GMP
Relief Therapeutics awarded approval from Swissmedic for new GMP-compliant laboratory
May 15, 2023Research 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, 2019Manufacturing 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, 2019Sales 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, 2019Research 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, 2016Manufacturing 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, 2015Manufacturing 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 slams GSK for manufacturing oversights
April 3, 2014Manufacturing 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 seeks more specialisation in agency structure
February 18, 2014Manufacturing 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 …
FDA and EMA team up for generic drug inspections
January 6, 2014Manufacturing 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 identifies GMP transgressors in public database
January 6, 2014Manufacturing 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, 2013Manufacturing 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 GMP revision comments focus on cross-contamination
December 3, 2013Manufacturing 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, 2013Manufacturing 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 …
MHRA recalls five Wockhardt medicines
October 18, 2013Manufacturing 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 …
AMRI says troubled Burlington plant back on track
July 24, 2013Manufacturing 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 …
