From The Corner Lab - Blog Posts

New Guidance Available for Elemental Impurities: Meeting Compliance with USP, ICH Q3D, FDA and GMP Requirements.

Posted by Jim Menoutis on Tue, Oct 27, 2015 @ 02:01 PM

A new guide is available covering meeting compliance with USP<232> & <233>, ICH Q3D, FDA’s and GMP requirements. The guide details time lines for compliance, including FDA and EQDM/EMA deadlines for both existing and new drug products. In addition to covering USP’s requirements , it also provides an in depth analysis of FDA’s requirements for complying with ICH Q3D. The guide also covers what will be needed to demonstrate compliance with elemental impurities during FDA GMP inspections.  Click Here to Download


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Topics: USP, cGMP, USP <232>, FDA, ICH, Q3D, FDA ANDA,

Elemental Impurities: Where we were then, Where we are now, and Where are we going

Posted by Jim Menoutis on Tue, Sep 22, 2015 @ 05:44 PM

On Wednesday, September 9, 2015 the FDA published the final Q3D Elemental Impurities Guidance for Industry. At the same time, Contract Pharma Magazine published a feature article in its September issue on elemental impurities. The feature discusses elemental impurities in depth with perspectives on USP and regulatory the expectations from both FDA and EMA. The article notes that” …In both Europe and the US, the EQDM/EMA and FDA deadlines for compliance of new marketing authorization and new drug applications, respectively, with ICH Q3D are each set for June 2016…” to access the article in full click below:

Click here to access the article

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Topics: USP <232> USP <2332>, Elemental Impurities, USP <233> elemental Impurities, FDA, ICH

Quantex Issues New Guide on Elemental Impurities

Posted by Jim Menoutis on Tue, May 06, 2014 @ 04:13 PM

Quantex Laboratories has just release a new whitepaper/guide on Elemental Impurities, titled "Elemental Impurities -Preparing For The New regulations and Guidelines". It provides a current overiew of Elemental Impurites and what to expect with  the Deceber 2015 implementation date.

The whitepaper/guide provides a review of Current USP requirements for General Chapters <232>, <233> and <2322>. It also details and compares the new European Pharmacopiea  5.20 "Metal Catalysts or Metal Reagents", and 2.4.40 "Determination of Metal Catalysts or Metal Reagent Residues". The paper also covers the the ICH Q3D guidelines.

 

 

 To download your free copy click here

 

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Topics: USP <232> USP <2332>, Elemental Contaminants in Dietary Supplements, Elemental Impurities, USP <232>, USP <233> elemental Impurities, ICH, Q3D

USP Announces Revised Timeline, Effective Date for Elemental Impurities Limits and Procedures

Posted by Jim Menoutis on Fri, Jan 17, 2014 @ 12:32 PM

In September 2013, the Elemental Impurities Expert Panel reviewed the Step 2 limits of the International Conference on Harmonization (ICH) Q3D Elemental Impurities Working Group, which were released in June 2013 and recommended revisions to General Chapter <232> Elemental Impurities—Limits to partially align with the ICH Q3D limits. In October 2013, the General Chapters—Chemical Analysis Expert Committee endorsed the Expert Panel's recommendations.

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Topics: USP <232> USP <2332>, Elemental Contaminants in Dietary Supplements, Elemental Impurities, USP <233> elemental Impurities, ICH, Q3D

ICH Issues Q3D step 2b Elemental Impurities Guideline; USP & EMA Take Action

Posted by Jim Menoutis on Wed, Aug 28, 2013 @ 05:17 PM

The International Conference on Harmonization (ICH) has started the consultation period on elemental impurities. ICH Q3D - Impurities: Guideline for Elemental Impurities - laying out limits for metallic impurities in pharmaceutical ingredients and preparations and detailing the testing procedures used to detect and measure them.  With the July 26, 2013 issuance of the guideline, Q3D has now entered step 2b of a five-step implementation process. There is a six-month comment period which gives  the industry and other stakeholders time to forward their comments.

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Topics: Elemental Impurities, CHMP, USP <232>, USP <233> elemental Impurities, FDA, ICH, Q3D, EMA