The Challenge of Change - Managing Excipients Control
Colorcon
23-Nov-2011 - The US FDA has sent Mylan a warning letter after inspectors found GMP testing failings at its Puerto Rico facility.
21-Nov-2011 - Ben Venue Laboratories has voluntarily suspended manufacture at the Ohio plant linked to drug shortages.
21-Nov-2011 - Real-time release testing can save money by cutting recalls but “fear of the unknown” is limiting use, a FDA official said.
16-Nov-2011 - ProMetic grew third quarter sales on demand for affinity absorbents and expects the recovery to continue.
15-Nov-2011 - The USP has forged closer bonds with the Chilean Pharmacopoeia Foundation (CPF) in the latest of a series of agreements with regional drug quality groups.
14-Nov-2011 - Processing technology maker Pall has opened a new centre of excellence in Singapore in a bid to capture a share of the country’s growing biomanufacturing sector.
14-Nov-2011 - The EDQM has suspended five CEPs in a little over a month, bringing the total to nine so far this year.
10-Nov-2011 - The US FDA is publishing immediate and modified release QbD examples to help generics companies prepare for full implementation in 2013.
09-Nov-2011 - The EMA plans to update guidance on certification and batch release in response to globalisation of the pharma supply chain.
08-Nov-2011 - The Chinese FDA should hire more CMC reviewers to encourage QbD applications, a Pfizer executive said.
08-Nov-2011 - The US FDA has sent Genentech a GMP 483 after inspectors found failings in the capping process for Avastin.
07-Nov-2011 - Greater FDA oversight of US manufacturing plants increased the number of drug recalls in Q3 in a trend that is likely to continue according to a new report.
07-Nov-2011 - The EMA is to clarify when a product should be manufactured in a dedicated facility to avoid risk of cross contamination.
07-Nov-2011 - The US FDA has updated its ICH Q8, Q9 and Q10 question and answer document to clarify design space requirements.
27-Oct-2011 - Retrofitting stainless steel plants with single-use systems is driving a “paradigm shift” in drug production but creates logistical problems, an AAPS panel said.
26-Oct-2011 - Multinational biotech giant, Lonza, has completed the acquisition of US-based Arch Chemicals as the company bids to tap into the microbial control sector.
26-Oct-2011 - 3M, the US-headquartered multinational, has launched a new range of bio filters which it says raise the benchmarks for flow-rate, organism reduction and efficiency across a range of applications.
25-Oct-2011 - In the next 25 years pharma will shift from batch to continuous manufacturing and make current production methods “obsolete”, an FDA director said.
20-Oct-2011 - Avantor is to offer tamper-evident seals on all its pharma raw material and excipient containers by the end of the year.
19-Oct-2011 - Hospira says ‘quality actions’ taken to fix problems at key injectable drug manufacturing plant in US reduced its third quarter earnings.
19-Oct-2011 - The FDA has sent GSK a GMP warning letter after finding failings in steps to prevent microbiological contamination at a UK site.
19-Oct-2011 - Canadian pharma manufacturers’ plan to stop drug shortages by sharing information fails to tackle underlying concerns, an analyst said.
17-Oct-2011 - Spam filtering and identification is needed to stop Twitter becoming another platform for pushers of fake or substandard drugs, researchers say.
17-Oct-2011 - BRIC is funding biologics aggregation and protein production predictability research at the University of Manchester.
13-Oct-2011 - The EMA may apply proposed porcine trypsin guidelines to existing products, such as a GSK vaccine, to cut viral contamination.