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QA/QC

News headlines

US FDA warns compounders of contaminated baclofen API from China

14-Dec-2015 - The US FDA has alerted compounders of potential particulate matter in an API sourced from Chinese drugmaker Taizhou Xinyou Pharmaceutical & Chemical.

Ingredient importers: Get ACE in place by February, says US FDA

10-Dec-2015 - A new system will simplify and speed-up US imports of pharma ingredients the FDA says, but industry needs to be on board by the end of February.

Severe shortage? 1,500 inspectors too few for India's 10,000 plants says ASSOCHAM

09-Dec-2015 - New Delhi industry group ASSOCHAM says international criticism of Indian drug and API plants is due to a ‘severe shortage’ of regulatory inspectors.

Danaher buys track & trace tech firm Laetus; unveils 'Fortive' name ahead of split

07-Dec-2015 - Danaher has bought production line monitoring and coding tech firm Laetus to bolster its life science product ID offering ahead of a planned corporate split next year.

GSK Japan delays alopecia drug launch after Catalent manufacturing halt

03-Dec-2015 - GSK has delayed the Japanese launch of a male pattern baldness drug after a production halt at a French facility operated by its CMO, Catalent.

MHRA gives troubled Wockhardt plant all clear to manufacture for UK

02-Dec-2015 - Wockhardt has received a GMP certificate from the UK’s MHRA for its facility in Chikalthana, India.

FDA warning for Sandoz after data and training issues at Indian plants

25-Nov-2015 - Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.

Xellia buys ex-Ben Venue site and aims to restart production in 2017

25-Nov-2015 - Restarting production at the former Ben Venue facility in Ohio will be a “significant task” says Xellia Pharmaceuticals which plans to invest after buying the site from Hikma.

Seaweed shortage prompts Thermo to suspend sale of two lab agars

25-Nov-2015 - Thermofisher Scientific has stopped selling two agars used in pharmaceutical industry control labs, citing a worldwide shortage of the seaweed used to make them.

Catalent: Suspension at French plant likely due to human interference

17-Nov-2015 - Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.

Q&A

MHRA medical assessors tackle challenging evolving drug complexity

12-Nov-2015 - The UK regulatory agency is recruiting for medical assessors, but with drug-device combinations, biologics and personalised medicines making the job more complex, do you have what it takes?

Women sue Endo for packaging mix-up ‘that left 113 pregnant’

12-Nov-2015 - More than one hundred women are suing a subsidiary of Irish manufacturer Endo International, claiming a packaging error caused their contraception to fail and result in unwanted pregnancies.

Jobs

ABPI: fix the manufacturing skills gap now

11-Nov-2015 - The UK biopharma industry is reporting difficulties finding manufacturing workers with the skills to make vaccines, biologics, and advanced therapy medicinal products (ATMP), according to ABPI.

Government blames India's poor quality stigma on 'turf war' with West

09-Nov-2015 - The over-reaction to quality infringements by Indian drugmakers is part of a “turf war” with Western firms, the Indian Government says.

Lonza: industry should shift to QC automation

04-Nov-2015 - While pharma is increasing use of automation and data integration tools in process development and manufacturing, it lags behind in electronic documentation of quality control, according to Lonza Biologics QC director Jessica Jean.

Indiana aspirin maker hit with Warning due to tablet inconsistencies

04-Nov-2015 - Inconsistent tablet colour and issues with compressing procedures have landed Indiana OTC maker American Family Pharmacy (AFP) with a US FDA warning letter.

Pfizer: No safety snags at China plant despite ‘missing document’ 483

03-Nov-2015 - Pfizer says there were no safety or quality problems with the drugs made at the Chinese site reportedly issued with a 483 for expired materials and missing paperwork.

Explosion-hit GSK plant loses GMP certificate

26-Oct-2015 - A GlaxoSmithKline plant in China that was hit by an explosion in the summer has had its Good Manufacturing Practice (GMP) certificate revoked by the UK medicines regulator.

Compounder refuses to halt production despite FDA alert

20-Oct-2015 - The US FDA has issued an alert warning the public not to take drugs marked as sterile by compounding firm Qualgen.

Pay-as-you-go or unlimited access? EMD ups its risk assessment service

20-Oct-2015 - EMD Millipore will offer drugmakers two-years of unlimited access to its suite of raw materials dossiers for 20,000€ as part of its enhanced portfolio offering.

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