As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.
Bangalore, India-based Apotex and Verna, India-based Micro Labs both received warning letters last month from the US FDA detailing data integrity questions linked to their quality systems.
The EMA and the US FDA will conduct parallel assessment of QbD development and manufacturing data for new drug submissions under a new pilot scheme announced this week.
The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.
The WHO has published its views on the production of starting materials in draft guidance which details recommendations to ensure product quality while keeping costs down.
The US Food and Administration says that a new project examining the interaction between its review and facilities inspection arms will help improve inter-departmental communication, particularly during pre-approval inspections (PAI)
A technology partnership between ARTEL and Caliper Life Sciences
aims to enhance automated liquid delivery standards improving
laboratory data integrity. The collaboration aims to manufacture
technology to a level that is outlined...
