The Challenge of Change - Managing Excipients Control
Colorcon
09-Dec-2010 - The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
08-Dec-2010 - The McCrone Group says pharmaceutical industry need for “quick and dirty” QA/QC solutions in the laboratory and on the factory floor is driving growth of the market for bench-top microscopy.
07-Dec-2010 - Drafting ICH M7 guidance on genotoxic impurities will require a lot of work from industry and regulators but has the potential to resolve a number of issues.
07-Dec-2010 - Lanxess has opened an ion exchange resin production facility in India to cater for growing pharmaceutical manufacturing sector demand for ultrapure water.
06-Dec-2010 - US Contract research laboratory Metrics reveals that benzophenone, a component used in varnish on labels, is able to migrate through HDPE bottles to reach the pills inside.
02-Dec-2010 - bioMérieux will discontinue manufacturing media products for clinical applications and transfer production of other products made at its Portland, US, site elsewhere as part of a restructuring program.
02-Dec-2010 - Counterfeit ACT could support the spread of drug resistant malaria strains from South-East Asia, where chloroquine first became ineffective, to sub-Saharan Africa.
01-Dec-2010 - Updating monographs, changing elemental impurity tests and globalisation were discussed by the USP at its workshop and in interviews with in-PharmaTechnologist.
30-Nov-2010 - Performing environmental testing early in a molecule’s development and including data in tech transfers to CMOs helps ensure there is little mass loading from pilot and commercial plants.
29-Nov-2010 - Narrowly defined pharma self-interest and lack of coordinated political effort means, despite the best effort of some, the problem of counterfeiting may be worsening.
25-Nov-2010 - Aluminium lakes and in-liner packaging can, in some cases, be used to control reactive components in excipients and therefore overcome drug product instability.
24-Nov-2010 - Production of BioDelivery Sciences International’s (BDSI) chronic pain treating drug, ONSOLIS, has resumed after a temporary voluntary shut down at contract manufacturers, Aveva Drug Delivery Systems.
24-Nov-2010 - The knowledge and means are in place to implement real-time release (RTR), a PAT pioneer said at AAPS, but questions remain about whether pharma has the will and desire.
23-Nov-2010 - Johnson & Johnson’s McNeil unit has initiated another recall, this time involving 4m packs of Children’s Benadryl allergy tablets and around 800,000 bottles of junior-strength Motrin caplets.
18-Nov-2010 - German pharmaceutical giant Merck's life science division, EMD Millipore, has launched its 'single-use' Mobius 3L CellReady Bioreactor, for use in the development and optimisation of cell culture processes.
18-Nov-2010 - Agilent Technologies has launched its 708-DS Dissolution Apparatus, a quality control instrument that can be set up for manual or automated applications to measure the release rate of an API over time.
17-Nov-2010 - Combatting counterfeit drugs through forging stronger partnerships is beyond profit, it is about saving lives, AstraZeneca principal scientist Dr Michael Claybourn told a workshop on global drug quality at the AAPS annual meeting in New Orleans.
16-Nov-2010 - The USP is building a database of counterfeit essential medicines to support international drug procurement organisations, such as WHO, and the timely sharing of information between national regulators.
15-Nov-2010 - The European Medicines Agency (EMA) says 12-month API plant joint inspection programme has fostered greater collaboration between international drug industry regulators and cut the number of duplicate visits.
10-Nov-2010 - In the 20 month period before the heparin crisis no Chinese producers were inspected by the FDA and efforts during and since have been hindered by legal and practical challenges.
09-Nov-2010 - The US FDA’s Puerto Rico office may be “having difficulty” monitoring drug manufacturing in the country according to the Congressional Committee on Oversight and Government Reform.
09-Nov-2010 - Substandard and counterfeit antimalarials have been found in Ghanaian hospitals by the Medicines Quality Monitoring programme, a collaborative initiative involving the USP.
04-Nov-2010 - Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.
04-Nov-2010 - ATMI has acquired Artelis, a Belgian biotech firm, in an effort to “get closer to customers” by widening its disposable technology portfolio to the life sciences research and manufacturing sector.
03-Nov-2010 - in-PharmaTechnologist presents interactive charts visualising FDA overseas inspections by type and year, as well as the proportion of sites that may never have been inspected.