In the days of personalised medicine, 3D printing and nanotechnology, consultant David Chesney says regulators must “keep pace” to redefine current good manufacturing practice.
Efforts by Wockhardt to fix violations at drug plant in Wrexham, Wales are inadequate according to the US FDA which detailed its concerns in a warning letter this week.
The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
After finding cGMP violations at another Ranbaxy plant in India, the US FDA on Monday issued an import alert that effectively stops all of the plant’s drug shipments from entering the US.
Slovenian drugmaker Krka has paid just under $1.6m (€1m) for 7.5
per cent stakes in two Chinese drug and chemicals firms, namely
Zhejiang Menovo Pharmaceuticals and Anhui Menovo Pharmaceuticals.
Switzerland's Lonza has boosted its ability to make active
pharmaceutical ingredients (API) at its Visp site in response to
what it said was 'ever increasing hygienic and regulatory
requirements'.
The US Food and Drug Administration is planning to hold a meeting
in June to re-examine its regulations on electronic records and
signatures, used to generate the audit trail in the food and drug
industries, to examine whether some...
