The Challenge of Change - Managing Excipients Control
Colorcon
12-Oct-2011 - The US EPA plans to fine API manufacturer Rhode Technologies for alleged hazardous waste failings at its plant.
12-Oct-2011 - The FDA has published final guidance on the use of excipients as anti-counterfeiting tools in solid oral dosage forms.
11-Oct-2011 - The United States Pharmacopeial Convention (USP) has forged closer ties with Russian regulators to help tackle substandard pharmaceuticals and harmonize quality standards.
11-Oct-2011 - The Irish Medicines Board (IMB) has published guidance for cold-chain storage and transport of APIs and finished products.
10-Oct-2011 - ProteinSimple has introduced a protein therapeutic quality control monitoring system to cut sample analysis times.
04-Oct-2011 - The EMA is developing new vaccine quality guidelines in response to shortcomings seen during the influenza pandemic.
04-Oct-2011 - The US FDA may add product and violation-specific searches to its publicly available database of inspections as part of a transparency push.
03-Oct-2011 - The Australian TGA is considering adopting EMA guidance on residual solvents, genotoxic impurities and other GMP topics.
29-Sep-2011 - The US FDA has filed a permanent injunction against a US drugmaker and sent a warning letter to a Chinese API producer following cGMP problems.
26-Sep-2011 - Ukraine's parliament, the Verkhovna Rada, has voted unanimously in favour of new legislation which will criminalise the production and trafficking of counterfeit drugs.
26-Sep-2011 - ProMetic Life Sciences is supplying an affinity adsorbent to a Chinese biopharm for use in scale-up of a biosimilar.
26-Sep-2011 - Process Systems Enterprise (PSE) has developed crystallisation modelling software to improve throughput and simplify scale-up.
22-Sep-2011 - PerkinElmer has launched its new Universal Operational Qualification (UOQ) service for pharmaceutical labs.
22-Sep-2011 - The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.
21-Sep-2011 - Pfizer says investment in Irish manufacturing facility will boost vaccine conjugation and pegylation capacity and establish a new QC testing hub.
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 - GE Healthcare will expand its range of biomanufacturing technologies under a new oncology-focused investment project.
15-Sep-2011 - Pall continued the trend seen throughout 2011 by posting double-digit sales growth at its biopharm unit in the fourth quarter.
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.
14-Sep-2011 - The USP is to revise over-the-counter (OTC) dosage form monographs as part of its modernisation collaboration with the FDA.
13-Sep-2011 - Sartorius Stedium Biotech (SSB) and GE Healthcare Life Sciences say new cross licensing deal will aid development of their respective biomanufacturing tech offerings.
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.
07-Sep-2011 - CellCura has inked an agreement with IDT Biologika for the testing and adaptation of its protein-free (PF) media for the production of cell lines for vaccine manufacturing.
06-Sep-2011 - Roche has launched a new analysis platform designed to help bio manufacturers monitor and optimise production operations.