Showing 15 posts of 51 posts found.

Relief Therapeutics awarded approval from Swissmedic for new GMP-compliant laboratory

May 15, 2023
Research and Development GMP, Relief Therapeutics, Swissmedic, laboratory

Swiss biopharmaceutical company Relief Therapeutics has announced that its state-of-the-art R&D laboratory in Balerna, Switzerland, has been audited and approved …


Singapore and South Korea agree to cooperate on Good Manufacturing Practice

November 26, 2019
Manufacturing and Production ASEAN, GMP, North Korea, ROK, Singapore, south korea

At a joint summit on Saturday, South Korea’s Ministry of Food and Drug Safety signed a memorandum of understanding (MOU) …


FDA and EMA fully implement mutual recognition agreement between US and EU

July 15, 2019
Sales and Marketing EMA, FDA, GMP, Slovakia, mra, mutual recognition, pharma

The FDA has recognised Slovakia’s ability to carry out inspections of manufacturing facilties. The recognition of Slovakia marks the full …


Poland and Slovenia included in US-EU mutual recognition agreement

February 20, 2019
Research and Development EU, GMP, Poland, Slovenia, USA, mutual recognition

Poland and Slovenia have been deemed capable of carrying out Good Manufacturing Practice (GMP) inspections at an equivalent level to …


MHRA suspends GMP certificate for Pfizer site in India

August 22, 2016
Manufacturing and Production, Sales and Marketing GMP, India, MHRA, Pfizer, ban, facility, import, suspend

The UK’s Medicines and Healthcare Products Agency (MHRA) has recommended that an Indian facility belonging to Pfizer’s Hospira unit be …


FDA bans drug imports from Indian plant

July 21, 2015
Manufacturing and Production Emcure, FDA, GMP, Good Manufacturing Practices, India, compliance, manufacturing, production, safety

The FDA has blocked US imports from the manufacturing plants of a major Indian pharmaceutical firm over safety fears. The …

FDA image

FDA slams GSK for manufacturing oversights

April 3, 2014
Manufacturing and Production FDA, GMP, GSK, Ireland, cork, mage, manufacturing

The FDA has warned GlaxoSmithKline that the US importation of products from the firm’s facility in Cork, Ireland could be …

FDA Hamburg image

FDA seeks more specialisation in agency structure

February 18, 2014
Manufacturing and Production FDA, GMP, ORA, fdasia, hamburg, opq, ufi

An internal review of the US Food and Drug Administration has concluded that the agency needs to restructure its compliance …

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FDA and EMA team up for generic drug inspections

January 6, 2014
Manufacturing and Production EMA, FDA, GMP, Taylor, manufacturing

The regulatory authorities in the US and EU have taken another step towards harmonisation by agreeing to pool their resources …

ema building

EMA identifies GMP transgressors in public database

January 6, 2014
Manufacturing and Production Database, EMA, GDP, GMP

The European Medicines Agency has continued its march towards increased transparency by publishing – for the first time – the …

FDA seeks top-to-toe review of Wockhardt manufacturing

December 9, 2013
Manufacturing and Production AZ, GMP, Taylor, Wockhardt. fda

Wockhardt has been asked to undertake an assessment of its entire manufacturing processes, according to an FDA warning letter. Sent …

EU image

EU GMP revision comments focus on cross-contamination

December 3, 2013
Manufacturing and Production Contamination, EFPIA, EU, GMP

Earlier this year the EU Commission published draft versions of four chapters in its Good Manufacturing Practice (GMP) guide, and …

Indian pharma exports ‘set for 20% growth’ to 2018

October 23, 2013
Manufacturing and Production API, CPhI, GMP, India, growth

Representatives of India’s pharma sector pledged to meet the government’s target of raising exports to $25 billion by 2016, as …

wockhardt image

MHRA recalls five Wockhardt medicines

October 18, 2013
Manufacturing and Production FDA, GMP, MHRA, Violations, Wockhardt, recall

The UK drugs regulator has recalled five more generic medicines made by Indian drugmaker Wockhardt after an inspection uncovered quality …

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AMRI says troubled Burlington plant back on track

July 24, 2013
Manufacturing and Production AMRI, FDA, GMP

It looks like contract research and manufacturing organisation AMRI can put the quality problems at its facility in Burlington behind …

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