ICH

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US FDA offers plan for global regulatory harmonisation for generic drugs

October 19, 2018
Medical 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, 2013
Manufacturing 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, 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 …

Pharma manufacturing news in brief

September 17, 2012
Manufacturing 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, 2012
Manufacturing 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, 2011
Manufacturing 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 …

The Gateway to Local Adoption Series

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