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Cherwell Labs expands UK media plant

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.

PTI and Nikka Densok team on lab-scale HVLD

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.

Lonza & Roche ink bacteria detection kit deal

11-Apr-2011 - Lonza is selling MycoTOOL detection kits for final release testing after inking a distribution agreement with Roche.

QbD can help approval time & inspections; Genentech

07-Apr-2011 - Embedding QbD elements into drug development could make approval timelines and inspection success more predictable, say a Genentech team.

FDA issues guidance on cross-contamination prevention

06-Apr-2011 - The FDA has released draft guidance on using separate facilities to prevent cross-contamination with non-penicillin beta lactam antibiotics.

Sepha unveils Visionscan device for tool-less blister pack leak detection

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.

PAT and QbD changing powder flow analysis says Freeman

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.

ATMI unveils helium integrity testing for bioprocess vessels at Interphex 2011

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.

Pharma driving short-term demand in PAT

29-Mar-2011 - The pharmaceutical industry’s PAT initiative is set to drive demand for process analytical instruments, according to a F&S study.

Q1 FDA cGMP warning letters

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.

GSK introduces SMS service to combat Nigerian counterfeits

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. .

New J&J recall insulin pump cartridges

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.

Handheld spectrometers improving drug Quality in Nigeria, says AEI

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).

EU revises law on computerised systems in manufacturing

28-Feb-2011 - The EU has revised legislation on use of computerised systems in pharma manufacturing to bring it up-to-date.

German Sanofi plant receives FDA cGMP warning letter

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.

HHS national vaccine plan calls for quick, flexible production

21-Feb-2011 - The US HHS has published a national vaccine plan that stresses the need for rapid and flexible manufacturing methods.

European Parliament votes yes on falsified medicines directive

17-Feb-2011 - The European Parliament has approved the falsified medicines directive and described it as a “huge step” in efforts to protect patients.

Batch variation has implications for developing world

14-Feb-2011 - Variation between drug batches in developing countries poses “serious clinical implications” and should be tackled by regulators.

Minnesota “has raised its game” in pharma manufacturing

10-Feb-2011 - Minnesota “has raised its game” in pharma manufacturing and this revival, coupled to drug-device convergence, may justify continuing investment.

USP launches drug quality programme in sub-Saharan Africa

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.

Bill to tackle prescription drug shortages enters US Senate

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.

News in brief

Teva gets FDA warning for Jerusalem plant

07-Feb-2011 - Israeli drugmaker Teva Pharmaceutical Industries has received a US FDA warning letter criticising laboratory operations at its manufacturing facility in Jerusalem.

SPL responds to US FDA warning letter

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.

Sigma buys pharma standards firm RTC

03-Feb-2011 - Sigma-Aldrich has acquired analytical standards and certified reference materials manufacturer Resource Technology Corporation (RTC) to expand its analytical

Cali bioproduction set to grow but education must improve

03-Feb-2011 - Californian bioproduction expansions could create jobs in 2011 but changes to education are needed to sustain growth, according to a survey.

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