Industry news

NSF Health Sciences experts bring you the latest news updates from the industry

PhEur - Uniformity of Dosage Units Proposal

Monday the 4th April 2011

There is a proposal for a new general chapter in the European Pharmacopoeia – Demonstration of Uniformity of Dosage Units (UDU) using large sample sizes (see attached).

In order to take advantage of increased batch control offered by process analytical technology (PAT) tools, for example large sample sizes used for the control of uniformity of dosage units, a new Ph. Eur. general chapter 2.9.47 is proposed. Comments on the proposed general chapter should be submitted by 30 June 2011.

The document can be found at the following site:

http://www.edqm.eu/en/Homepage-628.html

Peter Gough, Partner, NSF-DBA, UK

    Quick links

    NSF Health Sciences have offices in Kirkbymoorside and Sheffield, UK and Boston and Ann Arbor, USA

    A word from NSF Health Sciences

    The legislation and guidance that apply to the healthcare industries is forever changing. NSF Health Sciences will provide you with regular updates on what is new and will also provide you with expert interpretation of these changes - what they mean

    Peter Gough

    © NSF Health Sciences 2014

    Registered Office: NSF Health Sciences, The Georgian House, 22/24 West End, Kirkbymoorside, York, UK, YO62 6AF
    Registered in England and Wales No: 3432550 | Tel: +44(0)1751 432999 | Fax: +44(0)1751 432450 | Email: pharmamail@nsf.org
    US Office: NSF Health Sciences, 6th floor, 129 South St, Boston, MA 02111 | Tel: 1-857-277-0060 | Fax: 1-857-284-7207 | Email: USpharma@nsf.org