GMP
Fresenius Kabi hit by second FDA warning letter
July 10, 2013Manufacturing and Production API, FDA, Fresenius Kabi, GMP
German generic drugmaker Fresenius Kabi has been sent another warning letter from the FDA citing deficiencies at a manufacturing plant. …
China tightens quality standards for pharma distributors
July 2, 2013Manufacturing and Production China, FDA, GMP, GSP
From 1 July new pharmaceutical distributors in China will be obliged to adhere to the country’s recently-issued Good Supply Practice …
Novartis receives FDA warning
June 6, 2013Manufacturing and Production, Sales and Marketing CGMP, FDA, GMP, Novartis
The FDA has castigated Novartis for what it calls ‘significant violations’ of current good manufacturing practice (CGMP) regulations for finished …
FDA issues draft guidance on contract manufacturing
June 3, 2013Manufacturing and Production FDA, GMP, Taylor
The US Food and Drug Administration FDA has published draft guidance on quality agreements between pharma companies and contract manufacturers. …
Canada tightens GMP rules for active ingredients
May 21, 2013Manufacturing and Production API, Canada, GMP
Canada’s Food and Drug Regulations have been amended to extend the requirements for Good Manufacturing Practices (GMP) to active pharmaceutical …
Excipient certification scheme launches in US
May 17, 2013Manufacturing and Production EXCiPACT, GMP
A certification scheme for pharmaceutical excipients to make it easier for drugmakers to source materials from reliable suppliers made its …
Ranbaxy unit fined $500m for selling adulterated drugs
May 14, 2013Manufacturing and Production FDA, GMP, Ranbaxy, fine, generics
Ranbaxy’s US subsidiary has agreed to pay fines and penalties totalling $500 million after pleading guilty to charges of manufacturing …
Takeda rapped over quality control failure in Japan
April 19, 2013Manufacturing and Production GMP, OPMA, Takeda
Takeda Pharmaceutical has been penalised by its local trade organisation over the quality failings that led to the recall of …
Risk-assessment for excipients: guideline out for comment
March 4, 2013Manufacturing and Production GMP, risk
The European Commission has published its long-awaited risk-assessment guideline for determining the level of Good Manufacturing Practice (GMP) needed for …
SFDA publishes high-risk excipients list
February 5, 2013Manufacturing and Production China, GMP, SFDA
China’s State Food and Drug Administration (SFDA) has published a list of 28 excipients which are considered high-risk and therefore …
Germany’s Hameln warned by FDA over GMP failings
January 22, 2013Manufacturing and Production FDA, GMP, Hameln
German contract manufacturer Hameln Pharmaceuticals was sent a warning letter by the FDA last month detailing a number of Good …
EMA sets out stall on medicine shortages
December 11, 2012Manufacturing and Production EMA, GMP, shortages
The European Medicines Agency has called for action at the EU level to tackle the issue of medicine shortages caused …
Excipient certification project moves forward
December 4, 2012Manufacturing and Production DEG, EXCiPACT, GDP, GMP
The EXCiPACT certification scheme for pharmaceutical excipients has taken a step closer to fruition with agreements now in place with …
Contaminated steroids blamed for deadly meningitis outbreak
October 25, 2012Manufacturing and Production FDA, GMP, NECC
As many as 14,000 patients may have been exposed to contaminated steriods that have led to 23 deaths due to …
EC publishes trio of revised GMP Guide sections
September 24, 2012Manufacturing and Production EC, EU, GMP, ICH
The European Commission has published two revised chapters in its Good Manufacturing Practice (GMP) Guide, along with an update of …
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