Pharmaceutical Inspection Cooperation Scheme member inspectorates are trying out the most comprehensive manufacturing data integrity guidance yet developed. Issued amid a flurry of guidance from various authorities, it could play a key role in harmonizing regulatory approaches.
An organization of 49 of the world's foremost pharmaceutical inspectorates has launched a six-month trial implementation of a guideline that could set the standard globally for enforcing data integrity in pharmaceutical manufacturing.
The Pharmaceutical Inspection Cooperation Scheme issued its 41-page draft guideline on a trial basis Aug. 10 to the 49 inspectorates that guard 46 nations from adulterated drugs. (Note:...
A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
