good manufacturing practice (GMP)
Successful FDA inspection at Hovione’s API manufacturing plant in Cork, Ireland
The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued. more »
Aug 28, 2014 11:35 AM
GMP Certification Boost for Cobra Biologics
Biologics and pharmaceuticals CMO Cobra Biologics has announced that its GMP Compliance Certification has been extended to include quality control (QC) testing and release of customers’ registered products for in-market supply. more »
Feb 11, 2014 4:50 PM Technology
Dechra Pharmaceuticals Expands LCO Division
The manufacturing business of Dechra Pharmaceuticals, Dechra Pharmaceuticals Manufacturing (DPM), has initiated a significant investment programme to realise a major expansion of its Liquids, Creams and Ointments (LCO) department, with the aim of... more »
Nov 8, 2013 2:00 PM Technology
Supply Chain Programme Now Offers Non-cGMP Ingredients Traceability
Avantor Performance Materials has enhanced its Management of Change (MOC) supply chain alert programme with a new classification to meet the needs of customers wanting full traceability on ingredients not produced under cGMP standards. more »
Sep 18, 2013 11:10 AM Technology
Excipients Certification Ensures Quality of Supply Chain
The EXCiPACT Association — an initiative of the IPEC Federation — will be exhibiting for the first time at CPhI. EXCiPACT is a new, voluntary international certification scheme providing independent third party certification of worldwide... more »
Sep 17, 2013 10:44 AM News
Hand Contact-Free Mopping System Reduces Risk of Cross Contamination
Available exclusively in the UK from Cleanroomshop.com, the new PurQuip ERGO precision cleanroom mopping range is designed to lessen user cross contamination with its hand contact-free system. more »
Jun 10, 2013 3:17 PM Technology
Successful FDA Inspection for UK Contract Laboratory Company
Wickham Laboratories — a specialist GMP contract analytical services provider, based in Hampshire, UK — has reported a successful conclusion to its recent FDA inspection at its Hoeford Point facility in Gosport. more »
Apr 29, 2013 4:19 PM Technology
Single-Use Bioreactor Enhances Cell Culture Performance in Biotechnology Applications
Pall has introduced the XRS 20 Bioreactor system, a bioreactor with agitation properties that incorporates a single-use, easy-to-use Allegro 3D biocontainer. This next generation ‘rocker’ bioreactor, designed for cultivation of mammalian cells in... more »
Apr 3, 2013 4:33 PM Technology
CDMO’s Center for Visual Inspection and Logistics Completes FDA Inspection
Vetter’s new Center for Visual Inspection and Logistics passed its first GMP inspection by the FDA. The inspection was conducted on 11–14 March 2013 to ensure the facility is in compliance with good manufacturing practices. more »
Apr 2, 2013 10:14 AM Technology
GMP Facilities in Germany Ensure Secure and Specialist Supply Chain Solutions
Azelis is one of the leading distributors in the pharmaceutical, personal care, food and animal feed industries that increasingly need to accommodate the latest standards in product handling in terms of purity, storage and filling. As a result... more »
Feb 26, 2013 1:41 PM Technology
Asia's changing regulatory environment and pharma outsourcing
Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention... more »
Jan 14, 2013 2:45 PM Regulatory Affairs Blog
Extractables, leachables and QbD
Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated... more »
Nov 20, 2012 5:29 PM Regulatory Affairs Blog