ICH
US FDA offers plan for global regulatory harmonisation for generic drugs
October 19, 2018Medical Communications FDA, ICH, generic drugs, harmonisation, regulatory bodies
The US Food and Drug Administration (FDA) is offering a proposal to the International Council on Harmonisation (ICH) aimed at …
ICH starts consultation on elemental impurities guidance
August 7, 2013Manufacturing and Production ICH, Q3D, Taylor, USP
The International Conference on Harmonization (ICH) has started the consultation period on its long-awaited guidance on elemental impurities, a couple …
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 …
Pharma manufacturing news in brief
September 17, 2012Manufacturing and Production Ampio, DPT Labs, Ethypharm, ICH, PC Pharma, Ranbaxy
Ranbaxy and PC Pharma unveil new facility investments, Ethypharm will manufacture Ampio drug, DPT Labs is warned by the FDA …
Drugmakers ‘premature’ in requests for metal impurity data
April 5, 2012Manufacturing and Production ICH, manufacturing, metal impurity
Pharmaceutical manufacturers are acting ‘prematurely’ when asking excipient suppliers to provide metal impurity levels, according to a new position paper …
FDA process validation guidelines emphasise risk management
February 1, 2011Manufacturing and Production FDA, ICH, process validation
The FDA has published the final version of its Guideline on Process Validation, more than two years after the first …
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Santen joins inaugural Global Summit for Eye Health as partner
