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,

Merck To Relocate Its Headquarters

Posted by Jim Menoutis on Wed, Oct 10, 2012 @ 01:18 PM

Since 1992, Merck has called  Whitehouse Station, NJ home to its corporate headquarters. Now followings its merger with Schering Plough in 2009, it has decided to close and shutter the facility, relocating its headquarters and some  2,00 employees and contractors to new digs scattered around New Jersey. And the company is billing the move as a sign of its increasing corporate.

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Topics: Roche, USP, Generic Version, Merck, Merck R&D, Merck Whitehouse Station, Generics, Life science research, Merck to Move, Sanofi

Elemental Impurities- An Interview with the USP

Posted by Jim Menoutis on Mon, Sep 10, 2012 @ 12:52 PM

Are you are concerned about the level of arsenic, cadmium, lead or mercury that may slip through manufacturing processes and find their way into pharmaceuticals? Well, the US Pharmacopeia is working to ease any worries. The non-profit, which sets standards for the identity, strength, quality, and purity of medicines, is working on two new ‘chapters’ that would help drugmakers upgrade their testing for so-called heavy metals. The new guidance becomes official on December 1, although implementation will not be required until May 1, 2014. Why? We spoke with Kahkashan Zaidi, a senior scientific liaison at USP, about these new chapters and the implications…

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Topics: USP, Elemental Impurities