Working Group on Determination of Metal Traces, Basel Excipients Working Group, "Determination of Metal Traces—A Critical Review of the Pharmacopeial Heavy Metals Test," USP Pharmacopeial Forum, 21 (6) (Nov.–Dec. 1995).

9. A. Lodi, "The Evolution of the Pharmacopoeial Test for Heavy Metals," Pharmeuropa Scientific Notes, 2007–1, p. 33.

10. E. Silverman, "Heavy Metals In Your Drugs? USP's Zaidi Explains," Pharmalot Blog, July 24, 2012,

11. USP, "New Quality Standards Limiting Elemental Impurities in Medicines Announced," USP Press Release, May 23, 2012.

12. USP Commentary—Second supplement to USP 35–NF 30,

13. J.F. Kauffman, Reg. Toxicol. and Pharmacol. 48 (2) 28–134 (2007).

14. USP General Notices, "Test and Assays, Foreign Substances and Impurities," USP 31, p. 7 (2008). (Note: This exact text was removed when the General Notices were restructured in USP 32. This is still a valid view of the role of a pharmacopoeia.)

15. ICH, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Nov. 2000).

16. FDA, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics (Rockville, MD, 1999).


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