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Set Alert for Manufacturing

US FDA Quality Metrics Initiative Continues Moving Forward … Quietly

Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.
Compliance Manufacturing Regulation

Latest From Manufacturing

Manufacturing Compliance Updates In Brief From US FDA And The EU

FDA issues five more drug GMP warning letters to drug manufacturers and active ingredient manufacturers at sites in India, China, and the US exhorting them to do a better job of testing ingredients and final products and to manage cross-contamination risks better. UK MHRA withdraws the GMP certificate for one Taiwanese API maker for its lack of knowledge of sterile processing. Meanwhile, FDA adds an Indian facility to its drug GMP import alert.
Europe United States

EMA Consults On Two-Step Process For Release And Shipping Of Investigational Products

The European Medicines Agency has issued a draft guideline to support the upcoming Clinical Trials Regulation, explaining how investigational medicinal products should be handled before they are sent to clinical trial sites. 
Europe Clinical Trials

PhRMA, BIO Mum On Trump’s Tariffs

While pressing the US trade representative for stronger IP protection, groups representing the brand biopharma sector remain silent on the Trump administration’s plan to hit China with 25% tariffs.

Manufacturing Trade

Generics, OTC AND API Groups Object To Proposed US Tariffs On Goods From China

AAM, CHPA, SOCMA and BPTF agree that proposed 25% tariffs on pharmaceuticals and APIs from China is a bad idea, unless perhaps it’s just a negotiating ploy.

Manufacturing Trade

Pharma Firms Alarmed By Australian Plans To Raise GMP Fees

Medicines Australia says that none of the options for recovering GMP costs set out in its consultation earlier this year are suitable, although views among individual pharmaceutical companies differ.

Australia Asia Pacific

Pharmaceutical Industry Not 'Reaping the Benefits' Of Quality Risk Management Tools, Expert Says

Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.

Manufacturing Quality
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