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US FDA Inspection In Store? Here Are Some Areas That May Be On Agency’s Radar

 
• By Anju Ghangurde

Risks like highly manual aseptic filling lines, poor root cause investigations and unwritten procedures were examined in Mumbai workshop.

Lachman_Officials
(L-R) Lachman executives David Lonza, Frances Zipp and Ron George

A recent workshop in Mumbai examined a host of issues around data integrity in manufacturing and beyond, including what US FDA inspectors are focusing on, areas where lapses are most prominent and the importance of tackling cultural gaps along the journey toward compliance.

Frances Zipp, CEO of Lachman Consultant Services, Inc., told the workshop on data integrity, data reliability and quality metrics that...

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