Modernization of the Standards for Elemental Impurities - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Modernization of the Standards for Elemental Impurities
Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents.


Pharmaceutical Technology
Volume 37, Issue 2

Summary

Modernization of the heavy-metals standard has been a long time in development and involves experts from all over the world. The improvements include being able to identify the contaminant and being able to measure it at levels where toxic impacts occur. The new term for this standard has changed from "Heavy Metals" to "Elemental Impurities" to reflect these improvements.

Harmonization efforts are proceeding through normal channels at ICH and the parties are agreed to standardize limit criteria whenever the same metals are involved. The normal process of harmonizing existing regional standards is being used.

Jon E. Clark is the Associate Director for Program Policy in the FDA Office of Pharmaceutical Science. He is a founding member of the ICH Expert Working Group on Elemental Impurities (Q3D) and has been a member of multiple ICH working groups,
. John S. Punzi, PhD, is Director, Quality Assurance & Technical Affairs at CHPA.

References

1. D. Abernathey et al., Pharm. Research, 27 (5) 750-755 (May 2010).

2. K. Blake, Pharmacopeial Forum 21 (6) 1632-1637 (Nov.-Dec. 1995).

3. USP, USP-NF 1S to USP 28 (2005).

4. Wang et al., Pharmacopeial Forum 29 (4) 1328-1336 (July-August 2003).

5. N. Lewen et al., J. Pharm and Biomed Analysis 35 739-752 (2004).

6. EMA, Guideline On The Specification Limits For Residues Of Metal Catalysts Or Metal Reagents (London, Feb. 21 2008), http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003586.pdf, accessed Jan. 16, 2013.

7. USP, Pharmacopeial Forum 36 (1).

8. ICH, Quality Guidelines, http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html, accessed Jan. 16, 2013.

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

10. FDA, Drug Shortages, http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm, accessed Jan. 9, 2013.

11. IPEC, ICH Q3D Information Exchange Request, http://ipecamericas.org/content/ich-q3d-information-exchange-request, accessed Jan. 9, 2013.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here