US FDA Inspection In Store? Here Are Some Areas That May Be On Agency’s Radar
Risks like highly manual aseptic filling lines, poor root cause investigations and unwritten procedures were examined in Mumbai workshop.
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Against a backdrop of US FDA warnings and global regulatory convergence, the Indian pharma industry is looking to build in quality from project inception and foster an unbiased approach to quality across global markets, a conference in Mumbai hears.
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.
The former CEO of Cipla’s India business is set to steer JB Chemicals and Pharmaceuticals, as the Indian firm embarks on a new phase of growth, backed by a revamped board, following its takeover by US private equity firm KKR.