US FDA Warns Indoco To Delve Further Into Manufacturing Deviation
Data integrity and process control found lacking
On paper, the tablet press was in control. In reality, it was not. What did that mean for the company? A lot more than it appeared to realize.
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ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.