The Challenge of Change - Managing Excipients Control
Colorcon
07-Feb-2012 - BAC BV and Life Technologies have launched a new range of affinity columns will ‘unlock’ high speed affinity HPLC for pharmaceutical processing.
07-Feb-2012 - A proposed US act aims to impose limitations on consent decrees and stop the “regulatory frenzy in Washington”.
06-Feb-2012 - The Indian Drug Manufacturers Association (IDMA) plans to amp up pharma business in Tamil Nadu by helping more companies meet WHO production standards.
06-Feb-2012 - The WHO is urging countries to collaborate on tackling substandard drugs and strengthening supply chains at a new annual meeting.
02-Feb-2012 - The US FDA has called for more authority to ensure any track-and-trace system is binding for industry and pre-empts state laws.
31-Jan-2012 - The FDA has hit Novartis with another 483 after finding seven repeat observations and a backlog of 1,360 overdue consumer complaints.
30-Jan-2012 - The FDA has updated its question and answer document to help manufacturers of topical antiseptics prevent contamination.
26-Jan-2012 - in-PharmaTechnologist presents a round-up of issues within the pharmaceutical manufacturing industry, including Novartis’ plans to restart Nebraska ops and problems for Roche at it’s South Carolina facility.
26-Jan-2012 - The US has filed a “groundbreaking” injunction against Ranbaxy to force the generic giant to make “fundamental changes” at its plants.
25-Jan-2012 - Vivalis nearly doubled revenues from its vaccine production platform in 2011 and has inked a third mAb discovery programme with Sanofi.
24-Jan-2012 - The FDA has followed the EMA in approving the Framingham, MA plant that Genzyme hopes will cut production bottlenecks.
24-Jan-2012 - Sartorius Stedim Biotech (SSB) says its partnership with Refine Technology will help meet demand for greater connectivity between retention devices and bioreactors and save Pharmas time and money
23-Jan-2012 - Poor aseptic technique at compounding pharmacies is the most likely cause of Avastin-related vision loss, researchers claim.
19-Jan-2012 - SGS’ new analytical lab in Mumbai, India will open later this week just six months after the analytical services firm began its construction .
19-Jan-2012 - Sartorius Stedum Biotech (SSB) and G-Con Manufacturing claim their biomanufacturing technology partnership will change the ‘fundamentals’ of process design.
19-Jan-2012 - The FDA has published a QbD approach to modified release tablet development to help generic companies meet its 2013 deadline.
17-Jan-2012 - PIC/S has strengthened promotion of global GDP harmonisation and confidentiality in a revision to its documentation.
17-Jan-2012 - The US FDA plans to study foreign regulators’ GMP inspection reports with a view to using them to support its enforcement efforts.
16-Jan-2012 - The US FDA has sent its generic user fee recommendations to Congress ahead of a meeting to discuss the plan next month.
16-Jan-2012 - The Chinese government is encouraging development of new vaccine production processes in a bid to achieve self-reliance.
11-Jan-2012 - Greater collaboration between regulators, suppliers and manufacturers is needed to reverse decades of supply chain neglect, an expert said.
11-Jan-2012 - Hospira will uncover more issues as it gets to the root cause of its quality troubles but the situation is “very fixable”, its CEO said.
10-Jan-2012 - The value of counterfeit pharmaceuticals seized at US borders jumped 200 per cent in 2011 as enforcement actions took effect.
09-Jan-2012 - Novartis expects to take a $120m charge to improve a US manufacturing plant and recall drugs after the FDA sent it a 483.
09-Jan-2012 - The USP has published draft supply chain integrity guidance outlining steps to stop counterfeit or adulterated drugs reaching patients.