Keyword: Good Manufacturing Practice (GMP)

News

Boehringer Ingelheim Ohio Subsidiary Enters Consent Decree

01.02.2013 - Ben Venue Laboratories, a unit of German drug company Boehringer Ingelheim, may not freely make or distribute drugs from its facility in Bedford, Ohio, until U.S. regulators have...

Plant Construction & Process Technology

Scrum in the Regulated Environment

25.09.2012 - Sprint to the Finish - Agile methods such as Scrum are beginning to dominate in software development over the classical "waterfall" approaches, to which computer validation has...

Plant Construction & Process Technology

Product Protection by Implementation of Improved Hygiene Zones

25.09.2012 - GMP in View - Within two years, Chemgineering - as general planner and contractor - converted a bottling plant at DSM to comply with current standards. The efficient collaboration...

News

FDA Reform Act Signed into Law

20.07.2012 - In a major victory for the American people, President Obama recently signed into law the U.S. Food and Drug Administration's Safety and Innovation Act that will allow the U.S...

Sites & Services

IT Validation – the Direct Way to Compliance

20.07.2012 - There is rarely a topic which polarizes experts more than the validation of IT-systems. Some would even comprehensively validate systems which only have a remote influence on...

Plant Construction & Process Technology

Recombinant Human Albumin

14.06.2012 - Modern Excipients - Traditionally, excipients have never received the same attention as that given to the Active Pharmaceutical ingredient (API). Instead they have been seen as...

Plant Construction & Process Technology

For Increased Patient Safety

18.04.2012 - Drug Safety - To fight the alarming increase of falsified medicinal products detected, the European Parliament and the Council of the European Union released the Directive 2011/62...

Chemistry & Life Sciences

7 Steps to GMP Compliance

07.03.2012 - Updating Chinese GMP Guidelines - The Chinese know that implementing good manufacturing practice (GMP) is a prerequisite for a certificate but in the past, the Chinese GMP system...