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GMP

Showing 15 posts of 51 posts found.

Fresenius Kabi hit by second FDA warning letter

July 10, 2013
Manufacturing 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. …

News
China image

China tightens quality standards for pharma distributors

July 2, 2013
Manufacturing 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 …

News
Novartis image

Novartis receives FDA warning

June 6, 2013
Manufacturing 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 …

News
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FDA issues draft guidance on contract manufacturing

June 3, 2013
Manufacturing 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The US Food and Drug Administration FDA has published draft guidance on quality agreements between pharma companies and contract manufacturers. …

News
Canada image

Canada tightens GMP rules for active ingredients

May 21, 2013
Manufacturing 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 …

News

Excipient certification scheme launches in US

May 17, 2013
Manufacturing and Production EXCiPACT, GMP

A certification scheme for pharmaceutical excipients to make it easier for drugmakers to source materials from reliable suppliers made its …

News
Ranbaxy image

Ranbaxy unit fined $500m for selling adulterated drugs

May 14, 2013
Manufacturing 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 …

News
Takeda image

Takeda rapped over quality control failure in Japan

April 19, 2013
Manufacturing 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 …

News

Risk-assessment for excipients: guideline out for comment

March 4, 2013
Manufacturing 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 …

News
Shanghai image

SFDA publishes high-risk excipients list

February 5, 2013
Manufacturing 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 …

News
FDA image

Germany’s Hameln warned by FDA over GMP failings

January 22, 2013
Manufacturing 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 …

News
EMA building

EMA sets out stall on medicine shortages

December 11, 2012
Manufacturing 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 …

News

Excipient certification project moves forward

December 4, 2012
Manufacturing 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 …

News
FDA image

Contaminated steroids blamed for deadly meningitis outbreak

October 25, 2012
Manufacturing 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 …

News

EC publishes trio of revised GMP Guide sections

September 24, 2012
Manufacturing 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 …

News
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