21-Sep-2011 - Pfizer says investment in Irish manufacturing facility will boost vaccine conjugation and pegylation capacity and establish a new QC testing hub.
21-Sep-2011 - SAFC is putting special focus on supply chain and quality management as part of its new strategic plan.
21-Sep-2011 - Rx-360 has begun its audit sharing programme to increase knowledge about suppliers and the quality of pharmaceutical raw materials.
20-Sep-2011 - The FDA is targeting companies that reformulate drugs to evade enforcement as it tries to crackdown on the 1000s of products marketed without approval.
20-Sep-2011 - Researchers have called for closer monitoring of pharma manufacturing discharges after detecting endocrine disruption in fish downstream from a Sanofi plant.
19-Sep-2011 - Use of deoxycholate to chemically disrupt influenza viruses during vaccine manufacture could be linked to adverse reactions in children, a journal reports.
15-Sep-2011 - The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.
14-Sep-2011 - The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.
08-Sep-2011 - Difficulties transferring know-how from US Pharmas to plants in Puerto Rico may be responsible for the high incidence of manufacturing quality problems on the island, according to the authors of a new study.
01-Sep-2011 - in-Pharmatechnologist.com presents a round-up of the latest regulatory developments, including a guide for GMP newbies from Health Canada, an internationally-flavoured revision of the EMA’s rules on batch certification and the EDQM’s latest thoughts membrane-based on WFI production.
30-Aug-2011 - The FDA has toned down its support of QbD in final guidance on cutting residual drug in transdermal delivery systems following industry criticism.
30-Aug-2011 - The rise of tablet splitting has prompted the FDA to advise manufacturers on what data is needed to support applications for scored doses.
24-Aug-2011 - Drug counterfeiters are using the Caribbean as a transport hub to ship fake pharmaceutical around the world according to the Antigua Pharmaceutical Society.
23-Aug-2011 - The USP is strengthening ties to the Brazilian pharmaceutical sector to improve quality and drive harmonisation of standards.
22-Aug-2011 - AstraZeneca has adopted and scaled-up silica-based cartridges for removal of metal impurities at its pilot plant.
18-Aug-2011 - The generic drug industry and the US FDA have reached an agreement that would see the former fund the latter’s overseas facility inspection programme to the tune of $299m a year, according to a number of reports.
18-Aug-2011 - The FDA is prioritising development of technologies to compare biosimilars to innovator products in its plan to modernise regulatory science.
10-Aug-2011 - Pfizer is “aggressively” moving toward real-time release (RTR) and believes return on investment can be realised in a year.
09-Aug-2011 - FDA scrutiny of the Burlington, MA sterile plant AMRI bought in 2010 has made the takeover a “money pit”, an analyst said.
08-Aug-2011 - Generic manufacturers can benefit from QbD but fears it will hinder companies in the race to be first-to-file are slowing progress, a VP at Teva said.
08-Aug-2011 - The EC has updated stability testing guidance to cover procedures for variations, such as change in batch size, to marketing authorisations.
04-Aug-2011 - The final results of the US FDA, EMA, TGA joint manufacturing facility inspection programme will make for interesting reading for API producers as they strongly hint the approach is here to stay.
04-Aug-2011 - HP has launched a global authentication service it says will help identify counterfeit and stolen pharmaceuticals.
02-Aug-2011 - Protein engineering is an untapped method for limiting post-production aggregation that causes immunogenicity, academics say.
02-Aug-2011 - The pharma biobanking and compound management services sector welcomed its newest member last week with Brooks Automation’s acquisition of Nexus Biosystems.