12-Apr-2011 - Microbiology media maker Cherwell Laboratories has announced plans to expand its manufacturing capacity in response to growing industry demand for environmental monitoring products.
11-Apr-2011 - PTI Inspection Systems and Nikka Densok USA have teamed up to take high-voltage leak detection (HVLD) from the factory floor to the pharmaceutical lab.
11-Apr-2011 - Lonza is selling MycoTOOL detection kits for final release testing after inking a distribution agreement with Roche.
07-Apr-2011 - Embedding QbD elements into drug development could make approval timelines and inspection success more predictable, say a Genentech team.
06-Apr-2011 - The FDA has released draft guidance on using separate facilities to prevent cross-contamination with non-penicillin beta lactam antibiotics.
06-Apr-2011 - Sepha, the Belfast, Northern Ireland-based packaging machinery expert, has developed what it claims is the world’s first tool-less vision-based leak detection machine for blister-packs.
05-Apr-2011 - Regulatory demands for ‘in process’ performance data have changed the pharma sector’s approach to materials analysis and enhanced the quality of the drugs it produces according to Freeman Technology.
04-Apr-2011 - ATMI LifeSciences has introduced a new method of integrity testing for its range of single-use bioprocess vessels that, it claims, will take QA in the biomanufacturing sector to a new level.
29-Mar-2011 - The pharmaceutical industry’s PAT initiative is set to drive demand for process analytical instruments, according to a F&S study.
23-Mar-2011 - in-PharmaTechnologist presents a round up of current good manufacturing practice (cGMP) related warning letters sent by the FDA in the first quarter.
16-Mar-2011 - GlaxoSmithKline (GSK) has partnered with Nigeria's National Agency for Food and Drug Administration Control (NAFDAC) to provide a patient SMS verification service for its antibiotic, Ampiclox. .
09-Mar-2011 - US healthcare giant Johnson & Johnson (J&J) has recalled 384,000 of its insulin cartridges on concerns the products could cause serious health problems for diabetics.
07-Mar-2011 - Efforts to detect fakes with handheld spectrometers appear to be having a positive impact on drug quality in Nigeria according to research by US think-tank the American Enterprise Institute (AEI).
28-Feb-2011 - The EU has revised legislation on use of computerised systems in pharma manufacturing to bring it up-to-date.
24-Feb-2011 - Sanofi-aventis has received an FDA warning letter after the agency identified violations of cGMP at its Frankfurt am Main, Germany plant.
21-Feb-2011 - The US HHS has published a national vaccine plan that stresses the need for rapid and flexible manufacturing methods.
17-Feb-2011 - The European Parliament has approved the falsified medicines directive and described it as a “huge step” in efforts to protect patients.
14-Feb-2011 - Variation between drug batches in developing countries poses “serious clinical implications” and should be tackled by regulators.
10-Feb-2011 - Minnesota “has raised its game” in pharma manufacturing and this revival, coupled to drug-device convergence, may justify continuing investment.
09-Feb-2011 - The United States Pharmacopeoia (USP) will help regulators in sub-Saharan Africa ensure drug quality in a new scheme designed to boost testing and analysis capacity.
09-Feb-2011 - A bill requiring biopharm manufacturers to give the FDA early notification of potential drug shortages has been introduced to the US Senate.
07-Feb-2011 - Israeli drugmaker Teva Pharmaceutical Industries has received a US FDA warning letter criticising laboratory operations at its manufacturing facility in Jerusalem.
07-Feb-2011 - US Heparin maker Scientific Protein Laboratories (SPL) says it has resolved “many of the issues” addressed in the US Food and Drug Administration (FDA) warning letter it received late last month.
03-Feb-2011 - Sigma-Aldrich has acquired analytical standards and certified reference materials manufacturer Resource Technology Corporation (RTC) to expand its analytical
03-Feb-2011 - Californian bioproduction expansions could create jobs in 2011 but changes to education are needed to sustain growth, according to a survey.